DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)6. CONTRACT MANUFACTURERContract manufacturer is aplicable when product owner is not the product manufacturer7. SECOND SOURCE INFORMATIONAn application for a second source may be considered where deemed necessary. Thissecond source product shall be the same as the first product in all respects except for thesite of manufacture.8. PRODUCT CONTAINING PREMIXPremixed active ingredient(s) is a combination of two or more active ingredients that arepreviously manufactured by a different manufacturer.Certificate of GMP for manufacturer/ supplier is required for the premixed ingredient(s) informulation. The requirements for GMP are same as in Field 5 as above.9. REPLACEMENT PRODUCTA product registration holder is not allowed to register/ hold two or more products withsimilar formulation (same active ingredient of raw material, strength and dosage form) atany one time unless product variant.Letter of justification for replacement by product holder is required.10. OTHER MANUFACTURERAny manufacturer involved in Assembly, Fill & Finish, Active Ingredients, Packing, Labelingetc.11. IMPORTED PRODUCTSImported product needs to be declared.SECTION A: PRODUCT PARTICULARSProduct Description:State, briefly, visual and physical characteristics of the product, including as in thefollowing Table 8 (where applicable):National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 191