USFDA issues 4 observations for Jubilant Generics Roorkee facility
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-08-02 05:57 GMT | Update On 2025-08-02 05:57 GMT
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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.
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