DGFT Minutes
In force — no superseding record on file.
Government of India / भारत सरकार
Ministry of Commerce and Industry / वािणज्य और उद्योग मंत्रालय Department of Commerce / वािणज्य िवभाग Directorate General of Foreign Trade, Delhi / िवदेश व्यापार महािनदेशालय, िदल्ली
VANIJYA BHAWAN, AKBAR ROAD, CENTRAL DELHI, DELHI, 110011 / वािणज्य भवन, अकबर रोड, नई िदल्ली Email Office : dgft@nic.in , Phone Office : 011-23062777
MINUTES OF THE NORMS COMMITTEE- III
MEETING No. NC/3/MEET/Feb/202223/21 DATED: 22/02/2023
Please Note
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I. For information of exporters, Norms Committee - III handles all cases pertaining to fixation/ratification of norms for Export Products falling under ITC (HS) Chapter 29, 30 .Communications in respect of cases/pertaining to NC- III may be sent to email address: nc3.dgft@nic.in
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II. The Norms Committee has taken decision only with respect to technical aspect/wastage norms. While redeeming the applications, RAs should check that the applicant has fulfilled all requirements as prescribed in policy/procedure including those in Policy Circulars issued from time to time or any other provisions under FTP/HBP for EODC.
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III. Wherever the Committee has fixed Norms, the concerned RA may ensure that AA is issued on the wastages/consumption as ratified by the Committee or as per wastages claimed in the application, whichever is less.
Meeting No. NC/3/MEET/Feb/202223/21 dated 22/02/2023 of Norms Committee - III for the year 2022-23 was held on 22/02/2023 under the Chairmanship of Rajiv Soni ,Joint DGFT to consider the following applications for ratification of norms in respect of advance authorizations under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy 2015-20.
The following members were present in the meeting:-
| S.No. | Name and Designation of Representatives | Department |
|---|---|---|
| 1 | AJAY KUMAR,Deputy Director | DGFT(HQ) |
| 2 | NAND Lal,Technical Consultant | DGFT |
| 3 | DINESHNARAIN MATHUR,Technical<br>Consultant | DGFT |
This document has been digitally signed by AJAY KUMAR, Deputy Director on 07-03-2023 17:49:40.
1
)| |2|NAND Lal,Technical Consultant|DGFT| |3|DINESHNARAIN MATHUR,Technical<br>Consultant|DGFT|
This document has been digitally signed by AJAY KUMAR, Deputy Director on 07-03-2023 17:49:40.
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Case Details and Decision(s):
| Case No. | 1 / NC/3/MEET/Feb/202223/21 |
|---|---|
| Case Status | Case Deferred |
| Party Name | STERILE INDIA PRIVATE LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Feb/ 202223/ 21 and 22/02/2023 |
| HQ File Number | HQRNORM REVIW00000419AM23 |
| RA File Number | 05AA04037727 AM21 |
| Licence No and<br>Date | 0511001580/08/03/2021 |
| Norms Committee Decision:<br>Ms. Rekha Jangid, CA had attended the Personal Hearing and explained firm’s case. The Committee after hearing<br>explanation of Representative of the firm decided to call for following information / documents from the firm:<br>Complete description of Import Item.<br>i.<br>COA of Export Product.<br>ii.<br>COA of Import Item from foreign supplier.<br>iii.<br>DML.<br>iv.<br>It was observed that Ms. Rekha, who attended the Personal Hearing was not a Technical Representative. Hence,<br>it was decided to give a final opportunity to firm with the directions to send a Technical Representative to attend Personal<br>Hearing<br> before Norms Committee to explain its case. |
br>it was decided to give a final opportunity to firm with the directions to send a Technical Representative to attend Personal<br>Hearing<br> before Norms Committee to explain its case.||
| Case No. | 2 / NC/3/MEET/Feb/202223/21 |
|---|---|
| Case Status | Case Deferred |
| Party Name | ORIENTAL AROMATICS LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Feb/ 202223/ 21 and 22/02/2023 |
| HQ File Number | HQRNORM REVIW00003798AM23 |
| RA File Number | 03AA04029725 AM21 |
| Licence No and<br>Date | 0311002554/16/03/2021 |
| Norms Committee Decision:<br>Shri A.K. Mathur, V.P. (Technical) and Shri Amit Verma, Manager Marketing had attended the Personal Hearing and<br>explained firm’s case. The Committee after hearing explanation of Representative of the firm decided to call for<br>following information / documents from the firm: |
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i. Step wise percentage of yield.
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ii. Earlier approved norms for same export product / import item.
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iii. Production / Consumption data duly certified by GST.
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iv. Commercial value of By-Product.
e of yield.**
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ii. Earlier approved norms for same export product / import item.
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iii. Production / Consumption data duly certified by GST.
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iv. Commercial value of By-Product.
| Case No. | 3 / NC/3/MEET/Feb/202223/21 |
| Case Status | Case Rejected |
| Party Name | RAJASTHAN ANTIBIOTICS LTD |
| Meeting Number<br> | NC/ 3/ MEET/ Feb/ 202223/ 21 and 22/02/2023 |
| and Date | |
| HQ File Number | HQRNORM APPLY 00165816AM22 |
| RA File Number | 05AA04070414 AM22 |
| Licence No and<br>Date | 0511004197/18/08/2021 |
| Norms Committee Decision:<br>The firm was called to attend Personal Hearing on 07.02.2023 and 22.02.2023 vide e-mails dated 02.02.2023 and<br>14.02.2023. However, the firm did not respond to any of the mails sent to them.<br>In view of above, the Committee decided torejectthe case. | |
| RA concerned may take further necessary action as per above decision of NC. |
| Case No. | 4 / NC/3/MEET/Feb/202223/21 |
| Case Status | Case Approved |
| Party Name | DHANUKA LABORATORIES LIMITED |
| Meeting Number | |
| <br>and Date | NC/ 3/ MEET/ Feb/ 202223/ 21 and 22/02/2023 |
| HQ File Number | HQRNORM APPLY 00180144AM22 |
| RA File Number | 05AA04077131 AM22 |
| Licence No and<br>Date | 0511004616/08/09/2021 |
| Norms Committee Decision:<br>Shri Alok Srivastava, Sr. Vice President, Shri Yogendra Sachdeva, GM (R&D) and Shri Subhash Sharma, VP Operation<br>had attended the Personal Hearing and explained firm’s case. |
ommittee Decision:<br>Shri Alok Srivastava, Sr. Vice President, Shri Yogendra Sachdeva, GM (R&D) and Shri Subhash Sharma, VP Operation<br>had attended the Personal Hearing and explained firm’s case. The Committee heard the explanation of Representative of<br>the firm and after deliberations, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given|| |||
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|below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>PENICILLIN G POTASSIUM FIRST CRYSTAL<br>8.515 kg<br>2<br>Methylene Chloride<br>76.165 kg<br>3<br>Triethylamine<br>3.214 kg<br>4<br>Methanol<br>41.137 kg<br>5<br>Ethyl 4 Chloroacetoacetate<br>1.82 kg<br>6<br>Methyl 3 Methoxy Acrylate<br>1.62 kg<br>7<br>Prenol<br>3.114 kg<br>8<br>N N Dimethyl Formamide<br>12.16 kg<br>9<br>Ethyl Acetate<br>1.84 kg<br>10<br>Acetonitile<br>7.50 kg<br>11<br>Activated Carbon<br>0.200 kg<br>12<br>Acetone<br>1.20 kg<br>13<br>Toluene<br>23.00 kg<br>14<br>DL Malic Acid<br>7.173 kg<br>15<br>Acetic Acid<br>5.50 kg<br>16<br>Morpholine<br>3.47 kg<br>17<br>p Toluene Sulphonyl Chloride<br>1.88 kg<br>CEFTIBUTEN<br>USP/BP/EP/JP(POWDER)<br>1 kg|below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.
