February 26, 2015 16:40 (IST)
Glenmark Pharmaceuticals on Thursday announced receipt of approval from the US Food and Drug Administration (FDA) to sell its generic version of AbbVie Inc's blood pressure drug Tarka in the American market.
February 26, 2015 16:36 (IST)
Shares in Wockhardt Ltd fell as much as 5.3 per cent on Thursday after the drug maker said the US Food and Drug Administration (FDA) had raised fresh concerns about a plant already banned from exporting to the United States over quality issues.
February 25, 2015 23:06 (IST)
Pharma major Lupin has tied up with Acceliant to use the Bangalore-based firm's platform in its drug research programmes.
February 25, 2015 17:08 (IST)
The development comes after two members of the United States Congress wrote to the company requesting information and expressing "concern" over the "escalating prices" of two products -- divalproex sodium ER and pravastatin sodium -- marketed by it in the United States.
February 25, 2015 14:26 (IST)
Glenmark Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for generic Ashlyna contraceptive tablets and launched them in the American market.
February 24, 2015 18:56 (IST)
The company has received final approval from US Food and Drug Administration for its abbreviated new drug application for Irbesartan tablets in the strengths of 75 mg, 150 mg, 300 mg and for chewable Cetirizine Hydrochloride tablets in the strengths of 5 mg and 10 mg, Jubilant Life Sciences said.
February 23, 2015 19:46 (IST)
The 750 mg tablets in 60-count bottles, were manufactured by Sun Pharmaceutical Industries at Halol.
February 18, 2015 21:04 (IST)
The company is also seeking shareholders' approval via postal ballot to re-appoint Habil Khorakiwala as chairman of the company for a tenure of five years with effect from March 1, 2015 to February 29, 2020
February 18, 2015 18:11 (IST)
Lupin Pharmaceuticals Inc (LPI), a subsidiary of the company, has launched the all new InspiraChamber anti-static valved holding chamber (VHC) under a strategic licensing agreement with InspiRX Inc, the Mumbai-based firm said in a statement.
February 17, 2015 15:53 (IST)
As per the agreement inked between the two companies, Lupin will be responsible for commercialisation of the product.
February 11, 2015 20:21 (IST)
The company's marketing partner Mylan Inc has filed an abbreviated new drug application (ANDA) for Sorafenib tablets in the strength of 200mg with the US Food and Drug Administration (USFDA), Natco Pharma said in a filing to the BSE on Wednesday.
February 10, 2015 16:02 (IST)
The company has filed Abbreviated New Drug Applications (ANDAs) for Fingolimod, 0.5 mg capsules and Cabazitaxel, 60mg/ 1.5ml injection, with the US Food and Drug Administration, through its respective marketing partners, Natco Pharma said in a filing to the BSE.
February 09, 2015 20:25 (IST)
The initial focus of the JV shall be respiratory and neurology products and it shall also invest in setting up a manufacturing facility in Morocco, it added.
February 04, 2015 16:44 (IST)
Solomon Yimam, Assistant Country Director, US FDA India Office while denying that the inspections are targeted, said the frequency of audits of Indian facilities would depend on the number of product applications filed from that facility.
February 02, 2015 22:00 (IST)
Mylan Inc will acquire certain businesses of Mumbai-based Famy Care Ltd, a specialty women's health care company, for a total consideration of $800 million (over Rs 4,940 crore).
February 02, 2015 21:08 (IST)
The Reserve Bank of India on Monday notified changes in the foreign direct investment (FDI) policy allowing 100 per cent FDI in medical devices segment.
February 02, 2015 15:47 (IST)
The company has received final approval for its Vancomycin Hydrochloride Capsules in strengths of 125 mg and 250 mg from the US Food and Drugs Administration (FDA) to market a generic version of ANI Pharmaceuticals, Inc's Vancocin, Lupin Ltd said in a statement.
February 01, 2015 18:58 (IST)
The company, which is pursuing R&D in both novel biologics as well as biosimilars (generic versions of biologic drugs), in various stages of trials, had spent around Rs 131 crore on R&D in the previous fiscal year which was 6 per cent of biopharma sales.
January 31, 2015 19:13 (IST)
Divis Laboratories Ltd plans to invest Rs 500 crore in Andhra Pradesh to set up its third manufacturing facility as it looks to augment its production capacity.
January 31, 2015 11:52 (IST)
Sun Pharmaceutical Industries Ltd has won US approval to buy Ranbaxy Laboratories Ltd on condition that it will sell its interest in a generic antibacterial medicine, the US Federal Trade Commission said on Friday.