The USFDA has served import alerts to Canadian drug company Apotex Research's manufacturing facility in Bangalore and Indian firm Micro Labs manufacturing unit in Goa. For both the drug companies, this is their second Indian facility being banned by USFDA.
The spate of import ban on Indian manufacturing units by the USFDA is not stopping. While Sun Pharma may be heaving a sigh of relief as a Credit Suisse report notes that US FDA's Form 483 on Halol plant does not list any observations on data integrity, the US drug regulator has booked two other drug companies for lapses in data integrity and violations of GMP norms, reports CNBC TV18.
The USFDA has served import alerts to Canadian drug company Apotex Research's manufacturing facility in Bangalore and Indian firm Micro Labs manufacturing unit in Goa. For both the drug companies, this is their second Indian facility being banned by USFDA.
Apotex Pharmachem, the other unit of Apotex in Bangalore was banned by USFDA in April 2014, where the USFDA had said the company reported fraudulent data for years. Micro Labs' manufacturing unit in Bangalore was earlier banned in Aug 2013.
Import alert would mean products manufactured at these sites will not be allowed to enter the United States and the firms will not be able to make any generic drug applications from these sites.
The details on the warning letters given to these two companies for the latest import ban have yet not being released by the USFDA. Sources say issues similar to that of its other banned facility were reported here too.
These import alerts bring the spotlight back on the issues of data integrity at Indian manufacturing units and adds to the growing list of facilities being pulled up for these lapses.
Since 2013 USFDA has banned 27 Indian units for violations. This year till now, USFDA has already crackdown on 7 manufacturing units, the big name in the list being Sun Pharma 's Kharkadi plant in Gujarat. 2013 has seen a series of import alerts being served to 20 non-conforming units and involved bigwigs like Ranbaxy , Wockhardt .
And one consistent problem that USFDA has been finding at almost all of the units is that of data integrity, where USFDA has found instances of faking data, incomplete records, retesting to match results. Experts say there is a need for Indian manufacturers to keenly resolve these issues as even other regulators are likely to take a closer look at data integrity, besides GMP, in future.
Ranbaxy Labs stock price
On September 26, 2014, Ranbaxy Laboratories closed at Rs 602.90, up Rs 29.35, or 5.12 percent. The 52-week high of the share was Rs 667.30 and the 52-week low was Rs 306.05.
The company's trailing 12-month (TTM) EPS was at Rs 9.78 per share as per the quarter ended June 2014. The stock's price-to-earnings (P/E) ratio was 61.65. The latest book value of the company is Rs 25.87 per share. At current value, the price-to-book value of the company is 23.30.
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