USFDA successfully completes audit at JB Chemicals and Pharma Gujarat facility

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2025-03-10 05:45 GMT | Update On 2025-03-10 05:45 GMT

USFDA inspection

Mumbai: J.B. Chemicals & Pharmaceuticals Limited has announced that the US Food and Drug Administration (USFDA) has successfully completed an audit with no observations at the Company’s Gujarat formulations manufacturing facility.

The facility was inspected from March 3, 2025 to March 7, 2025.

"We wish to inform the exchange that the Company’s formulations manufacturing facility- T20 located at Plot No. 4, GIDC, Panoli, Gujarat was inspected by the USFDA," JB Chemicals stated in a BSE filing.

The said audit has been successfully completed by the US FDA with “No Observations” and thus NO Form 483 was issued.

An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

"The Company remains committed to producing quality products, embedding a quality culture across the organization and continuously investing in systems, processes & training of its employees so that it can maintain the highest standards of quality and compliance for all its markets," JB added.

J.B. Pharma was established in 1976. Besides its strong India presence, which accounts for majority of its revenue, its other two home markets are Russia and South Africa. In India, the company has six brands among the top 300 IPM brands in the country. The company exports its finished formulations to over 40 countries including the USA. Besides supplying branded generic formulations to several countries, it is also manufactures medicated lozenges. It has eightstate of the art manufacturing facilities in India including a dedicated manufacturing facility for lozenges. The manufacturing facilities are certified by leading regulators across the world.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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USFDA successfully completes audit at JB Chemicals and Pharma Gujarat facility

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