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Wockhardt hopeful of early resolution of USFDA row

Last Updated: Friday, May 29, 2015, 16:25

The company has now increased its R&D spend and filed more ANDAs in the US and Britain for approvals.

Glenmark gets USFDA nod for generic diabetes treatment drug

Last Updated: Friday, May 29, 2015, 12:49

Shares of Glenmark Pharmaceuticals were trading at Rs 874.75 per scrip in afternoon trade, up 2.04 percent from the previous close on the BSE.

USFDA completes Waluj facility inspection: Wockhardt

Last Updated: Wednesday, May 27, 2015, 20:59

Drug firm Wockhardt, which has been under the USFDA's scanner, Wednesday said that the American health regulator has completed the inspection of its Waluj facility in Maharashtra.

Glenmark gets tentative USFDA nod to sell Rufinamide

Last Updated: Thursday, May 21, 2015, 12:54

Rufinamide is used to treat seizures caused by Lennox-Gastaut syndrome.

Complaint against Sun Pharma for anti-trust violations in US

Last Updated: Friday, May 15, 2015, 17:42

Ranbaxy Laboratories, recently acquired by Sunpharma, has been sued in the US District Court in Massachusetts for allegedly manipulating USFDA rules.

Wockhardt recalls 93K bottles of Captopril tablets from US

Last Updated: Thursday, May 14, 2015, 17:40

Recall has been initiated as the tablets failed to meet tablet/capsule specifications given by the USFDA.

Glenmark gets tentative USFDA nod for generic psoriasis cream

Last Updated: Monday, May 4, 2015, 13:32

The product is the therapeutic equivalent of Danish pharma firm Leo Pharma A/S Dovonex's topical cream of the same strength.

Wockhardt recalls 13 drugs in US after FDA concerns

Last Updated: Tuesday, April 28, 2015, 10:37

Pharmaceuticals major Wockhardt is recalling 13 drugs in the US, manufactured at its two units at Chikalthana and Waluj in Maharashtra, which were under import restrictions from the USFDA.

Claris gets USFDA supplemental nod for Fluconazole injection

Last Updated: Tuesday, April 21, 2015, 13:53

"The company has received the supplemental Abbreviated New Drug Application (ANDA) for Fluconazole injection in the US," Claris Lifesciences said in a filing to the BSE.

Aurobindo gets USFDA nod to sell antibiotic oral suspension

Last Updated: Wednesday, April 15, 2015, 13:04

The approval by the USFDA is for strengths of 100 mg/5 ml and 200 mg/5 ml and the product is ready for launch, Aurobindo Pharma said in a statement.

Aurobindo gets USFDA nod for Atracurium Besylate injections

Last Updated: Thursday, April 9, 2015, 14:12

Drug major Aurobindo Pharma has received final approval from the US health regulator to manufacture and market Atracurium Besylate injections in the American market.

Glenmark gets USFDA nod for post-menopause osteoporosis drug

Last Updated: Tuesday, April 7, 2015, 12:11

The approval for sale of Norethindrone Acetate and Ethinyl Estradiol tablets was given to Glenmark Generics Inc USA, a subsidiary of Glenmark Generics Ltd.