Jubilant Pharmova Limited has announced that its subsidiary, Jubilant Cadista Pharmaceuticals Inc., recently underwent an inspection by the United States Food and Drug Administration (USFDA) at its solid oral formulations facility located in Salisbury, Maryland, USA. The inspection resulted in five observations, with no repeat observations cited.
Key Details:
- Jubilant Cadista plans to submit an appropriate action plan to address these observations within the stipulated time frame set by the USFDA.
- The facility has already ceased manufacturing operations, a decision referenced in the company’s disclosure on April 18, 2024.
- The USFDA’s communication regarding the observations was received on January 16, 2025.
This development is not expected to impact the company’s ongoing operations as the facility is no longer producing products. Jubilant Pharmova emphasized its commitment to maintaining compliance with regulatory standards and addressing the USFDA’s observations promptly.
TOPICS:
Jubilant Pharmova