line<br>3.47 kg<br>17<br>p Toluene Sulphonyl Chloride<br>1.88 kg<br>CEFTIBUTEN<br>USP/BP/EP/JP(POWDER)<br>1 kg|below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>PENICILLIN G POTASSIUM FIRST CRYSTAL<br>8.515 kg<br>2<br>Methylene Chloride<br>76.165 kg<br>3<br>Triethylamine<br>3.214 kg<br>4<br>Methanol<br>41.137 kg<br>5<br>Ethyl 4 Chloroacetoacetate<br>1.82 kg<br>6<br>Methyl 3 Methoxy Acrylate<br>1.62 kg<br>7<br>Prenol<br>3.114 kg<br>8<br>N N Dimethyl Formamide<br>12.16 kg<br>9<br>Ethyl Acetate<br>1.84 kg<br>10<br>Acetonitile<br>7.50 kg<br>11<br>Activated Carbon<br>0.200 kg<br>12<br>Acetone<br>1.20 kg<br>13<br>Toluene<br>23.00 kg<br>14<br>DL Malic Acid<br>7.173 kg<br>15<br>Acetic Acid<br>5.50 kg<br>16<br>Morpholine<br>3.47 kg<br>17<br>p Toluene Sulphonyl Chloride<br>1.88 kg<br>CEFTIBUTEN<br>USP/BP/EP/JP(POWDER)<br>1 kg|below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.
line<br>3.47 kg<br>17<br>p Toluene Sulphonyl Chloride<br>1.88 kg<br>CEFTIBUTEN<br>USP/BP/EP/JP(POWDER)<br>1 kg|below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>PENICILLIN G POTASSIUM FIRST CRYSTAL<br>8.515 kg<br>2<br>Methylene Chloride<br>76.165 kg<br>3<br>Triethylamine<br>3.214 kg<br>4<br>Methanol<br>41.137 kg<br>5<br>Ethyl 4 Chloroacetoacetate<br>1.82 kg<br>6<br>Methyl 3 Methoxy Acrylate<br>1.62 kg<br>7<br>Prenol<br>3.114 kg<br>8<br>N N Dimethyl Formamide<br>12.16 kg<br>9<br>Ethyl Acetate<br>1.84 kg<br>10<br>Acetonitile<br>7.50 kg<br>11<br>Activated Carbon<br>0.200 kg<br>12<br>Acetone<br>1.20 kg<br>13<br>Toluene<br>23.00 kg<br>14<br>DL Malic Acid<br>7.173 kg<br>15<br>Acetic Acid<br>5.50 kg<br>16<br>Morpholine<br>3.47 kg<br>17<br>p Toluene Sulphonyl Chloride<br>1.88 kg<br>CEFTIBUTEN<br>USP/BP/EP/JP(POWDER)<br>1 kg|below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.
line<br>3.47 kg<br>17<br>p Toluene Sulphonyl Chloride<br>1.88 kg<br>CEFTIBUTEN<br>USP/BP/EP/JP(POWDER)<br>1 kg|below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>PENICILLIN G POTASSIUM FIRST CRYSTAL<br>8.515 kg<br>2<br>Methylene Chloride<br>76.165 kg<br>3<br>Triethylamine<br>3.214 kg<br>4<br>Methanol<br>41.137 kg<br>5<br>Ethyl 4 Chloroacetoacetate<br>1.82 kg<br>6<br>Methyl 3 Methoxy Acrylate<br>1.62 kg<br>7<br>Prenol<br>3.114 kg<br>8<br>N N Dimethyl Formamide<br>12.16 kg<br>9<br>Ethyl Acetate<br>1.84 kg<br>10<br>Acetonitile<br>7.50 kg<br>11<br>Activated Carbon<br>0.200 kg<br>12<br>Acetone<br>1.20 kg<br>13<br>Toluene<br>23.00 kg<br>14<br>DL Malic Acid<br>7.173 kg<br>15<br>Acetic Acid<br>5.50 kg<br>16<br>Morpholine<br>3.47 kg<br>17<br>p Toluene Sulphonyl Chloride<br>1.88 kg<br>CEFTIBUTEN<br>USP/BP/EP/JP(POWDER)<br>1 kg|below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.
line<br>3.47 kg<br>17<br>p Toluene Sulphonyl Chloride<br>1.88 kg<br>CEFTIBUTEN<br>USP/BP/EP/JP(POWDER)<br>1 kg|below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>PENICILLIN G POTASSIUM FIRST CRYSTAL<br>8.515 kg<br>2<br>Methylene Chloride<br>76.165 kg<br>3<br>Triethylamine<br>3.214 kg<br>4<br>Methanol<br>41.137 kg<br>5<br>Ethyl 4 Chloroacetoacetate<br>1.82 kg<br>6<br>Methyl 3 Methoxy Acrylate<br>1.62 kg<br>7<br>Prenol<br>3.114 kg<br>8<br>N N Dimethyl Formamide<br>12.16 kg<br>9<br>Ethyl Acetate<br>1.84 kg<br>10<br>Acetonitile<br>7.50 kg<br>11<br>Activated Carbon<br>0.200 kg<br>12<br>Acetone<br>1.20 kg<br>13<br>Toluene<br>23.00 kg<br>14<br>DL Malic Acid<br>7.173 kg<br>15<br>Acetic Acid<br>5.50 kg<br>16<br>Morpholine<br>3.47 kg<br>17<br>p Toluene Sulphonyl Chloride<br>1.88 kg<br>CEFTIBUTEN<br>USP/BP/EP/JP(POWDER)<br>1 kg|below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.
