THE US drug regulator, Foods and Drugs Administration (FDA), has cleared Lupinâ€™s manufacturing plant in Mandideep (Madhya Pradesh) allowing it to start selling new products made at the plant to the US, the worldâ€™s largest drug market.
The company has also got clean chit for two of its two manufacturing facilities located in Aurangabad and Indore (oral solids and oral contraceptives) following a recent inspection by officials of the American drug regulator, the company said.
"We have received official communication from the USFDA on the satisfactory resolution of the warning letter issued earlier to its Mandideep site in May 2009, â€œLupin said in a release, adding the facility was reinspected in November 2009. While Lupin could continue to sell its drug made at the plant, the FDA stops approval of new drugs once a warning letter is issued. The plant has also got approval from both the UK and Australian drug regulators.
While no deficiencies was noted in the Aurangabad plant, FDA pointed out one deviation in the Indore plant, which was addressed before the close of the inspection, allowing the company to launch liquids and oral contraceptives in the US, it added.
The companyâ€™s share price at the Bombay Stock Exchange closed at 1,420, up 0.4%.
Nilesh Gupta, group president and executive director, Lupin, said that the Mandideep plant was an overhanging issue in the investors mind. The company plans to seek drug approval for about 30-35 new drugs in the US, one-third of which would Para IV application, which gives six-month marketing exclusivity.
Hemant Bakhru, pharma analyst at CLSA said the clearance is a positive development for the company given the problems faced by some Indian companies in the recent past. â€œMandideep used to contribute one-third of its US sales, including its best selling brand Suprax,â€ he added.
A few Indian companies have been hit by regulatory problems in the US. While Ranbaxy is facing a ban on importing products from a couple of its Indian facilities after it failed to addressed deviations noted by FDA in its warning letter, the regulator has also stopped manufacturing at one of Sun Pharmaâ€™s plant in the US.
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