American drug company Akorn Inc has signed a Letter of Intent with Indian pharmaceutical giant Cipla to develop and supply an oral anti-infective drug in the United States.
Dr Reddy's Laboratories Limited announced on Thursday that the United States Food and Drug Administration has issued final approval for the company's abbreviated New Drug Application for Ciprofloxacin tablets 100 mg, 250 mg, 500 mg and 750 mg.
Lupin Ltd received US Food & Drug Administration's approval for its abbreviated new drug application for Cefuroxime Axetil tablets.
Indian drugmaker Dr Reddy's Laboratories said on Thursday it had filed an application with the US Food and Drug Administration to market a generic form of GlaxoSmithKline's anti-nausea drug Zofran.\n\n
Indian drugmaker Dr Reddy's Laboratories Ltd said on Wednesday it has filed with the US Food and Drug Administration to market a generic version of Aventis Pharmaceuticals' anti-allergy drug Allegra.
Dr Reddy's Laboratories has filed an Abbreviated New Drug Application with the United States Food and Drug Administration for Levetiracetam tablets, 250, 500 and 750 mg.
JB Chemicals & Pharmaceuticals Ltd on Thursday announced the filing of its first Abbreviated New Drug Application with the United States Food and Drug Administration.
Ahmedabad-based Zydus Cadila group has filed 12 Abbreviated New Drug Applications in fiscal 2003-04 even as the company has set a target to file 16-18 ANDAs in the current financial year.
Drugmaker Dr Reddy's Laboratories has filed an application with the US Food and Drug Administration to market a generic form of Eli Lilly's schizophrenia drug Olanzapine in the US
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The company has launched the Decitabine for injection in the strength of 50 mg in the US market following approval by the United States Food & Drug Administration of Dr Reddy's abbreviated new drug applications, it said in a statement.
Gland Pharma, promoted by China's Fosun, has extended its gains, is up 40 per cent since its listing.
It is the generic version of Teva Women's Health's Seasonale tablets
Sun Pharma to retain these in most markets; US could be the exception, where the Ranbaxy name has taken a hit.
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The company's US subsidiary, Lupin Pharmaceuticals Inc has launched its Ciprofloxacin for oral suspension in the US market in the strengths of 5 g/100 mL (250mg/5 mL) and 10 g/100 mL (500 mg/5 mL), Lupin said in a statement.
The company has received the tentative approval from the US Food & Drug Administration to manufacture and market these combination tablets in strengths of 600mg/300mg/ 300mg, a statement by Aurobindo Pharma said.
Riluzole is indicated for the treatment of amyotrophic lateral sclerosis.
One of the subsidiaries of Sun Pharma has executed a settlement agreement with Novartis, stipulating a dismissal of the lawsuits filed in the United States against the company regarding submission of an Abbreviated New Drug Application for a generic version of Gleevec, the Indian drug major said in a statement.
The company has received final approval from the US Food and Drug Administration for its Abacavir Sulfate Lamivudine, and Zidovudine Tablets, Lupin Ltd said in a statement.
With all major US export-oriented drug manufacturing plants in the country up for inspection in 2022, some estimates peg that at least 20-30 per cent of the new product launches lined up for the US will be subject to on-site inspection by the US Food and Drug Administration (USFDA). The last two years saw limited physical inspections due to travel restrictions during the pandemic. "Pre-Covid, the frequency and number of inspections of manufacturing plants in India by USFDA had increased significantly," analysts from ICICI Securities Research noted. "With growing ANDA filings, especially for complex products. "We expect this trend to return with the environment normalising," analysts from ICICI Securities Research noted.
According to the petition copies, Hospira has alleged that Aurobindo's Abbreviated New Drug Application (ANDA) to make generic version of dexmedetomidine hydrochloride injection would infringe its patented drug Precedex.
The weakness in the stock was because of inspections by the American drug regulator at its Halol plant in Gujarat which resulted in eight observations, as well as a downward revision of speciality drug payoffs.
Even smaller companies like Torrent Pharma and Alembic file five to 10 ANDAs every year.
The company has launched only 3 new products during 2015 when compared to 14 launches in 2014
Currency played an important role in Q2, with US dollar, Japanese yen and euro appreciating vis-a-vis the Indian rupee, while the Brazilian real, South African rand and Russian ruble depreciating against rupee.
Takeda had filed a case of patent infringement in response to Zydus' abbreviated new drug application.
Sun Pharma profit down 30% over compliance costs, lower sales.
DRL launched four new products in North America during the previous quarter.
The US Drug maker requested the court to pass an order to restrain DRL from commercially manufacturing, using, offering for sale, selling, marketing, distributing, or importing DRL's generic paricalcitol injectable products prior to the expiration of said patents.
In a development that could hasten the entry of the generic version of Gleevec into the US market, Indian drug major Sun Pharma has sued Novartis Pharmaceuticals Corp in the District Court of New Jersey, demanding rights to launch a generic version of the cancer drug before the Novartis patent expires.
The fees for facility inspection of foreign companies have been reduced
'The focus for value creation will be on all business segments.'
Shares in Sun Pharmaceutical Industries fell by more than 5 per cent after the company settled a patent suit with Pfizer Inc related to its acid-reflux drug for $550 million.
Pharma shares were the top gainers led by Lupin after the company received EIR from USFDA for its Goa facility
Cipla, though late in changing its strategy for international markets, has in recent years taken an inorganic route for expansion.
US will remain a growth driver, with launches & existing portfolios set to result in 15% growth for FY15.
The US laws authorise the drug and health watchdog to assess and collect user fees for certain applications and supplements for human generic drug products
Companies asked to give data for three batches instead of one; move may lead to significant rise in development cost of generics
Check out some of the stocks that will react on the basis of their numbers in the near term.
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