line<br>3.47 kg<br>17<br>p Toluene Sulphonyl Chloride<br>1.88 kg<br>CEFTIBUTEN<br>USP/BP/EP/JP(POWDER)<br>1 kg|below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>PENICILLIN G POTASSIUM FIRST CRYSTAL<br>8.515 kg<br>2<br>Methylene Chloride<br>76.165 kg<br>3<br>Triethylamine<br>3.214 kg<br>4<br>Methanol<br>41.137 kg<br>5<br>Ethyl 4 Chloroacetoacetate<br>1.82 kg<br>6<br>Methyl 3 Methoxy Acrylate<br>1.62 kg<br>7<br>Prenol<br>3.114 kg<br>8<br>N N Dimethyl Formamide<br>12.16 kg<br>9<br>Ethyl Acetate<br>1.84 kg<br>10<br>Acetonitile<br>7.50 kg<br>11<br>Activated Carbon<br>0.200 kg<br>12<br>Acetone<br>1.20 kg<br>13<br>Toluene<br>23.00 kg<br>14<br>DL Malic Acid<br>7.173 kg<br>15<br>Acetic Acid<br>5.50 kg<br>16<br>Morpholine<br>3.47 kg<br>17<br>p Toluene Sulphonyl Chloride<br>1.88 kg<br>CEFTIBUTEN<br>USP/BP/EP/JP(POWDER)<br>1 kg| |---|---|---|---|---|---| ||Export product|Qty.|Sl. No.|Import items|Qty.| ||CEFTIBUTEN<br>USP/BP/EP/JP(POWDER)|1 kg|1|PENICILLIN G POTASSIUM FIRST CRYSTAL|8.515 kg| ||||2|Methylene Chloride|76.165 kg| ||||3|Triethylamine|3.214 kg| ||||4|Methanol|41.137 kg| ||||5|Ethyl 4 Chloroacetoacetate|1.82 kg| ||||6|Methyl 3 Methoxy Acrylate|1.62 kg| ||||7|Prenol|3.114 kg| ||||8|N N Dimethyl Formamide|12.16 kg| ||||9|Ethyl Acetate|1.84 kg| ||||10|Acetonitile|7.50 kg| ||||11|Activated Carbon|0.200 kg| ||||12|Acetone|1.20 kg| ||||13|Toluene|23.00 kg| ||||14|DL Malic Acid|7.173 kg| ||||15|Acetic Acid|5.50 kg| ||||16|Morpholine|3.47 kg| ||||17|p Toluene Sulphonyl Chloride|1.88 kg|
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Acetone|1.20 kg| ||||13|Toluene|23.00 kg| ||||14|DL Malic Acid|7.173 kg| ||||15|Acetic Acid|5.50 kg| ||||16|Morpholine|3.47 kg| ||||17|p Toluene Sulphonyl Chloride|1.88 kg|
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18 Dimethyl Amino Pyridine 0.019 kg
RA concerned may take further necessary action as per above decision of NC.
| <br>R | 18 | Dime | thyl Amino Pyridine | 0.019 kg | 0.019 kg | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| <br>A concerned may take further necessary | action as | |||||||||||||
| per abov | e decision of NC. | |||||||||||||
| C | ase No. | 5 / NC/3/ME | ET/Feb/2 | 02223/21 | ||||||||||
| C | ase Status | Case Approv | ed | |||||||||||
| P | arty Name | DHANUKA | LABORA | TORIE | S LIMITED | |||||||||
| M | eeting Number and Date | NC/ 3/ MEE | T/ Feb/ 20 | 2223/ 21 | and 22/02/2023 | |||||||||
| H | Q File Number | HQRNORM | APPLY 0 | 0180145 | AM22 | |||||||||
| R | A File Number | 05AA040770 | 16 AM22 | |||||||||||
| L | icence No and Date | 0511004617/ | 08/09/20 | 21 | ||||||||||
| N<br>S<br>h<br>t<br>b | orms Committee Decision:<br>hri Alok Srivastava, Sr. Vice President,<br>ad attended the Personal Hearing and ex<br>he firm and after deliberations, it was de<br>elow or as applied by the firm, whicheve | Shri Yo<br>plained f<br>cided to r<br>r is less: | ||||||||||||
| gendra S<br>irm’s cas | achdeva, GM (R&D) and Shri Subhash<br>e. The Committee heard the explanati | Sharma, VP Operatio<br>on of Representative o | ||||||||||||
| atify adh | oc norms under Para 4.07 of HBP Vo | l. |
r>irm’s cas|||achdeva, GM (R&D) and Shri Subhash<br>e. The Committee heard the explanati|Sharma, VP Operatio<br>on of Representative o|||| ||||||||atify adh|||oc norms under Para 4.07 of HBP Vo|l. I as per details give|||| |||||||||||||||| |||||||||||||||| ||Export product|||Qty.||Sl. No.||Import items|||||Qty.|| |||||||||||||||| |||||||||||||||| ||CITICOLINE|SODIUM||<br>1 kg||1||CITYDINE 5 MONOPHOSPHATE|||||1.25 kg|| ||IP/BP/EP/JP(PO|WDER)||||||||||||| |||||||2||N N DICYCLOHEXYLCARBODIIMIDE|||||1.30 kg|| |||||||||||||||| |||||||||||||||| |||||||3||CALCIUM PHOSPHORYLCHOLINE CHLORIDE|||||2.25 kg|| |||||||||||||||| |||||||4||MORPHOLINE|||||067 k|| ||||||||||||||. g|| |||||||5||ISOPROPYL ALCOHOL|||||2.60 kg|| |||||||||||||||| |||||||6||ACTIVATED CARBON|||||0.200 kg|| |||||||||||||||| |||||||||||||||| |||||||7||METHANOL|||||4.10 kg|| |||||||||||||||| |||||||||||||||| |||||||8||METHYLENE CHLORIDE|||||3.73 kg||
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RA concerned may take further necessary action as per above decision of NC.
NOL|||||4.10 kg|| |||||||||||||||| |||||||||||||||| |||||||8||METHYLENE CHLORIDE|||||3.73 kg||
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RA concerned may take further necessary action as per above decision of NC.
