DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)[9] Does This Product Contain Any Premix?Click the appropriate button „Yes‟ or „No‟.If yes, please provide the following details:i) State your premix formj) Manufacturer namek) Manufacturer addressl) Certificate of Good Manufacturing Practice (GMP)m) Formulationn) Manufacturing Processo) Specification of Analysisp) Certificate of Analysis (CoA)[10] Is This a Replacement Product?Click the appropriate button „Yes‟ or „No‟.If yes, please attach letter of declaration stating that this product is areplacement product; and provide registration number and product nameof the replaced product.[11] Other Manufacturer (Repacker)Click the appropriate button „Yes‟ or „No‟.Please enter name of company and click button „search‟ to select othermanufacturer (repacker) listed in the database. For a new othermanufacturer (repacker) which is not listed in the database search, pleaseclick „Not Listed Manufacturer‟ button. Automatic e-mail will be send toNPCB for verification.Select from processing type drop-down list, e.g. assembly, packing,production, labelling, fill and finish, others.[12] Is This an Imported Product?Click the appropriate button „Yes‟ or „No‟.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 442