JB Chemicals and Pharma Panoli facility concludes USFDA inspection no observations

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2025-03-15 08:00 GMT | Update On 2025-03-15 08:00 GMT

Mumbai: JB Chemicals and Pharma has announced that the Company's API manufacturing facility- D9 located at Plot No. 5, GIDC, Panoli, Gujarat has concluded the U.S. Food and Drug Administration (USFDA) inspection with no observations.

The inspection was conducted from March 10, 2025 to March 13, 2025.

At the end of the inspection, the facility received “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 Chemicals stated in a BSE filing.

Established in 1976, J.B. Pharma is a pharmaceutical company headquartered in Mumbai, India. Besides India presence, which accounts for majority of its revenue, its other two home markets are Russia and South Africa. The company exports its finished formulations to over 40 countries including the USA. Besides supplying branded generic formulations to several countries, it also manufactures medicated lozenges. It has eight state 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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JB Chemicals and Pharma Panoli facility concludes USFDA inspection no observations

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