| Case No. | Case No. | 6 / NC/3/MEET/Feb/202223/21 | 6 / NC/3/MEET/Feb/202223/21 | 6 / NC/3/MEET/Feb/202223/21 | 6 / NC/3/MEET/Feb/202223/21 | 6 / NC/3/MEET/Feb/202223/21 |
|---|---|---|---|---|---|---|
| Case Status | Case Approved | |||||
| Party Name | DHANUKA LABORATORIES LIMITED | |||||
| Meeting Number<br>and Date | NC/ 3/ MEET/ Feb/ 202223/ 21 and 22/02/2023 | |||||
| HQ File Number | HQRNORM APPLY 00180146AM22 | |||||
| RA File Number | 05AA04073979 AM22 | |||||
| Licence No and<br>Date | 0511004618/08/09/2021 | |||||
| Norms Committee Decision:<br>Shri Alok Srivastava, Sr. Vice President, Shri Yogendra Sachdeva, GM (R&D) and Shri Subhash Sharma, VP Operation<br>had attended the Personal Hearing and explained firm’s case. The Committee heard the explanation of Representative of<br>the firm and after deliberations, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given<br>below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Pencillin G Potassium First Crystal<br>8.515 kg<br>2<br>Methylene Chloride<br>76.165 kg<br>3<br>Triethylamine<br>3.214 kg<br>4<br>Methanol<br>41.137 kg<br>5<br>Ethyl 4 Chloroacetoacetate<br>1.82 kg<br>6<br>Methyl 3 Methoxy Acrylate<br>1.62 kg<br>7<br>Prenol<br>3.114 kg<br>8<br>N N Dimethyl Formamide<br>12.16 kg<br>CEFTIBUTEN<br>IP/EP/BP/JP(POWDER)<br>1 kg | ||||||
| Export product | Qty. | Sl. |
82 kg<br>6<br>Methyl 3 Methoxy Acrylate<br>1.62 kg<br>7<br>Prenol<br>3.114 kg<br>8<br>N N Dimethyl Formamide<br>12.16 kg<br>CEFTIBUTEN<br>IP/EP/BP/JP(POWDER)<br>1 kg||||||| ||Export product||Qty.|Sl. No.|Import items|Qty.| ||CEFTIBUTEN<br>IP/EP/BP/JP(POWDER)||1 kg|1|Pencillin G Potassium First Crystal|8.515 kg| |||||2|Methylene Chloride|76.165 kg| |||||3|Triethylamine|3.214 kg| |||||4|Methanol|41.137 kg| |||||5|Ethyl 4 Chloroacetoacetate|1.82 kg| |||||6|Methyl 3 Methoxy Acrylate|1.62 kg| |||||7|Prenol|3.114 kg| |||||8|N N Dimethyl Formamide|12.16 kg|
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| 9<br>Ethyl Acetate<br>1.84 kg<br>10<br>Acetonitile<br>7.50 kg<br>11<br>Activated Carbon<br>0.200 kg<br>12<br>Acetone<br>1.20 kg<br>13<br>Toluene<br>23.00 kg<br>14<br>DL Malic Acid<br>7.173 kg<br>15<br>Acetic Acid<br>5.50 kg<br>16<br>Morpholine<br>3.47 kg<br>17<br>p Toluene Sulphonyl Chloride<br>1.88 kg<br>18<br>Dimethyl Amino Pyridine<br>0.019 kg<br>RA concerned may take further necessary action as per above decision of NC. | 9 | Ethyl Acetate | 1.84 kg | ||
|---|---|---|---|---|---|
| 10 | Acetonitile | 7.50 kg | |||
| 11 | Activated Carbon | 0.200 kg | |||
| 12 | Acetone | 1.20 kg | |||
| 13 | Toluene | 23.00 kg | |||
| 14 | DL Malic Acid | 7.173 kg | |||
| 15 | Acetic Acid | 5.50 kg | |||
| 16 | Morpholine | 3.47 kg | |||
| 17 | p Toluene Sulphonyl Chloride | 1.88 kg | |||
| 18 | Dimethyl Amino Pyridine | 0.019 kg |
RA concerned may take further necessary action as per above decision of NC.
0 kg| ||||16|Morpholine|3.47 kg| ||||17|p Toluene Sulphonyl Chloride|1.88 kg| ||||18|Dimethyl Amino Pyridine|0.019 kg|
RA concerned may take further necessary action as per above decision of NC.
| Case No. | 7 / NC/3/MEET/Feb/202223/21 |
|---|---|
| Case Status | Case Approved |
| Party Name | DHANUKA LABORATORIES LIMITED |
| Meeting Number and<br>Date | NC/ 3/ MEET/ Feb/ 202223/ 21 and 22/02/2023 |
| HQ File Number | HQRNORM APPLY 00183913AM22 |
| RA File Number | 05AA04078246 AM22 |
| Licence No and Date | 0511004729/14/09/2021 |
| Norms Committee Decision:<br>Shri Alok Srivastava, Sr. Vice President, Shri Yogendra Sachdeva, GM (R&D) and Shri Subhash Sharma, VP Operation<br>had attended the Personal Hearing and explained firm’s case. The Committee heard the explanation of Representative of<br>the firm and after deliberations, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given<br>below or as applied by the firm, whichever is less: |
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and after deliberations, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given<br>below or as applied by the firm, whichever is less:||
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|Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Pencillin G Potassium First Crystal<br>8.515 kg<br>2<br>Methylene Chloride<br>76.165 kg<br>3<br>Triethylamine<br>3.214 kg<br>4<br>Methanol<br>41.137 kg<br>5<br>Ethyl 4 Chloroacetoacetate<br>1.82 kg<br>6<br>Methyl 3 Methoxy Acrylate<br>1.62 kg<br>7<br>Prenol<br>3.114 kg<br>8<br>N N Dimethyl Formamide<br>12.16 kg<br>9<br>Ethyl Acetate<br>1.84 kg<br>10<br>Acetonitile<br>7.50 kg<br>11<br>Activated Carbon<br>0.200 kg<br>12<br>Acetone<br>1.20 kg<br>13<br>Toluene<br>23.00 kg<br>14<br>DL Malic Acid<br>7.173 kg<br>15<br>Acetic Acid<br>5.50 kg<br>16<br>Morpholine<br>3.47 kg<br>17<br>p Toluene Sulphonyl Chloride<br>1.88 kg<br>CEFTIBUTEN<br>USP/EP/BP/IP/JP(62/POWDER)<br>1 kg|Export product<br>Qty.<br>Sl.
