Pharmaguidances LIQUID INJECTION S.no. GENERIC NAME COMPOSITION REF. CLAIM STRENGTH 1 AmikacinSulphate Injection IP 100 Mg/2ml 250mg/2ml 500mg/2ml Each 2ml contains: AmikacinSulphate Eq. to Amikacin IP 100,250,500 mg Methyl Paraben (As Preservative) IP 0.18% w/v Propyl Paraben (As Preservative) IP 0.02% w/v Water For Injection IP q.s. 2 Aceclofenac Injection Each ml contains: … Read more
DRY INJECTION (HUMAN) S.NO GENERIC NAME COMPOSITION REF. CLAIM STREN. 1 Acyclovir Intravenous Infusion IP (250 mg)(500mg) Each Vial Contains: Acyclovir Sodium (Sterile) Eq. to Anhydrous Acyclovir IP 250 & 500 mg 2 Artesunate Injection IP 60 & 120 &90 &180 Each Vial Contains: Sterile Artesunate IP 60 & 120 &90 &180 mg 3 Amoxycillin … Read more
COPP LIST – Lyophilized Injection S. No Generic Name COPP 1 Voriconazole for Injection 200mg/vial (Lyophilized) 2 Cerebroprotein Hydrolysate for Injection 60mg (Lyophilized) Available 3 Caspofungin Acetate for Injection 70mg (Lyophilized) Available 4 Caspofungin Acetate for Injection 50mg (Lyophilized) Available 5 Vecuronium Bromide for Injection BP 10mg/vial (Lyophilized) Available 6 Pantoprazole for Injection BP … Read more
COPP LIST – Liquid Ampoule Injection S. No Generic Name COPP 1 Diclofenac Sodium Injection 75mg/ml Available 2 Diclofenac Sodium Injection 25mg/ml Available 3 Citicoline Sodium Injection 250mg/ml Available 4 Artemether Injection 40mg/ml Available 5 Artemether Injection 80mg/ml Available 6 Atracurium Besylate Injection USP 25mg/2.5ml Available 7 Atracurium Besylate Injection USP 50mg/5ml Available 8 Clindamycin … Read more
COPP LIST – Liquid Vial Injection S.No Generic Name COPP 35. Amikacin Sulfate Injection USP 500mg/2ml Available 36. Lidocaine Injection USP 20mg/ml Available 37. Amikacin Sulfate Injection USP 100mg/2ml Available 38. Amikacin Sulfate Injection USP 250mg/2ml Available 39. Ascorbic Acid Injection USP 250mg/ml Available 40. Rocuronium Bromide Injection 50mg/5ml Available 41. Dexamethasone Injection USP 4mg/ml … Read more
COPP LIST – Dry Powder for Injection S.No Generic Name COPP 1. Pantoprazole for Injection BP 40mg Available 2. Acyclovir for Injection USP 250mg Available 3. Acyclovir for Injection USP 500mg Available 4. Creatine Phosphate Sodium for Injection (Combipack) Available 5. Teicoplanin for Injection 200mg Available 6. Teicoplanin for Injection 400mg Available 7. Methylprednisolone Sodium … Read more
Pharmaceutical Facility Management A pharmaceutical facility is a GMP-compliant manufacturing, testing, packaging, warehousing, and distribution environment designed to ensure that pharmaceutical products are consistently produced and controlled according to predefined quality standards. The facility must be designed, constructed, qualified, operated, maintained, and monitored to prevent contamination, mix-ups, cross-contamination, and errors while ensuring compliance with regulatory … Read more
Utilities in the Pharmaceutical Industry Utilities are the essential support systems that enable pharmaceutical manufacturing, testing, packaging, and storage operations. Although utilities are not always part of the finished product, they directly impact product quality, patient safety, process reliability, and regulatory compliance. Therefore, pharmaceutical utilities must be designed, qualified, operated, monitored, maintained, and periodically reviewed … Read more
Key Quality Systems in the Pharmaceutical Industry A Pharmaceutical Quality Management System (PQMS) is a comprehensive framework designed to ensure that pharmaceutical products are consistently manufactured, tested, stored, and distributed to meet predefined quality, safety, efficacy, and regulatory requirements. It is based on the principles of ICH Q10 Pharmaceutical Quality System, WHO GMP, EU GMP, … Read more
SOP for Procedure for Assigning New Product Retest Date 1.0 Objective To establish a procedure for assigning or extending the retest date of products based on stability data, ensuring product quality, safety, and compliance with regulatory requirements. 2.0 Scope This SOP is applicable to all finished products manufactured for which retest date assignment or extension … Read more