Manasa Life Sciences, will supply high-quality Active Pharmaceutical Ingredients (APIs) follows a structured and compliant process to ensure product integrity, regulatory adherence, and customer satisfaction.
We begin with supplier qualification and raw material sourcing, where only vendors meeting stringent quality, GMP, ISO, and regulatory criteria are selected. API manufacturing takes place in GMP-certified facilities using validated processes. Each step is closely monitored to ensure consistency in identity, potency, and purity, with careful control of intermediate stages to detect any deviations or impurities.
The identity of the API is verified using analytical techniques such as NMR and FT-IR, while quantitative assays including HPLC, GC, and Q-NMR are performed to confirm potency. Additionally, impurity profiling, microbial limit assessments, and stability testing are carried out to ensure compliance with pharmacopeial and international regulatory standards. APIs are then packaged in tamper-evident, chemically inert containers under controlled conditions. Storage is maintained at defined temperatures to preserve stability. Each unit is clearly labeled with product information, storage conditions, and retest/expiry dates based on real-time and accelerated stability data.
We provide complete regulatory documentation with every batch, including Certificates of Analysis (CoA), Analytical Test Reports (ATR), MSDS supporting full traceability and regulatory submissions for clients worldwide. All shipments are handled using validated methods with appropriate ambient, refrigerated, or frozen logistics as per product requirements. Real-time temperature monitoring ensures that each delivery arrives safely and maintains quality during transit.
Even after delivery, our after-sales support and retest policy ensures continued quality. Batches assigned with a retest date are periodically re-evaluated using validated methods, and updated COAs are provided if needed. No product is released beyond its retest or expiry date without verification.
This end-to-end system ensures our clients receive APIs that are consistent, compliant, and ready for safe pharmaceutical use.