73 kg<br>15<br>Acetic Acid<br>5.50 kg<br>16<br>Morpholine<br>3.47 kg<br>17<br>p Toluene Sulphonyl Chloride<br>1.88 kg<br>CEFTIBUTEN<br>USP/EP/BP/IP/JP(62/POWDER)<br>1 kg|Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Pencillin G Potassium First Crystal<br>8.515 kg<br>2<br>Methylene Chloride<br>76.165 kg<br>3<br>Triethylamine<br>3.214 kg<br>4<br>Methanol<br>41.137 kg<br>5<br>Ethyl 4 Chloroacetoacetate<br>1.82 kg<br>6<br>Methyl 3 Methoxy Acrylate<br>1.62 kg<br>7<br>Prenol<br>3.114 kg<br>8<br>N N Dimethyl Formamide<br>12.16 kg<br>9<br>Ethyl Acetate<br>1.84 kg<br>10<br>Acetonitile<br>7.50 kg<br>11<br>Activated Carbon<br>0.200 kg<br>12<br>Acetone<br>1.20 kg<br>13<br>Toluene<br>23.00 kg<br>14<br>DL Malic Acid<br>7.173 kg<br>15<br>Acetic Acid<br>5.50 kg<br>16<br>Morpholine<br>3.47 kg<br>17<br>p Toluene Sulphonyl Chloride<br>1.88 kg<br>CEFTIBUTEN<br>USP/EP/BP/IP/JP(62/POWDER)<br>1 kg|Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Pencillin G Potassium First Crystal<br>8.515 kg<br>2<br>Methylene Chloride<br>76.165 kg<br>3<br>Triethylamine<br>3.214 kg<br>4<br>Methanol<br>41.137 kg<br>5<br>Ethyl 4 Chloroacetoacetate<br>1.82 kg<br>6<br>Methyl 3 Methoxy Acrylate<br>1.62 kg<br>7<br>Prenol<br>3.114 kg<br>8<br>N N Dimethyl Formamide<br>12.16 kg<br>9<br>Ethyl Acetate<br>1.84 kg<br>10<br>Acetonitile<br>7.50 kg<br>11<br>Activated Carbon<br>0.200 kg<br>12<br>Acetone<br>1.20 kg<br>13<br>Toluene<br>23.00 kg<br>14<br>DL Malic Acid<br>7.173 kg<br>15<br>Acetic Acid<br>5.50 kg<br>16<br>Morpholine<br>3.47 kg<br>17<br>p Toluene Sulphonyl Chloride<br>1.88 kg<br>CEF
cetone<br>1.20 kg<br>13<br>Toluene<br>23.00 kg<br>14<br>DL Malic Acid<br>7.173 kg<br>15<br>Acetic Acid<br>5.50 kg<br>16<br>Morpholine<br>3.47 kg<br>17<br>p Toluene Sulphonyl Chloride<br>1.88 kg<br>CEFTIBUTEN<br>USP/EP/BP/IP/JP(62/POWDER)<br>1 kg|Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Pencillin G Potassium First Crystal<br>8.515 kg<br>2<br>Methylene Chloride<br>76.165 kg<br>3<br>Triethylamine<br>3.214 kg<br>4<br>Methanol<br>41.137 kg<br>5<br>Ethyl 4 Chloroacetoacetate<br>1.82 kg<br>6<br>Methyl 3 Methoxy Acrylate<br>1.62 kg<br>7<br>Prenol<br>3.114 kg<br>8<br>N N Dimethyl Formamide<br>12.16 kg<br>9<br>Ethyl Acetate<br>1.84 kg<br>10<br>Acetonitile<br>7.50 kg<br>11<br>Activated Carbon<br>0.200 kg<br>12<br>Acetone<br>1.20 kg<br>13<br>Toluene<br>23.00 kg<br>14<br>DL Malic Acid<br>7.173 kg<br>15<br>Acetic Acid<br>5.50 kg<br>16<br>Morpholine<br>3.47 kg<br>17<br>p Toluene Sulphonyl Chloride<br>1.88 kg<br>CEFTIBUTEN<br>USP/EP/BP/IP/JP(62/POWDER)<br>1 kg|Export product<br>Qty.<br>Sl.
73 kg<br>15<br>Acetic Acid<br>5.50 kg<br>16<br>Morpholine<br>3.47 kg<br>17<br>p Toluene Sulphonyl Chloride<br>1.88 kg<br>CEFTIBUTEN<br>USP/EP/BP/IP/JP(62/POWDER)<br>1 kg|Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Pencillin G Potassium First Crystal<br>8.515 kg<br>2<br>Methylene Chloride<br>76.165 kg<br>3<br>Triethylamine<br>3.214 kg<br>4<br>Methanol<br>41.137 kg<br>5<br>Ethyl 4 Chloroacetoacetate<br>1.82 kg<br>6<br>Methyl 3 Methoxy Acrylate<br>1.62 kg<br>7<br>Prenol<br>3.114 kg<br>8<br>N N Dimethyl Formamide<br>12.16 kg<br>9<br>Ethyl Acetate<br>1.84 kg<br>10<br>Acetonitile<br>7.50 kg<br>11<br>Activated Carbon<br>0.200 kg<br>12<br>Acetone<br>1.20 kg<br>13<br>Toluene<br>23.00 kg<br>14<br>DL Malic Acid<br>7.173 kg<br>15<br>Acetic Acid<br>5.50 kg<br>16<br>Morpholine<br>3.47 kg<br>17<br>p Toluene Sulphonyl Chloride<br>1.88 kg<br>CEFTIBUTEN<br>USP/EP/BP/IP/JP(62/POWDER)<br>1 kg|Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Pencillin G Potassium First Crystal<br>8.515 kg<br>2<br>Methylene Chloride<br>76.165 kg<br>3<br>Triethylamine<br>3.214 kg<br>4<br>Methanol<br>41.137 kg<br>5<br>Ethyl 4 Chloroacetoacetate<br>1.82 kg<br>6<br>Methyl 3 Methoxy Acrylate<br>1.62 kg<br>7<br>Prenol<br>3.114 kg<br>8<br>N N Dimethyl Formamide<br>12.16 kg<br>9<br>Ethyl Acetate<br>1.84 kg<br>10<br>Acetonitile<br>7.50 kg<br>11<br>Activated Carbon<br>0.200 kg<br>12<br>Acetone<br>1.20 kg<br>13<br>Toluene<br>23.00 kg<br>14<br>DL Malic Acid<br>7.173 kg<br>15<br>Acetic Acid<br>5.50 kg<br>16<br>Morpholine<br>3.47 kg<br>17<br>p Toluene Sulphonyl Chloride<br>1.88 kg<br>CEF
cetone<br>1.20 kg<br>13<br>Toluene<br>23.00 kg<br>14<br>DL Malic Acid<br>7.173 kg<br>15<br>Acetic Acid<br>5.50 kg<br>16<br>Morpholine<br>3.47 kg<br>17<br>p Toluene Sulphonyl Chloride<br>1.88 kg<br>CEFTIBUTEN<br>USP/EP/BP/IP/JP(62/POWDER)<br>1 kg| |---|---|---|---|---|---| ||Export product|Qty.|Sl. No.|Import items|Qty.| ||CEFTIBUTEN<br>USP/EP/BP/IP/JP(62/POWDER)|1 kg|1|Pencillin G Potassium First Crystal|8.515 kg| ||||2|Methylene Chloride|76.165 kg| ||||3|Triethylamine|3.214 kg| ||||4|Methanol|41.137 kg| ||||5|Ethyl 4 Chloroacetoacetate|1.82 kg| ||||6|Methyl 3 Methoxy Acrylate|1.62 kg| ||||7|Prenol|3.114 kg| ||||8|N N Dimethyl Formamide|12.16 kg| ||||9|Ethyl Acetate|1.84 kg| ||||10|Acetonitile|7.50 kg| ||||11|Activated Carbon|0.200 kg| ||||12|Acetone|1.20 kg| ||||13|Toluene|23.00 kg| ||||14|DL Malic Acid|7.173 kg| ||||15|Acetic Acid|5.50 kg| ||||16|Morpholine|3.47 kg| ||||17|p Toluene Sulphonyl Chloride|1.88 kg|
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18 Dimethyl Amino Pyridine 0.019 kg RA concerned may take further necessary action as per above decision of NC.
