Jubilant Pharmova Limited’s wholly owned subsidiary Jubilant Pharma Limited, has announced that its subsidiary Jubilant Generics Limited (JGL) has received a communication from the USFDA through which the latter intimated that pursuant to its July-Aug 2022 audit of JGL’s Solid Dosage Manufacturing facility at Roorkee it has determined inspection classification of the facility as “official action indicated”.

The company currently supplies one product to the US market that contributes low- single digit revenue to Jubilant Pharmova revenues.

The company has been continuously cooperating with the USFDA and will undertake all necessary steps to resolve regulatory status at the Roorkee facility.

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 48 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. Jubilant Therapeutics (JTI) invested for in-house Proprietary Novel Drugs business and is an innovative biopharmaceutical company developing breakthrough therapies in the area of oncology and auto-immune disorders.