We offer this product from the manufacturer in India involved in the manufacturing and development of a wide range of high-quality APIs and its advance intermediates through continuous research and development following the latest GMP standards. The facility is WHO-GMP Certified.
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We offer from our manufacturer principals facility located in India with the SOP driven manufacturing activity carried out strictly as per ICH Q7 cGMP guidelines, and several conventional and modern techniques are used for the isolation, semi-synthesis, and purification of our products. The manufacturing processes have been validated to ensure consistent product quality. Facilities have been inspected and approved by Regulatory authorities like US FDA, ANSM, KFDA, TGA, CDSCO, etc. They hold GMP certificates and Written Confirmation for most of our products. They have PMDA accreditation for several products
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We are offering the product from our Indian manufacturer's USFDA, Japan PMDA, Korea FDA approved site. Their facility is COFEPRIS inspected for several products. Their R&D facility is recognized by the Department of Scientific and Industrial Research (DSIR, Ministry of Science and Technology, Government of India).
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We are offering the product from our Indian manufacturer's USFDA, Japan PMDA, Korea FDA approved site. Their facility is COFEPRIS inspected for several products. Their R&D facility is recognized by the Department of Scientific and Industrial Research (DSIR, Ministry of Science and Technology, Government of India).
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We offer this product from the API manufacturing facility located in India consisting of different volumes of reactors suitable to carry the reactions like Catalytic hydrogenations, Chlorination?s, Nitration?s, Alkylation?s, Oxidations, Reductions, Resolutions(chemical), Couplings, etc. The manufacturing unit has a well-equipped ceanroom facility for finished product drying, milling, packing & storage. Quality Control is independent of production and is done in-house at the on-site QC laboratory, including GC & HPLC. Documentations are prepared and upgraded as per GMP guidelines like ICH Q7 and other international regulatory guidelines. Regular Internal Quality Audits and GMP Audits to ensure the continuous maintenance of Change control, Document control, Deviation Handling, Complaint handling, Validation Qualification of Equipment, and total Quality system. The unit has an excellent laboratory to conduct experiments on existing products and other new molecules development.