line|3.47 kg| ||||17|p Toluene Sulphonyl Chloride|1.88 kg|
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18 Dimethyl Amino Pyridine 0.019 kg RA concerned may take further necessary action as per above decision of NC.
| Case No. | 8 / NC/3/MEET/Feb/202223/21 | |
|---|---|---|
| Case Status | Case Deferred | |
| Party Name | NATURAL AND ESSENTIAL OILS PRIVATE LIMITED | |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Feb/ 202223/ 21 and 22/02/2023 | |
| HQ File Number | HQRNORM APPLY 00196404AM22 | |
| RA File Number | 07AA04026654 AM22 | |
| Licence No and<br>Date | 0711002016/28/09/2021 | |
| Norms Committee | Decision: | |
| Shri Ramesh Kannan, Manager and Shri Sathyanarayana G, Advocate had attended the Personal Hearing and | ||
| explained firm’s | case. The Committee after hearing explanation of Representative of the firm decided to call for | |
| following information / documents from the firm: | ||
| COA of import item from foreign supplier.<br>i. | ||
| COA of both the export product in support of purity claimed.<br>ii. | ||
| Get the Advance Authorization amended from RA.<br>iii. |
| |COA of import item from foreign supplier.<br>i.||| |COA of both the export product in support of purity claimed.<br>ii.||| |Get the Advance Authorization amended from RA.<br>iii.|||
| Case No. | 9 / NC/3/MEET/Feb/202223/21 |
|---|---|
| Case Status | Case Deferred |
| Party Name | HONOUR LAB LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Feb/ 202223/ 21 and 22/02/2023 |
| HQ File Number | HQRNORM APPLY 00197140AM22 |
| RA File Number | 09AA04015351 AM22 |
| Licence No and<br>Date | 0911001652/29/09/2021 |
| Norms Committee Decision: | |
| The firm vide e-mail dated 22.02.2023 has stated that their Technical Director is on long leave due to some personal reasons | |
| and he is expected to join in second week of March, 2023. Accordingly, the firm has requested to grant them any date in |
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Second week of March, 2023 so that they could attend the Personal Hearing .
The Committee considered the request of firm and it was decided to defer the case.
in||
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Second week of March, 2023 so that they could attend the Personal Hearing .
The Committee considered the request of firm and it was decided to defer the case.
| S<br> | econd week of March, 2023 so that th<br>The Committee considered | econd week of March, 2023 so that th<br>The Committee considered | econd week of March, 2023 so that th<br>The Committee considered | econd week of March, 2023 so that th<br>The Committee considered | ey could a<br>the reque | ey could a<br>the reque | ttend the | ttend the | Personal Hearing<br>. | Personal Hearing<br>. | Personal Hearing<br>. | Personal Hearing<br>. | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| st of firm | and it was decided to defer the case. | |||||||||||||
| C | ase No. | 10 / NC/3/MEET/F | eb/20222 | 3/21 | ||||||||||
| C | ase Status | Case Approved | ||||||||||||
| P | arty Name | DHANUKA LAB | ORATOR | IES LIM | ITED | |||||||||
| M<br>a | eeting Number<br>nd Date | NC/ 3/ MEET/ Feb | / 202223/ | |||||||||||
| 21 and | 22/02/2023 | |||||||||||||
| H | Q File Number | HQRNORM APPL | Y 00291 | 684AM2 | 2 | |||||||||
| R | A File Number | 05AX04000180 A | M22 | |||||||||||
| Licence No and<br>Date | icence No and<br> | 0511007032/20/12 | /2021 | |||||||||||
| Norms Committee Decision:<br>Shri Alok Srivastava, Sr. Vice President, Shri Yogendra Sachdeva, GM (R&D) and Shri Subhash Sharma, VP Operation<br>had attended the Personal Hearing and explained firm’s case. |
ommittee Decision:<br>Shri Alok Srivastava, Sr. Vice President, Shri Yogendra Sachdeva, GM (R&D) and Shri Subhash Sharma, VP Operation<br>had attended the Personal Hearing and explained firm’s case. The Committee heard the explanation of Representative of||||||||||||||| |<br>the firm and after deliberations, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given||||||||||||||| |below or as applied by the|||firm, whichever is less:|||||||||||| |||||||||||||||| |||||||||||||||| |||||||||||||||| ||Export product|||Qty.||Sl. No.||Import items||||||Qty.| |||||||||||||||| |||||||||||||||| ||CEFTIBUTEN|||1 kg||1||Pencillin G Potassium First Crystal||||||8.515 kg| ||<br>IP/EP/BP/JP(POWDER)|||||||||||||| |||||||2||METHYLENE CHLORIDE /Dichloromethane||||||76.165 kg| |||||||3||Triethylamine||||||3.214 kg| |||||||4||M||ethanol||||41.137 kg| |||||||||||||||| |||||||5||Et||hyl-4-chloro|acetoacetate|||1.82 kg| |||||||||||||||| |||||||6||M||ethyl-3-meth|oxy acrylate|||1.62 kg| |||||||7||Pr||l||||3114 k| |||||||||||eno||||. g| ||||||||||||||||
||||||||||| |||||||5||Et||hyl-4-chloro|acetoacetate|||1.82 kg| |||||||||||||||| |||||||6||M||ethyl-3-meth|oxy acrylate|||1.62 kg| |||||||7||Pr||l||||3114 k| |||||||||||eno||||. g| ||||||||||||||||
| S<br> | econd week of March, 2023 so that th<br>The Committee considered | econd week of March, 2023 so that th<br>The Committee considered | econd week of March, 2023 so that th<br>The Committee considered | econd week of March, 2023 so that th<br>The Committee considered | ey could a<br>the reque | ey could a<br>the reque | ttend the | ttend the | Personal Hearing<br>. | Personal Hearing<br>. | Personal Hearing<br>. | Personal Hearing<br>. | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| st of firm | and it was decided to defer the case. | |||||||||||||
