Hormonal Plant receives EAEU GMP certification
Akums Drugs & Pharmaceuticals has announced that its hormonal manufacturing plant has been granted Good Manufacturing Practice (GMP) Certification by the Eurasian Economic Union (EAEU). This certification enables the company to expand its presence in regulated international markets and enhances its credibility in manufacturing.
The approval covers the manufacturing of hormonal tablets for oral use. These formulations are widely used in therapeutic areas such as women’s health and endocrinology. These formulations include commonly prescribed categories such as combined oral contraceptive pills, progestin-only pills, hormone replacement therapy (HRT) tablets etc, addressing conditions ranging from contraception and menstrual regulation to management of hormonal deficiencies and menopausal symptoms. This enables Akums to serve this segment of healthcare requirements in EAEU markets with standardised and compliant products.
With this certification, Akums’ products are eligible for acceptance across all five EAEU member states: Russia, Belarus, Kazakhstan, Armenia, and Kyrgyzstan. Registrations for selected products are already under process in Russia and Kyrgyzstan, and the company expects to gradually expand its registrations across the other member states.
Sandeep Jain, Managing Director, Akums said, Securing the EAEU GMP certification for our Hormonal plant is a development as demand for hormonal therapies continues to rise in this region. Our strength lies in combining large-scale manufacturing capacity with consistent high-quality standards. This certification enables us to participate in that growth responsibly, by offering standardised and compliant hormonal formulations across the EAEU bloc. We see this as a strong platform to deepen partnerships and expand access to essential therapies in markets representing more than 180 million people.