USFDA issues 4 observations for Jubilant Generics Roorkee facility
Noida: Jubilant Pharmova Limited has announced that the United States Food and Drug Administration (USFDA) has issued 4 observations at the conclusion of pre-approval inspection (PAI) of the solid dosage formulations facility at Roorkee site, India of Jubilant Generics Limited, a subsidiary of its wholly owned subsidiary Jubilant Pharma Limited.
The inspection was concluded on August 01, 2025.
The USFDA has issued 4 observations pursuant to the completion of audit.
The company will submit an action plan on the observations. The site’s revenue from the US market in the trailing twelve month period (July’24 to June’25) is less than one percent of Jubilant Pharmova revenues in the same period.
Read also: Jubilant Radiopharma business receives ANDA approval for Technetium Sulfur Colloid Injection
Jubilant Pharma Limited (JPL), a Company incorporated under the laws of Singapore and a wholly-owned subsidiary of Jubilant Pharmova Limited, is an integrated global pharmaceutical company engaged in manufacturing and supply of Radiopharmaceuticals with a network of 45 radio-pharmacies in the US, Allergy Immunotherapy, Contract Manufacturing of Sterile Injectables and Non-sterile products and Solid Dosage Formulations through multiple manufacturing facilities that cater to all the regulated market including USA, Europe and other geographies.
Jubilant Pharmova Limited, formerly Jubilant Life Sciences Limited, is a company with a global presence that is involved in Radiopharma, Allergy Immunotherapy, CDMO Sterile Injectables, Contract Research Development and Manufacturing Organisation (CRDMO), Generics and Proprietary Novel Drugs businesses. In the Radiopharma business, the Company is involved in the manufacturing and supply of Radiopharmaceuticals with a network of 45 radiopharmacies in the US.
The Company’s Allergy Immunotherapy business is involved in the manufacturing and supply of allergic extracts and venom products in the US and in some other markets such as Canada, Europe and Australia. Jubilant Pharmova Limited through its CDMO Sterile Injectables business offers manufacturing services including sterile fill and finish injectables (both liquid and lyophilization), full-service ophthalmic offer (liquids, ointments & creams) and ampoules. The CRDMO business of the Company includes the Drug Discovery Services business that provides contract research and development services through two world-class research centers in Bengaluru and Noida in India and one in France. The CDMO-API business that is involved in the manufacturing of Active Pharmaceutical Ingredients.
Jubilant Therapeutics is involved in the Proprietary Novel Drugs business and is an innovative biopharmaceutical company developing breakthrough therapies in the area of oncology and auto-immune disorders. The Company operates multiple manufacturing facilities that cater to all the regulated markets including USA, Europe and other geographies.
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