The US arm of Aurobindo Pharma is recalling 47,040 bottles of Venlafaxine Hydrochloride extended release capsules, manufactured by the Hyderabad-based firm, from the American market.
The company didn‘t explain the nature of these observations. Miryalaguda plant was one among the three plants for which the company got US drug regulator warning letter in November 2015.
Glenmark Pharmaceuticals today said it has received four observations from the US health regulator for its Ankleshwar facility after inspection in December 2016.
Marksans Pharma, on February 20, announced that it has successfully completed UK MHRA inspection for its Goa facility without any critical observations. The company is now awaiting further instruction from the agency on the way forward
Biocon shares gained 2.6 percent to hit a record high of Rs 1,123 after the US health regulator USFDA has accepted pharma major Mylan's biologics licence application (BLA) for MYL-1401H, a proposed biosimilar Pegfilgrastim.
Drug firm Zydus Cadila has received approval from the US health regulator to market fluconazole tablets used for the treatment of fungal infections.
Brokerage firms and analysts tracking the stock welcomed the development and most have raised the target price. To be sure a lot of them were expecting resolution of the warning letter on Moraiya facility in the fourth quarter of FY17.
Biocon Thursday announced the US Food and Drug Administration has accepted Mylan‘s Biologics License Application (BLA) for biosimilar chemotherapy drug Pegfilgrastim for review. Sharing details on the development with CNBC-TV18 Biocon Chairperson and Managing Director Kiran Mazumdar Shaw said, "This is a very important acceptance."
The company said it did not receive any observations from USFDA for its Moraiya facility, indicating successful resolution of the warning letter and thereby expects major boost to its US business.
"United States Food and Drug Administration (USFDA) inspected company's Moraiya facility from February 6, 2017 to February 15, 2017. At the end of the inspection no observation (483) is issued," Cadila Healthcare said in a filing to BSE.
Halol is an important plant for Sun Pharma and contributed 10-15 percent to its US sales before the factory received a warning letter from the US Food & Drug Administration for violation of manufacturing norms in December 2015.
During his campaign, US president Donald Trump vowed to ease the burden of the healthcare industry in US by reducing taxes and government regulations. Two important decisions expected from the Trump administration is appointment of Food and Drug Administration (FDA) commissioner and drug price control.
Drug firm Divis Laboratories today reported a 8.73 per cent rise in standalone net profit to Rs 268.32 crore for the quarter ended December 31, 2016.
Pharma major Lupin today said it has received final approval from the US health regulator to market its generic version of Mylan's triamcinolone acetonide cream used for treatment of skin disease.
Pharma firm Strides Shasun Limited today announced that its subsidiary Strides Pharma Global Pte Limited, Singapore has received tentative approval from the United States Food & Drug Administration (USFDA) for its Para IV filing of Fingolimod capsules.
"The company's Bavla facility was successfully inspected by the USFDA in July, 2016, which was intimated to the stock exchanges on July 9, 2016. In this regard, the company has received the Establishment Inspection Report (EIR) from the USFDA for this facility on February 1, 2017," Dishman Pharma said in a regulatory filing.
The company has received the Establishment Inspection Report (EIR) from the United States Food & Drug Administration (USFDA) for its Bavla facility on February 01.
The United States Food and Drug Administration (USFDA) had inspected the Kothur formulation facility between January 16-24, 2017, Natco Pharma said in a BSE filing.
The inspection was conducted by United State Food & Drug Administration (USFDA) at its pharmaceutical formulations facility in Kothur, near Hyderabad, between January 16-24, 2017.
The company Wednesday received the US Food and Drug Administration (USFDA) approval for an anti-migraine drug for which it had filed the Abbreviated New Drug Application (ANDA) in 2012.
US FDA gave a clearance to the company's drug Rizatripan Bonzoate tablet, which is used to treat symptoms due to migraine.
"Some of the IT outsourcing companies right now are looking attractive because the stocks have taken a hit as Trump spoke negatively about immigration in the US," Heather Brilliant, Chief Executive Officer, Morningstar Australasia said.
The company said it has launched the morphine sulfate ER Tablets in strengths of 15 mg, 30 mg, 60 mg, 100 mg and 200 mg having received an approval from the US Food and Drug Administration (USFDA).
The company has launches Morphine Sulfate ER tablets 15 mg, 30 mg, 60 mg, 100 mg and 200 mg having received an approval from United State Food and Drug Administration (USFDA).
US Food and Drug Administration (USFDA) will re-audit three manufacturing facilities of Dr Reddy's Laboratories in the current quarter.