| C | ase No. | 10 / NC/3/MEET/F | eb/20222 | 3/21 | ||||||||||
| C | ase Status | Case Approved | ||||||||||||
| P | arty Name | DHANUKA LAB | ORATOR | IES LIM | ITED | |||||||||
| M<br>a | eeting Number<br>nd Date | NC/ 3/ MEET/ Feb | / 202223/ | |||||||||||
| 21 and | 22/02/2023 | |||||||||||||
| H | Q File Number | HQRNORM APPL | Y 00291 | 684AM2 | 2 | |||||||||
| R | A File Number | 05AX04000180 A | M22 | |||||||||||
| Licence No and<br>Date | icence No and<br> | 0511007032/20/12 | /2021 | |||||||||||
| Norms Committee Decision:<br>Shri Alok Srivastava, Sr. Vice President, Shri Yogendra Sachdeva, GM (R&D) and Shri Subhash Sharma, VP Operation<br>had attended the Personal Hearing and explained firm’s case. |
ommittee Decision:<br>Shri Alok Srivastava, Sr. Vice President, Shri Yogendra Sachdeva, GM (R&D) and Shri Subhash Sharma, VP Operation<br>had attended the Personal Hearing and explained firm’s case. The Committee heard the explanation of Representative of||||||||||||||| |<br>the firm and after deliberations, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given||||||||||||||| |below or as applied by the|||firm, whichever is less:|||||||||||| |||||||||||||||| |||||||||||||||| |||||||||||||||| ||Export product|||Qty.||Sl. No.||Import items||||||Qty.| |||||||||||||||| |||||||||||||||| ||CEFTIBUTEN|||1 kg||1||Pencillin G Potassium First Crystal||||||8.515 kg| ||<br>IP/EP/BP/JP(POWDER)|||||||||||||| |||||||2||METHYLENE CHLORIDE /Dichloromethane||||||76.165 kg| |||||||3||Triethylamine||||||3.214 kg| |||||||4||M||ethanol||||41.137 kg| |||||||||||||||| |||||||5||Et||hyl-4-chloro|acetoacetate|||1.82 kg| |||||||||||||||| |||||||6||M||ethyl-3-meth|oxy acrylate|||1.62 kg| |||||||7||Pr||l||||3114 k| |||||||||||eno||||. g| ||||||||||||||||
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| 8 | N,N-Dimethyl Formamide | 12.16 kg | |
|---|---|---|---|
| 9 | Acetonitile | 7.50 kg | |
| 10 | Activated Carbon | 0.200 kg | |
| 11 | Acetone | 1.20 kg | |
| 12 | Toluene | 23.00 kg | |
| 13 | DL-Malic acid | 7.173 kg | |
| 14 | Acetic Acid | 5.50 kg | |
| 15 | Morpholine | 3.47 kg | |
| 16 | Dimethyl amino pyridine | 0.019 kg |
RA concerned may take further necessary action as per above decision of NC.
||13|DL-Malic acid|7.173 kg| ||14|Acetic Acid|5.50 kg| ||15|Morpholine|3.47 kg| ||16|Dimethyl amino pyridine|0.019 kg|
RA concerned may take further necessary action as per above decision of NC.
| Case No.<br>11 / NC/3/MEET/Feb/202223/21 |
|---|
| Case Status<br>Case Approved |
| Party Name<br>DHANUKA LABORATORIES LIMITED |
| Meeting Number<br>and Date<br>NC/ 3/ MEET/ Feb/ 202223/ 21 and 22/02/2023 |
| HQ File Number<br>HQRNORM APPLY 00291953AM22 |
| RA File Number<br>05AX04000176 AM22 |
| Licence No and<br>Date<br>0511007040/20/12/2021 |
| Norms Committee Decision: |
| Shri Alok Srivastava, Sr. Vice President, Shri Yogendra Sachdeva, GM (R&D) and Shri Subhash Sharma, VP Operation |
| had attended the Personal Hearing and explained firm’s case. The Committee heard the explanation of Representative of |
| the firm and after deliberations, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given |
| below or as applied by the firm, whichever is less: |
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and after deliberations, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given| |below or as applied by the firm, whichever is less:|
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|Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Pencillin G Potassium First Crystal<br>8.515 kg<br>2<br>METHYLENE CHLORIDE /Dichloromethane 76.165 kg<br>3<br>Triethylamine<br>3.214 kg<br>4<br>Methanol<br>41.137 kg<br>5<br>Ethyl-4-chloroacetoacetate<br>1.82 kg<br>6<br>Methyl-3-methoxy acrylate<br>1.62 kg<br>7<br>Prenol<br>3.114 kg<br>8<br>N,N-Dimethyl Formamide<br>12.16 kg<br>9<br>Acetonitile<br>7.50 kg<br>10<br>Activated Carbon<br>0.200 kg<br>11<br>Acetone<br>1.20 kg<br>12<br>Toluene<br>23.00 kg<br>13<br>DL-Malic acid<br>7.173 kg<br>14<br>Acetic Acid<br>5.50 kg<br>15<br>Morpholine<br>3.47 kg<br>CEFTIBUTEN<br>IP/EP/BP/JP(POWDER)<br>1 kg<br>16<br>Dimethyl Amino Pyridine<br>0.019 kg<br>RA concerned may take further necessary action as per above decision of NC.|Export product|Qty.|Sl.
| .47 kg<br>CEFTIBUTEN<br>IP/EP/BP/JP(POWDER)<br>1 kg<br>16<br>Dimethyl Amino Pyridine<br>0.019 kg<br>RA concerned may take further necessary action as per above decision of NC. | Export product | Qty. | Sl. No. | Import items | Qty. |
|---|---|---|---|---|---|
| CEFTIBUTEN<br>IP/EP/BP/JP(POWDER) | 1 kg | 1 | Pencillin G Potassium First Crystal | 8.515 kg | |
| 2 | METHYLENE CHLORIDE /Dichloromethane | 76.165 kg | |||
| 3 | Triethylamine | 3.214 kg | |||
| 4 | Methanol | 41.137 kg | |||
| 5 | Ethyl-4-chloroacetoacetate | 1.82 kg | |||
| 6 | Methyl-3-methoxy acrylate | 1.62 kg | |||
| 7 | Prenol | 3.114 kg | |||
| 8 | N,N-Dimethyl Formamide | 12.16 kg | |||
| 9 | Acetonitile | 7.50 kg | |||
| 10 | Activated Carbon | 0.200 kg | |||
| 11 | Acetone | 1.20 kg | |||
| 12 | Toluene | 23.00 kg | |||
| 13 | DL-Malic acid | 7.173 kg | |||
| 14 | Acetic Acid | 5.50 kg | |||
| 15 | Morpholine | 3.47 kg | |||
| 16 | Dimethyl Amino Pyridine | 0.019 kg |
RA concerned may take further necessary action as per above decision of NC.
