We are pleased to share that Macsen Drugs, a manufacturing unit of Macsen Labs Ltd, has received EU Written Confirmations (WC) for 7 Active Pharmaceutical Ingredients (APIs) currently under manufacturing.
This important milestone strengthens the company’s position as a trusted manufacturer of niche APIs for regulated international markets and reflects its continued focus on quality systems, compliance, and the readiness to serve partners across the world’s most stringent pharmaceutical markets.
The approved products include:
- Methylene Blue BP / EP / USP
- Silver Sulfadiazine USP
- Fluorescein Sodium USP / Ph. Eur.
- Selenium Sulfide BP / USP / Ph. Eur.
- Selenious Acid USP
- Indigotindisulfonate Sodium USP
- Indocyanine Green USP
EU Written Confirmation is issued under EU legislation, verifying that the manufacturing of an API complies with Good Manufacturing Practice (GMP) standards equivalent to those required within the European Union. For pharmaceutical manufacturers and marketers, these confirmations are a prerequisite for supplying APIs into EU-regulated finished dosage form products. Receiving these confirmations enhances the company’s readiness to support customers seeking reliable API sourcing for Europe and other regulated regions.
With decades of expertise in niche API manufacturing, Macsen Drugs has built a strong portfolio in specialty molecules. The products now covered by EU WCs span a range of therapeutic applications — from diagnostic imaging agents such as Fluorescein Sodium and Indocyanine Green, to antimicrobials like Silver Sulfadiazine, and trace-element APIs including Selenium Sulfide and Selenious Acid.
This achievement adds to Macsen’s growing portfolio of international regulatory approvals and certifications, further enabling the company to support global pharmaceutical manufacturers with compliant, high-quality API supply. We remain committed to advancing our regulatory standing and expanding access to our niche API capabilities across regulated markets in Europe, North America, and beyond.