Akums Drugs & Pharmaceuticals Ltd., India’s largest contract manufacturing pharmaceutical company, has announced that its Sterile Manufacturing Plant in Haridwar, Uttarakhand, has received the prestigious Good Manufacturing Practice (GMP) certification from ANVISA, the Brazilian Health Regulatory Agency. This achievement marks a pivotal step in the company’s expansion into Brazil’s growing pharmaceutical market, particularly in the injectable segment.
ANVISA is recognized as one of the world’s most rigorous and respected health regulatory bodies. Its certification is internationally acknowledged as a symbol of adherence to the highest standards of quality, safety, and regulatory compliance. The approval confirms that Akums’ facility has successfully undergone stringent inspection and monitoring, aligning with Brazilian regulations and World Health Organization (WHO) guidelines for GMP.
The certified facility specializes in the production of sterile dosage forms and is equipped with advanced technologies to support a wide product portfolio. It includes manufacturing capabilities for aseptically processed powders for penicillins, terminally sterilized large volume parenteral (LVP) solutions, terminally sterilized small volume parenteral (SVP) solutions, and aseptically processed SVPs. Every stage of the manufacturing process—from cleanroom operations and in-process controls to final batch release—is meticulously monitored to ensure product safety and therapeutic efficacy.
This milestone reinforces Akums’ strategic vision of expanding its footprint in regulated global markets. With the ANVISA certification, the company is better positioned to support international pharmaceutical partners in scaling production for Brazil and other Latin American regions, facilitating faster access to high-quality sterile medications.
Commenting on the accomplishment, Mr. Sanjeev Jain, Managing Director at Akums, stated, “Receiving ANVISA GMP certification is a proud moment for us. It reflects our unwavering commitment to quality and global standards. This certification not only validates our sterile manufacturing excellence but also enables our partners to expedite product registrations and commercialization in Brazil and beyond.”
Mr. Sandeep Jain, Joint Managing Director, added, “At Akums, we focus on providing scalable, reliable, and compliant manufacturing solutions. ANVISA’s endorsement strengthens our ability to serve clients in highly regulated markets, delivering sterile products that meet stringent quality and efficacy benchmarks.”
Akums has built a strong reputation as a leading Contract Development and Manufacturing Organization (CDMO), offering over 4,100 commercialized formulations across 60+ dosage forms and therapeutic categories. The company provides integrated pharmaceutical solutions, from research and product development to large-scale manufacturing and global regulatory support. With the ANVISA certification joining a growing list of international regulatory approvals, Akums is well-positioned to meet the rising global demand for sterile pharmaceutical products, particularly in critical care, ophthalmology, and injectable therapies.