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File No. 4-01/2015-DC (Misc. 63) Directorate General of Health Services Office of Drugs Controller General (India) FDC Division

To,

FDA Bhawan, Kotla Road New Delhi-110002 Dated: , 07 JAN 2016

All State Licensing Authorities, Subject: Manufacturing and Marketing of Unapproved Drug, VitaminK2-7. Regarding. .

Sir,

manufacturingPlease refer to this office letter no. 12-50/12-DC dated: 04.06.2015 regarding informed and marketing of unapproved drug, Vitamin K2-7 whereby it was may that Vitamin K2-7 is not approved for marketing in the country. In this regard, it has be informed that based on the recommendations of Expert Committee,this office bulk approved various formulations containing Vitamin K2-7. Therefore, Vitamin K2-7 drug (API) can be considered as deemed to be approved for the Purpose and the aforesaid letter dated: 04.06.2014 5 issued by this. office may be dealt accordingly. This is for information and necessary action.

Youfg faithfully, (Dr. @. N. Singh) Drugs Controller G&neral (india)

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Copy All to: zonal, Sub Zonal offices of CDSCO

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