JB Chemicals and Pharma Gujarat facility concludes USFDA inspection with zero observations
Gujarat: Pharma major, J.B. Chemicals & Pharmaceuticals Limited, has recently announced that the US Food and Drug Administration (USFDA) has concluded an inspection at the Company’s formulations manufacturing facility- T20 located at Plot No. 4, GIDC, Panoli, Gujarat, with no observations.
The inspection was conducted from June 5, 2023 to June 9, 2023.
"At the end of the inspection, the facility received “No Observations” and thus NO Form 483 was issued," the company stated in a BSE filing.
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," J.B. Chemicals & Pharma stated.
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Established in 1976, J.B. Pharma, is one of the fastest-growing pharmaceutical companies in India and a leading player in the hypertension segment. 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 a leader in the manufacturing of medicated lozenges. The company ranks among the top 5 manufacturers globally in medicated and herbal lozenges. It has seven 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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