Natco Pharma Vizag facility gets EIR from USFDA

Published On 2023-06-16 08:00 GMT | Update On 2023-06-16 10:46 GMT

Hyderabad: Natco Pharma Limited has announced the successful closure of inspection and received Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA) for its drug formulations manufacturing facility at Visakhapatnam (Vizag), Andhra Pradesh, India.

The USFDA had inspected the facility from 30th January to 3rd February 2023 and issued two observations, one on written production process control procedure and the other on investigation procedure.

Medical Dialogues team has recently reported that the company has received final approval for its Abbreviated New Drug Application (ANDA) for Tipiracil Hydrochloride and Trifluridine Tablets (generic for Lonsurf) from the U.S. Food and Drug Administration (USFDA).

Natco Pharma Limited is a vertically integrated and R&D focused pharmaceutical company engaged in developing, manufacturing and marketing of finished dosage formulations (“FDF”) and active pharmaceutical ingredients (“APIs”). The company's focus is primarily on niche therapeutic areas and complex products. It markets and distributes products in over 40 countries. It sells FDF products in the United States, India, Europe and the rest of the world (“RoW”). Natco also operates in certain key geographies through its subsidiaries.

Natco Pharma is also engaged in contract manufacturing business, whereby it undertakes selected contracts with pharmaceutical companies to manufacture and supply pharmaceutical products.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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Natco Pharma Vizag facility gets EIR from USFDA

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