USFDA classifies Jubilant Pharmova Nanjangud facility as Voluntary Action Indicated

Noida: Jubilant Pharmova Limited has announced that pursuant to the United States Food and Drug Administration (USFDA) inspection of its API manufacturing facility at Nanjangud during 05-13 December 2022, it received a communication from the USFDA through which the regulatory agency assigned the inspection classification of the API facility as “Voluntary Action Indicated (VAI)”.

Based on this inspection and the USFDA VAI classification, this facility is in compliance with regard to current good manufacturing practices (cGMP).

Medical Dialogues team had earlier reported USFDA had issued eight observations pursuant to the completion of the inspection at the company's API manufacturing facility at Nanjangud, India.

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Jubilant Pharmova Limited (formerly Jubilant Life Sciences Limited) is engaged in Radiopharma, Allergy Immunotherapy, CDMO of Sterile Injectable, Generics, Contract Research Development and Manufacturing (CRDMO), and Proprietary Novel Drugs businesses. With a network of 46 radio pharmacies in the US, Jubilant’s Radiopharma business is engaged in manufacturing and supply of Radiopharmaceutical products and services. Its other businesses such as Allergy Immunotherapy, Contract Manufacturing of Sterile Injectables and Non-sterile products, and Generics (Solid Dosage Formulations) caters to major regulated markets (USA, EU, and other geographies) through five manufacturing facilities. The CRDMO segment (through Jubilant Biosys) provides collaborative research and partnership for Drug Discovery through two world-class research centers in India. The company is also involved in the manufacturing of Active Pharmaceutical Products (API) through a US FDA approved facility in Nanjangud, Karnataka.

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