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Health See other Health Articles Title: FDA seizes Sun Pharma arm drugs HYDERABAD: In a major shocker for the Rs 4,300-crore Sun Pharma, US Food and Drug Administration (USFDA) seized the entire stock of drugs manufactured by its US subsidiary Caraco Pharmaceutical Laboratories at its Michigan facilities in Detroit on Thursday for "repeated manufacturing standards violations''. The news sent shares of the company plunging to their biggest intra-day low of Rs 1,070, a steep 18% drop on BSE on Friday, before closing at Rs 1,140 or 12% lower than Thursday's close of Rs 1,298. On Thursday, the USFDA action also sent Caraco shares plunging 43% at $2.39 on the American Stock Exchange. According to reports, US officials had on Thursday seized all medicines made at Caraco Pharmaceutical's manufacturing plant in Michigan, which makes 35 drugs, including generic versions of anti-diabetes, analgesics, anti-hypertensives, cardiovascular and psychiatric drugs. Caraco also has two packaging plants in Michigan. This action follows Caraco's continued failure to meet FDA's current Good Manufacturing Practice (GMP) requirements, which ensure quality of manufactured drugs. Through this seizure, the FDA seeks to immediately stop the firm from further distributing drugs until there is assurance that the firm complies with good manufacturing requirements, the USFDA said in a statement. According to reports, USFDA inspectors found poor control of raw materials, higher-than-normal variability in tablet manufacturing processes and poor decisions made by the company's management who are responsible for the quality of drugs being manufactured. Even as a Caraco release issued in Detroit has pegged the value of drugs seized by USFDA in the range of $15-20 million, a Sun Pharma spokesperson stated that the USFDA crackdown would impact the company's consolidated financials to a certain extent. However, Sun Pharma officials claimed the move would not have any impact on the company's manufacturing facilities as Sun Pharma had been getting USFDA approvals during the same time that Caraco's facilities have been in difficulty with US authorities. Sun Pharma will support all of Caraco's efforts to work closely with USFDA to resolve all the GMP requirements as prescribed by the US drug authorities, the Sun Pharma spokesperson said. Sun Pharma acquired a majority stake in Caraco in 1997 and currently holds 76% stake with nearly four out of Caraco's nine directors having affiliations with the former. Interestingly, of Caraco's nearly $337-million turnover, nearly $225 million comes from distributing Sun Pharma products in the US and the remaining $112 million from the sale of its own products. Also Sun Pharma and its units supply Caraco with raw materials and formulations, assist in acquiring machinery and equipment to enhance production capacities, and provide workforce assistance. The latest US crackdown is just one among a series of actions taken against Caraco, which, reports suggest, had earlier this year had been forced to recall the entire production of its brand Digoxin used to treat heart failure and abnormal heart rhythm as well as withdraw several batches of generic metformin hydrochloride tablets used to treat diabetes.
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#1. To: DeaconBenjamin (#0)
Let's see. This company makes drugs that could kill people because they're manufactured out of tolerance one way or the other. I'd just love to see a photograph of the work force along with resumes and criminal checks from all of them. I'd be willing to bet that it looks like a foreign country.
Law Enforcement Against Prohibition
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