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Dishman Carbogen Amcis Ltd. Announces a Successful FDA Inspection of its Site in Bavla, India

Ahmedabad, India (November 5th, 2018) — India-based Dishman Carbogen Amcis Limited, a global outsourcing partner for the pharmaceutical industry, announced today that its manufacturing and development facility in Bavla has successfully completed an inspection by the U.S. Food and Drug Administration (FDA).

The FDA’s Current Good Manufacturing Practices (CGMP) audit, which is performed to ensure proper design, monitoring and control of manufacturing processes and facilities, was held from October 22-26. The five-day inspection focused on the Active Pharmaceutical Ingredient (API) units and ancillary areas of the Bavla site, specifically the quality system, production and packaging operations. The inspection also included examinations of the warehouses and quality control areas. No critical observations were reported and the final Establishment Inspection Report (EIR) is expected within the next six months.

“I am extremely pleased with the positive outcome of this FDA inspection. It is the result of our ongoing dedication to maintaining high quality standards and continuously meeting our customers’ expectations,” said Mr. J. R. Vyas, Chairman and Founder of the Dishman Carbogen Amcis Group.

“It was especially rewarding for us to hear that the auditor appreciated our Team’s’ open communication and transparent way of working. I am very proud of our staff. Their commitment to excellence every day is the key to our performance and our long track record of successful audits,” said Dr Himani Dhotre, CEO of the DCAL Bavla Site.

The Bavla facility manufactures products according to CGMP standards and is routinely inspected by legal authorities and external customers. The facility underwent successful FDA inspections in 2006, 2012, 2015 and 2016.

In operation since 1996, the Bavla facility is Dishman Carbogen Amcis’ main site and employs more than 900 people. The site also features:

  • Large CMO and CRO capacity (300,000 m2) - 750 qm reactor capacity
  • Kg to multi tonne per annum batch scale
  • Commercial Highly Potent Category 4 API manufacturing
  • FDA approved, Kosher, EDQM, TGA and DCGI/WHO approved
  • Featuring special technologies: Ozonolysis, Irradiation, Spray Drying, Hydrogenation, Chromatography, Peptide Synthesis, Enzyme Technology
  • 13 manufacturing units on site
  • Fully facilitated ADL and R&D labs for development
  • ISO 9001, ISO 13485, ISO 14001 and OHSAS 18001 certification

Dishman Carbogen Amcis Limited is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Carbogen Amcis Group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe and India.

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