• 10 Sep 2025
• Admin
• News Article

Akums Secures EAEU GMP Certification for Hormonal Plant

Akums Drugs & Pharmaceuticals has received Good Manufacturing Practice (GMP) certification from the Eurasian Economic Union (EAEU) for its hormonal manufacturing plant. This approval opens doors for Akums to expand in regulated international markets while reinforcing its credibility in high-quality pharmaceutical production.

Rising Demand in the EAEU

• Russia, the bloc’s largest market, reported US$ 200 million in contraceptive sales in the first half of 2024.
• Hormone replacement therapy (HRT) in Russia is projected to grow at a 6% CAGR (2024–2029).
• Menopause-care treatments are expected to expand at 5.5% CAGR (2025–2030).
• Key growth drivers:
  - Greater awareness of reproductive health.
  - Government-led healthcare reforms.
  - Increasing adoption of modern family-planning methods.

With a population of 180 million, the EAEU represents a major opportunity for compliant suppliers of hormonal products.

What the Certification Covers

The approval covers oral hormonal tablets, widely prescribed in:

• Women’s health: contraception, menstrual regulation.
• Endocrinology: hormone deficiencies, menopausal symptom management.
• Key categories include:
  - Combined oral contraceptives.
  - Progestin-only pills.
  - Hormone replacement therapy (HRT) tablets.

This enables Akums to deliver standardized and compliant formulations across EAEU member states.

Market Access Across the Bloc

• Certified products can now be accepted in Russia, Belarus, Kazakhstan, Armenia, and Kyrgyzstan.
• Product registrations are underway in Russia and Kyrgyzstan, with gradual expansion planned across the region.

Compliance Strengths

In India, Schedule M of the Drugs & Cosmetics Act, 1940 mandates dedicated facilities for hormonal manufacturing.

• Akums has operated a fully dedicated hormonal plant since 2010, equipped with:
  - Independent HVAC and air handling systems.
  - Controlled personnel flow systems.

This long-standing compliance track record provided the foundation for securing EAEU certification.

Business Outlook

The certification enhances Akums’ ability to pursue:

• CDMO partnerships with global pharma companies.
• Direct supply arrangements across the EAEU.
• Flexible collaboration models tailored to client needs.

Leadership Insight

Sandeep Jain, Managing Director, Akums:

“This certification enables us to participate in the region’s growing demand responsibly. By combining large-scale manufacturing with high-quality standards, we can deepen partnerships and expand access to essential therapies for over 180 million people.”