Strategic Milestone Strengthens Akums’ Global Positioning in Regulated Injectable Markets.

Akums Drugs & Pharmaceuticals Ltd., India’s leading contract manufacturing organisation (CDMO), has received the esteemed Good Manufacturing Practice (GMP) certification from ANVISA, the Brazilian Health Regulatory Agency, for its state-of-the-art Sterile Manufacturing Plant located in Haridwar, Uttarakhand. This certification marks a significant leap in Akums’ ambitions to expand its global footprint, particularly in the Latin American injectables market.

ANVISA is internationally recognised for its stringent regulatory standards. The certification not only affirms Akums’ compliance with Brazilian pharmaceutical regulations but also reflects alignment with WHO GMP guidelines, positioning the company to facilitate high-quality drug production for regulated markets.

Enhancing access to sterile therapeutics

The certified facility is designed specifically for the production of sterile dosage forms, including:

• Aseptically processed powders for penicillins
• Terminally sterilised large volume parenterals (LVPs)
• Terminally sterilised and aseptically processed small volume parenterals (SVPs)

With robust cleanroom operations, strict aseptic protocols, and in-process quality controls, the plant exemplifies Akums’ focus on safety, precision, and scalability. The GMP nod from ANVISA further validates its capability to meet the high expectations of global pharma clients.

Enabling global partnerships and product expansion

The certification enables Akums to support pharmaceutical companies in Brazil and broader Latin America, accelerating product registrations and market entry for sterile injectables in key therapeutic areas, including critical care, ophthalmology, and anti-infectives.

Sanjeev Jain, Managing Director of Akums, stated, “This ANVISA certification reaffirms our global manufacturing standards and opens new avenues for collaboration in regulated markets. Our sterile facility is now recognised for its world-class infrastructure and regulatory compliance, offering confidence to our partners worldwide.”

Sandeep Jain, Joint Managing Director of Akums, added, “We are proud to empower our clients with scalable and compliant manufacturing solutions. This certification strengthens our promise to deliver safe, effective, and globally accepted formulations that meet the evolving needs of international healthcare systems.”

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A trusted CDMO with expanding global recognition

With a portfolio of over 4,100 commercialised formulations across 60+ dosage forms, Akums has built a solid reputation as a trusted CDMO partner. Its comprehensive solutions—ranging from R&D and product development to large-scale manufacturing and regulatory support—make it a preferred choice for pharmaceutical companies in both emerging and developed markets.

The ANVISA GMP certification adds to the growing list of global regulatory approvals secured by Akums and aligns with the company’s long-term strategy of expanding into highly regulated markets. As the demand for sterile products increases, especially post-pandemic, Akums stands ready to meet global requirements with agility, quality, and precision.

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