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Aparna Pharmaceuticals Secures EUGMP Approval and Launches New R&D Centre

05 Sep 2025
Admin
News Article

Aparna Pharmaceuticals Secures EUGMP Approval and Launches New R&D Centre

Aparna Pharmaceuticals, a leading manufacturer of APIs and advanced intermediates, has announced two milestones:

European Union Good Manufacturing Practice (EUGMP) site approval for its Pydibhimavaram facility in Srikakulam, Andhra Pradesh.
Launch of Aparna Laboratories, a 7,300 sq. ft. R&D centre in Genome Valley, Hyderabad.

These developments highlight the company’s focus on quality, compliance, and innovation.

Regulatory Achievements

EUGMP approval enables Aparna to expand its footprint in European markets.
First Certificate of Suitability (CEP) received for clopidogrel hydrogen sulfate.
Facility already holds approvals from USFDA, WHO-GMP, and CDSCO, aligning operations with multiple global benchmarks.

Facility Overview

Pydibhimavaram site:
- Spread across 40 acres (170,000 sq. mt.).
- Produces ~250 MT/month of APIs and intermediates.
- Covers multiple therapeutic areas.

With EUGMP, the facility strengthens its position as a trusted global manufacturing hub.

Leadership Perspective

Rakesh Reddy, Managing Director, Aparna Pharmaceuticals

“The EUGMP approval and the Genome Valley R&D launch mark significant steps in our journey. These milestones reinforce our global quality alignment and commitment to innovation. With enhanced capabilities, we can accelerate complex molecule development, strengthen regulated market access, and deliver value as a trusted partner worldwide.”

Growth Strategy

Targeting 30% CAGR over the next five years.
Growth to be driven by:
- Expanding product portfolio.
- Strong demand from regulated markets.
- Custom manufacturing collaborations with global healthcare partners.
New R&D centre designed to:
- Support in-house product development.
- Position Aparna as a preferred CDMO partner.
- Accelerate innovation-led solutions for global clients.

Strategic Outlook

With manufacturing scale, global certifications, and new R&D capabilities, Aparna is positioned to:

Strengthen its presence in regulated markets.
Drive innovation in APIs and complex intermediates.
Deliver safe, effective, and affordable healthcare solutions worldwide.