Akums Drugs & Pharma Hormonal manufacturing plant gets EAEU GMP Certification
New Delhi: Akums Drugs & Pharmaceuticals Ltd. has announced that its Hormonal Manufacturing Plant has been granted Good Manufacturing Practice (GMP) Certification by the Eurasian Economic Union (EAEU).
The demand for hormonal therapies is steadily rising across the EAEU region. Russia, the largest market in the bloc, recorded contraceptive sales of over USD 200 million in the first half of 2024, reflecting consistent demand for regulated oral hormonal products. Analysts also report a 6% CAGR forecast for hormone replacement therapy in Russia from 2024 to 2029, with menopause-care treatments expected to grow at over 5.5% CAGR between 2025 and 2030.
This growth is driven by multiple factors, including increased awareness of reproductive health, government-led healthcare reforms, and a shift toward modern family-planning methods. With the EAEU representing a population of over 180 million, opportunities are significant for companies able to ensure reliable, affordable, and compliant supply. Akums, with its newly secured GMP certification, is positioned to meet this demand across oral hormonal dosage forms.
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. The enables Akums to serve this segment of healthcare requirements in EAEU markets with standardized 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.
In India, the Drugs & Cosmetics Act, 1940 and its Schedule M regulations mandate separate, dedicated facilities for the manufacture of hormonal preparations, recognizing their potency and the risks of cross-contamination. Akums has complied with these requirements since 2010, operating a fully dedicated hormonal plant with independent HVAC, air handling, and personnel flow systems.
According to the company, the EAEU GMP certification strengthens Akums’ scope to engage in both contract manufacturing (CDMO) collaborations and direct supply arrangements. The certification does not limit the company to a single model, giving flexibility to its partners and clients.
Commenting on the development, 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 standardized 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.
