Boisar Facility Successfully Renews EU-GMP Certification
Mac-Chem Products Boisar facility successfully renews EU-GMP certification
Overview
Mac-Chem Products (India) Pvt. Ltd. (Mac-Chem) 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.
Words from Mac-Chem
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.
EU-GMP Certification
- 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.
About Mac-Chem
- Mac-Chem Products (India) Pvt. Ltd. (Mac-Chem) is a leading pharmaceutical company with a strong presence in active pharmaceutical ingredients (APIs).
- Headquartered in Mumbai, the company has operations in over 40 countries globally.
- A subsidiary of Naprod Life Sciences, Mac-Chem was established in 2010 to address the uncertainty related to the availability and quality of APIs.
- With over 800 employees, Mac-Chem now has a national and a global footprint with four facilities which hold accreditations from multiple regulatory bodies including the US FDA, EDQM, COFEPRIS, ANVISA, MFDS-Korea, WHO-GMP, Written Confirmation (WC) and ISO.
