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Concord Biotech Clears EU GMP Inspection at Dholka Facility, Strengthens Global API Credentials

Updated: July 18, 2025 13:12

Image Source: Business Upturn
Concord Biotech Ltd has successfully completed its third EU Good Manufacturing Practices (GMP) inspection at its Dholka-based API manufacturing facility in Gujarat. The inspection, conducted by the Government of Upper Bavaria–Central Medicines Control Bavaria, concluded without any critical observations, reaffirming Concord’s compliance with stringent European regulatory standards.
 
Key Highlights:
  • The Dholka facility, operational since 2000, specializes in fermentation-based Active Pharmaceutical Ingredients (APIs) and has a total installed capacity of 450 m³.
  • The inspection marks Concord’s continued alignment with global quality benchmarks, following previous approvals from USFDA, PMDA Japan, and Korea’s MFDS.
  • The facility manufactures APIs across immunosuppressants, oncology, anti-infectives, and anti-fungal segments, with exports to over 70 countries.
Strategic Context:
  • Concord Biotech is among the few global players with scaled fermentation-based API capabilities, supported by strong R&D and backward integration.
  • The company has three manufacturing units—Dholka (API), Valthera (formulations), and Limbasi (API)—with zero discharge infrastructure and flexible plant configurations.
  • The successful EU GMP audit enhances Concord’s ability to expand in regulated markets, particularly Europe, and supports its CRAMS and formulation businesses.
Market Outlook:
  • Analysts expect the inspection outcome to boost Concord’s licensing opportunities and accelerate ANDA filings for its formulations.
  • The company’s consistent regulatory track record and diversified customer base position it as a trusted partner in global pharma supply chains.
Sources: Concord Biotech Corporate Filings, Business Standard, Indian Pharma Post, Business Upturn, Concord Biotech Investor Presentation (July 2025)

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