FDA has approved Dishman Pharmaceuticals and Chemicals' (Dishman) Naroda facility in India for the manufacturing of Active Pharmaceutical Ingredients (API).
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The FDA had a thorough inspection of the Naroda facility and cleared after it was found to be suitable for manufacturing export-purpose APIs.
The facility is an Export Oriented Unit (EOU) and will manufacture the APIs for the US markets. It was established with the help of Carbogen Amcis and its technical team. Carbogen Amcis is a Swiss subsidiary of Dishman Pharma.
Reportedly, the company is planning to start two new API units with an investment of INR1.25-1.5bn next year. Earlier, Dishman had announced its expansion plan wherein it declared an investment of INR1.25bn capex plan by the end of March this year.
Additionally, the company’s API facility in Ahmedabad, India, manufactures a range of oncology APIs and other related high potency products.
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