We offer this product from the manufacturer in India, having the manufacturing facility approved by the local FDA authority and CDSCO. The facilities are WHO GMP and ISO 9001:2015 certified with quality systems complying with ICH-Q7 guidelines.
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We offer this product from a manufacturer in India specializing in Prescription drugs, Generic, OTC Products, Intravenous infusion, and Bulk Actives with 25years of experience. Both APIs and FDF?s are being manufactured at world-class manufacturing facilities.
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We offer this product from a manufacturer in India who specializes in exploring the untapped potential for Drug Intermediates. With the customer base expanding manifold and demanding more products, the unit grew further with the focus on APIs and the Intermediates. This plant has been designed keeping in view cGMP requirements & 21 CFR norms.
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We offer this product from a manufacturer in India with an ISO 9001 quality management system in a cGMP compliant facility and a strict HACCP program, KOSHER ? Star-K PAREVE status.
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We offer this product from an Indian manufacturer having two-world class manufacturing sites, USFDA and COFEPRIS approved, WHO GMP certified, and have received AFM certificate from Japanese PMDA and recently concluded Korean FDA audit successfully. Further, the facility is also compliant with all other major regulatory bodies, including UKMHRA, EDQM, and TGA.
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We offer this product from an Indian manufacturer having two-world class manufacturing sites, USFDA and COFEPRIS approved, WHO GMP certified, and have received AFM certificate from Japanese PMDA and recently concluded Korean FDA audit successfully. Further, the facility is also compliant with all other major regulatory bodies, including UKMHRA, EDQM, and TGA.
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We offer this product from a manufacturer in India who specializes in exploring the untapped potential for Drug Intermediates. With the customer base expanding manifold and demanding more products, the unit grew further with the focus on APIs and the Intermediates. This plant has been designed keeping in view cGMP requirements & 21 CFR norms.
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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.
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We offer this product from a manufacturer in India led by seasoned, experienced techno-commercial professionals in Ahmadabad, Gujarat (India). With an experienced team of scientists & engineers; GLP compliant labs, and WHO GMP manufacturing plants in Ahmedabad, the factory is suitably placed to quickly supply quality products APIs and Intermediates across the scale and solve our clients? challenging development, scale-up & regulatory needs by offering a broad range of development services.
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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 offer this product from a manufacturer in India who specializes in exploring the untapped potential for Drug Intermediates. With the customer base expanding manifold and demanding more products, the unit grew further with the focus on APIs and the Intermediates. This plant has been designed keeping in view cGMP requirements & 21 CFR norms.
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We offer this product from a manufacturer in India having a global manufacturing footprint that helps us deliver quality-assured products to our customers worldwide. In line with the growth strategy, we continue to ramp up capacities and automation to support the pipeline of complex generics and biotechnology products.
