DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)[4] ExcipientPlease refer Appendix 8.2 List of Prohibited and Restricted Excipients; andAppendix 8.3 Lists of Permitted and Restricted Colouring Agents.Details are as for [3] Active Ingredients stated above.Please enter function of excipients, e.g. sweetener, preservative,thickening agent, etc. which can be selected from the drop-down list.[5] Any Animal OriginClick the appropriate button „Yes‟ or „No‟.[6] ManufacturerDefinition of Manufacturer: A company that carries out at least one stepof production as well as the final release of the finished product.Click button „click here to search‟ to select manufacturer listed in thedatabase. For a new manufacturer which is not listed in the databasesearch, please click „Not Listed Manufacturer‟ button. Automatic e-mail willbe send to NPCB for verification.[7] Is The Selected Manufacturer a Contract Manufacturer?Status as to whether the declared manufacturer is a contract manufactureror otherwise, has to be entered. Click the appropriate button „Yes‟ or „No‟.[8] Is This Product Second Source?Click the appropriate button „Yes‟ or „No‟.If yes, please attach letter of declaration stating that this product is asecond source product; and provide registration number and productname of the first source.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 441