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Thursday, August 28, 2025

Unlocking Competitive Edge: How Digital Maturity Empowers CDMOs to Secure More Sponsor Contracts

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In the fast-paced world of contract development and manufacturing organizations (CDMOs), compliance isn't just a box to check—it's a...
Wednesday, August 27, 2025

Final Revised Good Agricultural and Collection Practice (GACP) Guideline Published: What You Need to Know About Revision 1

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**Posted on August 28, 2025** Hello, GMP compliance enthusiasts! If you're involved in the world of herbal medicinal products, you'v...
Monday, August 25, 2025

US FDA WL to Indian pharm company after fire accident

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Access WL The recent FDA warning letter to an Indian manufacturer of active pharmaceutical ingredients (APIs) highlights major Good Manufact...
Monday, August 4, 2025

US FDA Glenmark Pharmaceuticals Limited 2025

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The United States Food and Drug Administration (FDA) issued a warning letter to Glenmark Pharmaceuticals Limited on July 11, 2025, following...
Thursday, July 24, 2025

Test User Reg

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Saturday, July 19, 2025

US FDA 483 Dynamic Blending Specialists, Inc

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A recent FDA inspection at a U.S. drug company—making products like pain relief gels and fluoride toothpaste—has uncovered serious problems ...
Wednesday, July 16, 2025

Analytical Method Performance USP 1221

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The United States Pharmacopeia (USP) General Chapter <1221> Ongoing Procedure Performance Verification, proposed in the Pharmacopeial ...
Sunday, July 13, 2025

Nitrosamine Impurities AI bot

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Friday, July 4, 2025

Gap Assessment Schedule M

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To conduct a **gap assessment** between the **old Schedule M** and the **revised Schedule M** of the **Drugs and Cosmetics Rules, 1945**, we...
Wednesday, July 2, 2025

FDA Issues Warning to Horizon Tool Inc. for Manufacturing Violations

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On June 6, 2025, the U.S. Food and Drug Administration (FDA) sent a stern warning letter to Horizon Tool Inc., a Greensboro, North Carolina-...