UFDA bans drugs import from Badrivishal Chemicals
The Dollar Business Bureau
The US Food and Drug Administration (USFDA) has restricted imports of drugs from Pune-based Badrivishal Chemicals & Pharmaceuticals.
The US drug regulator has issued the alert under Import Alert 66-40, which authorises the health regulator "detention without physical examination of drugs from firms which have not met drug GMPs".
The company manufactures active pharmaceutical ingredients and specialty chemicals and exports its drugs to more than 30 countries including US, UK, Germany and France.
Badrivishal Chemicals & Pharmaceuticals’s Pune-based plant is approved by Maharashtra FDA and is spread across an area of over 12,000 square feet.
Another Indian drug major, Zydus Discovery, a research subsidiary of Cadila Healthcare, has also been pulled up by the USFDA for misbranding Saroglitazar, a drug used to treat diabetic dyslipidemia and hypertriglyceridemia in India.
The drug watchdog wrote a letter to the company, underlining that the "broad statements" used by the company as the "world's first" is misleading, and that the company should refrain from violating the legal provisions in the US. It asked the company to respond before January 6, 2017.