In a filing to the BSE today, the company said it "has received the final approval from the USFDA to market oxybutynin chloride extended-release tablets in the strength of 5 mg, 10 mg, 15 mg".
The manufacturing plant had completed the US Food and Drug Administration (USFDA) audit from February 6-15, 2017 with zero Form 483 observations, Zydus Cadila said in a statement.
A spotlight on Dr. Reddy's Laboratories (DRL), a big relief comes in from the US drug regulator for its active pharmaceutical ingredients (API) plant Miryalaguda.
The company sought approval through postal ballot for raising additional capital by way of one or more public or private offerings including through a Qualified Institutional Placement (QIP) to investors through issuance of equity shares or other eligible securities for an amount not exceeding Rs 1,000 crore, Wockhardt said in a filing to BSE.
The USFDA has given its final approval to market mesalamine delayed-release tablets USP 1.2 g in the US market. Zydus Cadila was the first to file an Abbreviated New Drug Application (ANDA) for the generic version of Lialda (mesalamine), the company said in a BSE filing.
Official data on Bihar's narcotics seizure in 2016-17 shows an increase in volume of this illegal trade.
The bottomline growth was impacted by Rs 81 crore exceptional item, high expenses and decline in sales across Europe, Latin America, and other markets. The expenses shot up 13.6 percent to Rs 2,152 crore on sequential basis. Here are a few key highlights from Glenmark’s Q4 earnings call.
The US Court of Appeals for the Federal Circuit has affirmed judgement in favour of Zydus Pharmaceuticals (USA) Inc, holding that its proposed generic version of Lialda does not infringe a US Patent, the company said in a statement.
Prime Minister Narendra Modi last month hinted towards a legal framework to make doctors prescribe generic drugs and the subsequent notice by MCI enforcing the same has sent medical community in the throes of a debate.
In a BSE filing, the company said it has received abbreviated new drug application (ANDA) final approval for olmesartan medoxomil tablets - 5 mg, 20 mg, and 40 mg.
"Doctors write prescription in such a way that poor people do not understand the handwriting and he has to buy that medicine from private stores at high prices,’’ said Prime Minister Narendra Modi , while inaugurating a multi-specialty hospital in Surat on Monday.
The drug is being evaluated for the treatment of moderate-to-severe plaque psoriasis, the two companies said in a statement.
Drug firm Alkem Laboratories today said the US health regulator has inspected its Baddi plant and issued three observations on account of violation of good manufacturing norms.
Glenmark said it plans to initiate clinical development with a phase two study of GSP 304, a new orally administered formulation, in subjects with mild to moderate COPD, as determined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria.
The pharma major announced a dividend of Rs 3.25 a share; it even received a nod from US FDA for a drug that is used to treat spasticity in relaxing muscles
"I am working on a new system where there will be competition in the Drug Industry. Pricing for the American people will come way down!" Trump said in a Twitter post.
The company "announced today the launch of generic paxil CR extended release tablets, 12.5 mg, 25 mg and 37.5 mg, having received an approval from the United States Food and Drug Administration (FDA) earlier", Lupin said in a BSE filing.
The regulator has been fixing and revising the prices of drugs, and by January this year, when it had slashed the prices of 33 drugs, over 620 drugs had been placed under the price control sine April 2016.
Biocon Chief Kiran Mazumdar Shaw says India is not an outsourced services country anymore, it is an innovation and knowledge partner.
In a BSE filing, Lupin said "its Japanese subsidiary Kyowa Pharmaceutical Industry Co, Ltd and Astellas Pharma Inc have entered into an agreement providing Kyowa the exclusive right to distribute and promote extended-release tablets of quetiapine fumarate in Japan".
Pfizer Inc on Thursday said it received subpoenas from the U.S. Attorney's Office for the District of Massachusetts related to the drugmaker's support for organizations that provide financial help to Medicare patients.
Cipla is now concentrating on specific areas for growth. In emerging markets, Brazil and China are its priority markets, where measured approach will be taken, Umang Vohra, Managing Director of the company.
The government today made it mandatory for stent makers to maintain production and supply of coronary stents by invoking an emergency clause under drug price control law citing reports of shortage in market.
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."
According to average of estimates of analysts polled by CNBC-TV18, revenue during the quarter may increase 11.6 percent year-on-year to Rs 7,905.3 crore, driven by Sun's authorised generic (AG) launches of Daichi Sankyo drugs in US.