Akums Sterile Plant Gets ANVISA GMP Certification for Manufacturing

Akums Drugs & Pharmaceuticals Ltd., India’s largest contract manufacturing pharmaceutical company, is proud to announce that its Sterile Manufacturing Plant has received the prestigious Good Manufacturing Practice(GMP) Certificate from ANVISA, the Brazilian Health Regulatory Agency.

This positions the company to strengthen its presence in Brazil’s pharmaceutical landscape, particularly in the injectables segment.

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

ANVISA’s approval of Akums' facility is a significant milestone, affirming that the site has been inspected, rigorously monitored, and found compliant with Brazilian legislation and World Health Organization (WHO) recommendations on Good Manufacturing Practices.

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Located in Haridwar, Uttarakhand, Akums state-of-the-art facility is dedicated to the manufacturing of sterile dosage forms. This 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. This certification holds special significance as it aligns with Akums’ broader vision of expanding into regulated markets and delivering world-class manufacturing solutions to global pharmaceutical companies. With this milestone, Akums will be able 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, the Mr. Sanjeev Jain , MD - Akums stated: "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."

Mr. Sandeep Jain, Joint Managing Director – Akums, added: " At Akums, we believe in empowering our partners with scalable, reliable, and compliant manufacturing solutions. ANVISA’s approval of our Plant allows us to further support our clients in reaching patients in highly regulated markets with sterile products that meet the highest safety and efficacy standards."