The drug will be manufactured at the group's formulations manufacturing facility at Moraiya in Ahmedabad, it added.
Cadila Healthcare, Dr.Reddy’s, Aurobindo are the companies to watch out for with half of their revenues coming from US.
The company has received approval from the US Food and Drug Administration (USFDA) to market the fesoterodine fumarate extended release capsules in strengths of 4 mg and 8 mg, it said in a BSE filing.
The approval late on Tuesday by the U.S. Food and Drug Administration came earlier than both companies had expected. It was issued a day after the health regulator said it would introduce measures to speed to market generic versions of complex drugs like Copaxone to help address the rising cost of pharmaceuticals.
Prime Minister Narendra Modi's government has in recent months slashed prices of medical devices such as knee implants and heart stents by up to 75 percent to make them more affordable.
The move comes almost a month after Abbott announced that it has halted sales of the next-generation dissolvable stents due to low commercial sales of the product.
The company has received EIR from the United States Food and Drug Administration (USFDA) based on the successful inspection of the active pharmaceutical ingredients (API) manufacturing facility at Alathur, Orchid Pharma said in a filing to BSE.
While acknowledging strict regulatory environment, he added that the company's pipeline of specialty products, to be rolled out over the next 3-4 years, is expected to act as a defence against generic price erosion and increase in competition, and boost profitable growth.
Sun Pharmaceuticals and Dr Reddy’s Laboratories gained around 2 percent intraday.
"Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (US FDA) for Propafenone Hydrochloride extended-release capsules USP, 225 mg, 325 mg, and 425 mg," Glenmark Pharmaceuticals said in a BSE filing.
The scope of the study by the regulator will only be limited to Delhi, Gurgaon, Faridabad and Noida for now
The pharma sector saw a sharp recovery towards the end of the week with gains of 3% as discussion on new pharma policy got postponed in India. There was some positive momentum in liquor stocks after the Supreme court clarified that the liquor ban near highways does not apply within city limits.
The drug is intended to be used for treatment of moderate to severe plaque psoriasis.
The new ministry could be named Ministry of Pharmaceuticals and Medical Devices, Minister of State for Chemicals and Fertilisers Mansukh L Mandaviya said in a written reply in the Lok Sabha.
Another tough past week for pharmaceutical stocks, many have sunk on weak Q1 results due to destocking of channel on account of GST rollout and US pricing pressures
While such rules are common elsewhere in the world and adhered to by large pharmaceutical companies, they are not set in stone in India, where campaigners have long demanded a crackdown on unethical selling practices. These have included gifts ranging from electrical appliances to foreign junkets to encourage doctors and pharmacists to prescribe and stock certain medications.
"The company has received approval from the United States Food and Drug Administration (USFDA) for its ANDA for Doxycycline capsules USP 75 mg and 100 mg," Alembic Pharmaceuticals said in a BSE filing today.
Natco Pharma announces successful EIR from the US Food and Drug Administration (USFDA) for the inspection conducted at its drug manufacturing facility in Kothur village in Mahabubnagar district during January 16–24, 2017, the company said in a BSE filing today.
"The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture Sevelamer Carbonate tablets 800 mg," Aurobindo Pharma said in a BSE filing today.
Vozet is indicated for the treatment of allergic Rhinitis and chronic Urticaria.
Government is looking at introducing a new National Pharmaceuticals Policy and is already in the process of working out details.
Drug firm Zydus Cadila today said it has received tentative nod from the US health regulator to market Fingolimod capsules used for treatment of multiple sclerosis
Drug firm Ajanta Pharma today said its promoters have sold 27 lakh shares in the company representing about 3.07 percent of its paid-up capital
Along with establishing a new plant, the company is assessing new products from its global respiratory and vaccines pipeline and reviewing these for a possible launch in India.
In case you missed it, here's a recap of all that happened in the pharma sector this week.