Akums Drugs & Pharmaceuticals announces that its Sterile Manufacturing Plant has received the Good Manufacturing Practice (GMP) Certificate from ANVISA, the Brazilian Health Regulatory Agency.
ANVISA certifications are recognised globally and reflect adherence to the standards of product quality, safety, and compliance. ANVISA’s approval of Akums’ facility, affirms that the site has been inspected, monitored, and found compliant with Brazilian legislation and World Health Organization (WHO) recommendations on Good Manufacturing Practices.
Located in Haridwar, Uttarakhand, Akums’ facility is dedicated to the manufacturing of sterile dosage forms. This certification validates the plant’s 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.
Through this certification, 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.