DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)2.1.2 GENERAL REQUIREMENTS FOR ABRIDGED EVALUATIONNo.Step I: Product Validation1. Product Name2. Dosage Form3.4.Active Ingredient(s)a) Active Ingredient nameb) Strength of Active Ingredient (Quantity unit per dose)c) Source of Active Ingredient (Animal – e.g. Bovine, Porcine, Ovine orOthers/ Plant/ Others)d) Form of Active Ingrediente) Remarks (if any)Excipient(s)a) Excipient nameb) Strength of Excipient (Quantity unit per dose)c) Function of excipient (e.g. absorbent, diluents, bulking agent, coatingagent, anti-caking agent etc.)d) Source of excipiente) Remarks (if any)5.Is there any source of ingredients derived from animal origin, includingactive ingredient? (Yes/ No)6. Manufacturer (Name and Address)7. Is the selected manufacturer a contract manufacturer? (Yes/ No)8.9.Is the product from second source? (Yes/ No)If yes, please provide:a) Letter of declaration stating that this product is a second sourceproductb) Registration number and product name of the first sourceIs this product containing any premix? (Yes/ No)a) State your premix formb) Manufacturer namec) Manufacturer addressd) Certificate of Good Manufacturing Practice (GMP)e) Formulationf) Manufacturing Processg) Specification of Analysish) Certificate of Analysis (CoA)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 146
Drug Registration Guidance Document (<strong>DRGD</strong>)No.10.11.Step I: Product ValidationIs this a replacement product? (Yes/ No)If yes, please provide:a) Letter of Declaration stating that this product is a replacement productb) Registration number and product name of the replaced productIs there any other manufacturer (repacker)? (Yes/ No)a) Manufacturer (repacker) nameb) Manufacturer (repacker) addressc) Certificate of Good Manufacturing Practice (GMP)d) Packaging Process12. Is this an imported product? (Yes/ No)Step II:No.Section A: Product Particulars1. Product Name2. Product Description3. Dosage Forma) Source of Capsule Shellb) Certificate to verify the source of the capsule shellc) Coloring agent used in capsule shell(Please attach COA of the capsule shell)4. Product Indication/ Usage5. Dose/ Use Instruction6. Contraindication7. Warning and Precautions8. Drug Interaction9. Side Effects/ Adverse reaction10. Signs and Symptoms of Overdose and Treatment11. Storage Condition12. Shelf LifeNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 147
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PART III: NON-CLINICAL DATADrug Reg
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1.2 EXEMPTION FROM PRODUCT REGISTRA
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For product containing Red Yeast Ri
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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