Akums Drugs and Pharmaceuticals has announced that its sterile manufacturing plant in Haridwar, Uttarakhand, has been awarded the Good Manufacturing Practice (GMP) certificate from ANVISA, the Brazilian health regulatory agency.

This certification marks a significant milestone for Akums as it paves the way for expanding its footprint in Brazil’s pharmaceutical market, particularly in the injectables segment.

ANVISA is recognised among the most stringent and respected regulatory authorities worldwide, and certifications reflect adherence to the highest standards of product quality, safety, and compliance.  

The Haridwar facility, dedicated to the manufacturing of sterile dosage forms, was inspected, rigorously monitored, and found compliant with Brazilian legislation and World Health Organization (WHO) recommendations on Good Manufacturing Practices.

The ANVISA certification validates the plant’s robust capabilities in manufacturing a wide range of sterile dosage forms, including aseptically processed powders for penicillins, terminally sterilised large volume parenteral (LVP) solutions, terminally sterilised small volume parenteral (SVP) solutions, and aseptically processed small volume parenteral solutions.

 “The facility is equipped with progressive technologies and adheres to stringent regulatory processes, ensuring that every product manufactured meets the highest standards of safety, precision, and therapeutic efficacy. From sterile environments and cleanroom protocols to in-process controls and batch release procedures, every element of production is monitored meticulously,” the company noted in a press release.

This certification holds special importance for Akums as it aligns with its broader vision of expanding into regulated markets and delivering world-class manufacturing solutions to global pharmaceutical companies.  

This new global regulatory approval will enable Akums to support its international partners in scaling up production in Brazil and other Latin American countries, enabling timely access to high-quality medicines.

Commenting on the achievement, Sanjeev Jain, Joint Managing Director – Akums, said, "We are honored to receive the ANVISA GMP certification for our manufacturing plant. Our sterile manufacturing capabilities are now globally acknowledged, and we are excited to contribute further to the advancement of healthcare across borders.”

“Importantly, this certification also enables our partners to accelerate product registrations and commercialization in Brazil and other Latin American countries, backed by our regulatory compliance and manufacturing strength,” he added.

Akums Drugs and Pharmaceuticals is a leading Indian Contract Development and Manufacturing Organisation (CDMO), offering more than 4100 commercialised formulations across 60 plus dosage forms and therapeutic areas.