Delhi, India--(Newsfile Corp. - August 21, 2025) - Akums Drugs & Pharmaceuticals Ltd., India's largest contract development and manufacturing organization (CDMO), proudly announces that its Sterile Manufacturing Plant has been granted the prestigious Good Manufacturing Practices (GMP) certification by ANVISA, the Brazilian Health Regulatory Agency. This certification is a significant global milestone, enabling Akums to enhance its footprint in Brazil and other regulated markets across Latin America and Asia. As ANVISA is a key member of the Pharmaceutical Inspection Co-operation Scheme (PICS), the certification also opens opportunities in other PICS-recognized countries.

Akums manufacturing unit at Haridwar

ANVISA's GMP certification is among the most stringent in the world and reflects adherence to globally harmonized standards of quality, safety, and compliance. The certification confirms that Akums' sterile facility in Haridwar, India, complies with Brazilian legislation and WHO-recommended Good Manufacturing Practices. The plant is now authorized to manufacture and export a broad range of sterile products to Brazil, supporting local partners with end-to-end solutions from manufacturing to commercialization.

The certified facility specializes in the production of aseptically processed powders for sterile penicillin formulations, terminally sterilized large volume parenteral (LVP) solutions, small volume parenteral (SVP) solutions, aseptically processed injectable products, ophthalmic formulations (eye drops), and nasal sprays. Built with advanced infrastructure and quality systems, the facility operates under cleanroom environments with stringent in-process controls and real-time batch monitoring, ensuring consistent delivery of safe and effective products.

This certification aligns with Akums' broader global expansion strategy to enter highly regulated markets and support pharmaceutical companies looking to scale their sterile portfolios. Brazil, being the largest pharmaceutical market in Latin America, presents significant opportunities. The sterile injectable contract manufacturing market in Brazil is projected to grow from $574 million in 2024 to $1.04 billion by 2030. Within this, sterile penicillins, LVPs, and SVPs represent a large addressable opportunity, with Brazil's estimated LVP market size expected to reach $1.2-1.5 billion by 2030, and SVPs contributing hundreds of millions in potential revenue annually.

Commenting on this achievement, Mr. Sanjeev Jain, Managing Director - Akums, said, "We are honored to receive the ANVISA GMP certification for our manufacturing Plant. Our sterile manufacturing capabilities are 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 aim to empower partners with scalable, reliable, and high-quality manufacturing solutions. This certification will further strengthen our collaborations in injectables, penicillin-based products, ophthalmics, and more."

Akums Drugs & Pharmaceuticals Ltd. has long established itself as a trusted Contract Development and Manufacturing Organization (CDMO), offering more than 4100 commercialized formulations across 60+ dosage forms and therapeutic areas. The company's ability to provide end-to-end pharmaceutical solutions—from R&D and product development to large-scale manufacturing and regulatory support—makes it a preferred partner for both Indian and global clients. The ANVISA certification adds to a growing list of global regulatory approvals that Akums has received over the years. As the demand for sterile products grows globally—especially in critical care, ophthalmology, and injectable therapeutics—Akums is well-positioned to serve this market with robust infrastructure and regulatory compliance.

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