DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)2.1.1 GENERAL REQUIREMENTS FOR FULL EVALUATIONNo.1.Step I: Product ValidationIs your product has a brand name? (Yes/ No)(If yes, please provide brand name and product name)2. Dosage Form3.4.5.Active Ingredient(s)a) Active Ingredient Nameb) Strength of Active Ingredient (Quantity unit/ 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/ dose)c) Function of excipient (e.g. absorbent, diluents, bulking agent, coatingagent, anti-caking agent etc.)d) Source of excipiente) Remarks (if any)Is there any source of ingredients derived from animal origin, including activeingredient? (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 source productb) 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 | 138
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:Part I: Administrative Data And Product InformationNo.Section A: Product Particulars1. Product Name2. Name & Strength of Active Substance and Excipient3. Dosage Form4. Product Description5. Pharmacodynamics6. Pharmacokinetics7. Indication8. Recommended Dose9. Route of Administration10. Contraindication11. Warning and Precautions12. Interaction of Other Medicaments13. Pregnancy and Lactation14. Side Effects15. Symptoms and Treatment of OverdoseNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 139
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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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