DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)Additional Information1. Methylene Chloride/ Dichloromethane are not allowed as solvent in filmcoatingonly for locally manufactured products, in order to protect workersduring manufacturing process.2. Alcohol is not allowed unless it is essential to the formulation and no suitablealternatives to alcohol are available. Content of alcohol shall be at theminimum level as possible.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 340
Drug Registration Guidance Document (<strong>DRGD</strong>)8.3 LIST OF PERMITTED AND RESTRICTED COLOURING AGENTS8.3.1 List of Permitted Colouring AgentsNO.COLOURING AGENTSCOLOURINDEXNUMBER (CI)1. Allura Red AC/ FD & C Red No.40 160352. Anthocyaninsa. Those glycosides of 2-phenylbenzopyrylium salts whichare anthocyaninsb. The following anthocyanidin aglycones :i. Pelargonidinii. Cyanidiniii. Peonidiniv. Delphinidinv. Petunidinvi. Malvidin3. Black PN (Brilliant Black BN) 284404. Brilliant Blue FCF 420905. Calcium Carbonate6. Carbo Medicinals/ Vegetalis; (Charcoal)7. Caramel8. Carmoisine (or Azorubine) 147209. Carotenoidsa. Alpha, Beta, Gamma-Caroteneb. Bixin, Noribixin, Roucouc. Annattod. Capsanthin, Capsorubin, (paprika extract)e. Lycopenef. Beta-Apo-8‟ carotenal (C 30)g. Ethyl ester of Beta-Apo-8 Carotenoic Acid (C30)i. Chlorophyllii. Copper complexes of Chlorophyll andChlorophyllins75120408207581010. Chocolate Brown HT 2028511. Cochineal or Carminic Acid, Carmine from Cochineal 7547012. Curcumin 7530013. Fast Green FCF (FD & C Green No.3) 42053National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 341
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PART III: NON-CLINICAL DATADrug Reg
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- All information must be provided
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1.2 EXEMPTION FROM PRODUCT REGISTRA
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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