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| Case No. | 12 / NC/3/MEET/Feb/202223/21 |
|---|---|
| Case Status | Case Rejected |
| Party Name | LAXMI ORGANIC INDUSTRIES LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Feb/ 202223/ 21 and 22/02/2023 |
| HQ File Number | HQRNORM APPLY 00351870AM22 |
| RA File Number | 03AX04000936 AM22 |
| Licence No and<br>Date | 0311011342/11/02/2022 |
| Norms Committee Decision: | |
| The firm was called to attend Personal Hearing on 07.02.2023 and 22.02.2023 vide e-mails dated 02.02.2023 and | |
| 14.02.2023. |
icence No and<br>Date|0311011342/11/02/2022| |Norms Committee Decision:|| |The firm was called to attend Personal Hearing on 07.02.2023 and 22.02.2023 vide e-mails dated 02.02.2023 and|| |14.02.2023. However, the firm did not respond to any of the mails sent to them.|| |In view of above, the Committee decided torejectthe case.|| |RA concerned may take further necessary action as per above decision of NC.||
| Case No.<br>13 / NC/3/MEET/Feb/202223/21 | Case No.<br>13 / NC/3/MEET/Feb/202223/21 | |||
|---|---|---|---|---|
| Case Status<br>Case Approved | ||||
| Party Name<br>DHANUKA LABORATORIES LIMITED | ||||
| Meeting Number<br>and Date<br>NC/ 3/ MEET/ Feb/ 202223/ 21 and 22/02/2023 | ||||
| HQ File Number<br>HQRNORM APPLY 00364287AM22 | ||||
| RA File Number<br>05AX04001048 AM22 | ||||
| Licence No and<br>Date<br>0511010134/23/02/2022 | ||||
| Norms Committee Decision: | ||||
| Shri Alok Srivastava, Sr. Vice President, Shri Yogendra Sachdeva, GM (R&D) and Shri Subhash Sharma, VP Operation | ||||
| had attended the Personal Hearing and explained firm’s case. The Committee heard the explanation of Representative of | ||||
| the firm and after deliberations, it was decided to ratify | adhoc norms under Para 4.07 of HBP Vol. I as per details given | |||
| below or as applied by the firm, whichever is less: | ||||
| Export product<br>Qty. | Sl. No. | Import items | Qty. |
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orms under Para 4.07 of HBP Vol. I as per details given||| |below or as applied by the firm, whichever is less:||||| |Export product<br>Qty.|Sl. No.|Import items|Qty.||
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| 1<br>Pencillin G Potassium First Crystal<br>8.515 kg<br>2<br>METHYLENE CHLORIDE /Dichloromethane<br>76.165 kg<br>3<br>Triethylamine<br>3.214 kg<br>4<br>Methanol<br>41.137 kg<br>5<br>Ethyl 4 -Chloroacetoacetate<br>1.82 kg<br>6<br>Methyl 3 Methoxy Acrylate<br>1.62 kg<br>7<br>Prenol<br>3.114 kg<br>8<br>N N-Dimethyl Formamide<br>12.16 kg<br>9<br>Acetonitile<br>7.50 kg<br>10<br>Activated Carbon<br>0.200 kg<br>11<br>Acetone<br>1.20 kg<br>12<br>Toluene<br>23.00 kg<br>CEFTIBUTEN<br>USP/EP/BP/IP/JP<br>(POWDER)<br>1 kg<br>13<br>Acetic Acid<br>5.50 kg<br>RA concerned may take further necessary action as per above decision of NC. | CEFTIBUTEN<br>USP/EP/BP/IP/JP<br>(POWDER) | 1 kg | 1 | Pencillin G Potassium First Crystal | 8.515 kg |
|---|---|---|---|---|---|
| 2 | METHYLENE CHLORIDE /Dichloromethane | 76.165 kg | |||
| 3 | Triethylamine | 3.214 kg | |||
| 4 | Methanol | 41.137 kg | |||
| 5 | Ethyl 4 -Chloroacetoacetate | 1.82 kg | |||
| 6 | Methyl 3 Methoxy Acrylate | 1.62 kg | |||
| 7 | Prenol | 3.114 kg | |||
| 8 | N N-Dimethyl Formamide | 12.16 kg | |||
| 9 | Acetonitile | 7.50 kg | |||
| 10 | Activated Carbon | 0.200 kg | |||
| 11 | Acetone | 1.20 kg | |||
| 12 | Toluene | 23.00 kg | |||
| 13 | Acetic Acid | 5.50 kg |
RA concerned may take further necessary action as per above decision of NC.
.50 kg| ||||10|Activated Carbon|0.200 kg| ||||11|Acetone|1.20 kg| ||||12|Toluene|23.00 kg| ||||13|Acetic Acid|5.50 kg|
RA concerned may take further necessary action as per above decision of NC.
| Case No. | 14 / NC/3/MEET/Feb/202223/21 |
|---|---|
| Case Status | Case Approved |
| Party Name | AROCHEMA INGREDIENTS PRIVATE LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Feb/ 202223/ 21 and 22/02/2023 |
| HQ File Number | HQRNORM APPLY 00374231AM22 |
| RA File Number | 26AX04000019 AM22 |
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| Licence No and<br>Date<br>2611000488/03/03/2022 | ||
|---|---|---|
| Norms Committee Decision: | ||
| Shri R. Kumarasamy, VP (Site Operation) and Shri Shivananda Shetty, Head – Finance had attended the Personal | ||
| Hearing and explained firm’s case. The Committee heard the explanation of Representative of the firm and after | ||
| deliberations, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as | ||
| applied by the firm, whichever is less: | ||
| Export product<br>Qty.<br>Sl. No. Import items | Qty. | |
| 1<br>SCLAREOLIDE (90% purity)<br>ORCANOX<br>1 kg | 1.4987 kg | |
| 2<br>TERT - AMYL ALCOHOL | 2.64 kg | |
| <br>RA concerned may take further necessary action as per above decision of NC. |
t items|Qty.|| |1<br>SCLAREOLIDE (90% purity)<br>ORCANOX<br>1 kg|1.4987 kg|| |2<br>TERT - AMYL ALCOHOL|2.64 kg|| |<br>RA concerned may take further necessary action as per above decision of NC.|||
| Case No. | 15 / NC/3/MEET/Feb/202223/21 |
|---|---|
| Case Status | Case Deferred |
| Party Name | AROCHEMA INGREDIENTS PRIVATE LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Feb/ 202223/ 21 and 22/02/2023 |
| HQ File Number | HQRNORM APPLY 00001332AM23 |
| RA File Number | 26AX04000018 AM23 |
| Licence No and<br>Date | 2611000615/13/06/2022 |
| Norms Committee Decision: | |
| Shri R. Kumarasamy, VP (Site Operation) and Shri Shivananda Shetty, Head – Finance had attended the Personal | |
| Hearing and explained firm’s case. The Committee after hearing explanation of Representative of the firm decided to | |
| call for following information / documents from the firm: | |
| Chemical name of Export Product.<br>i. | |
| Percentage of molar yield.<br>ii. | |
| Molecular<br>iii. | weight of Export Product and import item No. 1. |
| Step-wise percentage wastage.<br>iv. | |
| COA of Export Product indicating impurity profile of Export Product.<br>v. | |
| COA of import item No. 1 from foreign supplier.<br>vi. |
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vii. Production / Consumption data duly certified by GST. viii. Percentage purity of Export and import item No. 2.
17 This document has been digitally signed by AJAY KUMAR, Deputy Director on 07-03-2023 17:49:40.
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