Mac-Chem Products (India)’s Boisar facility renews EU-GMP certification
Drug Approval

Mac-Chem Products (India)’s Boisar facility renews EU-GMP certification

  • By IPP Bureau | April 22, 2024

Mac-Chem Products (India) announced the successful renewal of its European Union Goods Manufacturing Practices (EU-GMP certification) for its manufacturing facility in Boisar. The approval marks a significant milestone for Mac-Chem in its journey of global leadership. The audit was conducted in October 2023 by Swissmedic Swiss Agency for Therapeutic Products.

Speaking on the development, Manish Jain, Director at Mac-Chem said, “We are delighted with the successful renewal of our EU-GMP certification. The achievement affirms our commitment to the highest standards of quality and compliance aligning with the European regulations. The timely approval further reaffirms our commitment for delivering high-quality pharma products that positively impact patient care globally.”

The EU-GMP certification underlines the Boisar facility’s capabilities to ensure consistent and controlled production in accordance with EU quality standards. The facility produces a wide range of APIs, with a special focus on oncology and other niche specialty segments.

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