Anuh Pharma Ltd secures Certificate of Suitability (CEP) from EDQM for Sulfadimethoxine API, easing European market entry by confirming compliance with pharmacopoeia standards. This veterinary antibiotic approval bolsters the firm's regulatory portfolio amid ongoing expansions in anti-malarials and beyond.
CEP Victory Explained
The EDQM's CEP certifies that Anuh Pharma's Sulfadimethoxine production meets European Pharmacopoeia monograph requirements, simplifying drug approvals across Europe. As a key veterinary antibiotic, this enhances Anuh's global supply chain credibility, building on prior CEPs for Sulfadoxine and others like Allopurinol.
Key Highlights
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Regulatory Boost: CEP replaces extensive dossiers, accelerating EU registrations for Sulfadimethoxine used in animal health.
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Portfolio Strength: Joins valid CEPs for 10+ APIs including Azithromycin (CEP 2021-143 Rev 02, Nov 2025) and Gliclazide.
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Market Edge: Targets regulated exports; firm holds WHO GMP, COFEPRIS alongside EDQM nods despite past suspensions resolved.
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Strategic Fit: Aligns with anti-malarial focus—Sulfadoxine CEP already approved—driving revenue in Europe, Latin America.
Sources: PharmaCompass, TradeBrains, EquityBulls, EDQM, ICRA Reports