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Ban imposed by USFDA on India’s Laxachem Organics due to GMP noncompliance

The USFDA has banned products of Laxachem Organics, a maker of active pharmaceutical ingredients, from US markets as part of the effort to arrest the Burkholderia cepacia or the B Cepacia infection- a complex group of bacteria resistant to antibiotics. Laxachem issue is the first time where the US regulator has hinted at possible disease outbreak because of an adulterated product from an Indian company.

Laxachem manufactures active pharmaceutical ingredient (API) for repackagers, labelers and wholesale drug distributors, some of which sell API to manufacturing facilities in the United States. The Centre for Disease Control and USFDA have been investigating multistate outbreak of B Cepacia infection from July onwards and in one of the states it found the outbreak was caused due to contaminated Docusate Sodium, an API supplied by Laxachem.

Laxachem's Ahmednagar facility was also placed under the import alert as the company had not allowed the USFDA to inspect its site. Under the US Federal Food, Drug and Cosmetic Act, drugs, including APIs, made at a facility that denies, limits, or delays an FDA inspection are considered adulterated.

Laxachem will remain on import alert until it has been fully inspected by FDA and found to meet US standards. The FDA has also initiated a voluntary recall of Docusate Sodium product by other distributors.



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