India, the largest maker of generic drugs, has also the poorest quality control
The partnership with Cuban-backed Cost Plus Drugs is expected to bolster Lupin's U.S. business, which already accounts for nearly 33% of its 2023 revenue.
The approval granted by the US Food and Drug Administration (USFDA) is for Minocycline Hydrochloride extended-release tablets of strengths 55 mg, 65 mg, and 115 mg, Zydus Lifesciences said in a regulatory filing.
The approval by the US Food and Drug Administration (USFDA) is for Varenicline tablets of strengths 0.5 mg and 1 mg.
The company has received approval from the US Food and Drug Administration (USFDA) for Obeticholic Acid tablets (5 mg and 10 mg), the Mumbai-based drug maker said in a statement.
The company has received the final approval for Levothyroxine Sodium for Injection in strength of 100 mcg/vial, 200 mcg/vial, and 500 mcg/vial from the US Food and Drug Administration (USFDA), the drug firm said in a statement.
The affected lot is manufactured by Ahmedabad-based Zydus Lifesciences and marketed in the US by New Jersey-based Zydus Pharmaceuticals (USA) Inc.
The company has received final approval from the US Food & Drug Administration (USFDA) for Calcipotriene and Betamethasone Dipropionate Foam, the generic version of Leo Pharma's Enstilar, Glenmark Pharma said in a statement.
The Hyderabad-based drug major is recalling 4,320 bottles of Tacrolimus Capsules which are used to prevent the body from rejecting a transplanted organ.
The company has received final approval from the US Food and Drug Administration to market Pitavastatin tablets in strengths of 1 mg, 2 mg, and 4 mg, the drug maker said in a statement
The approval granted by the US Food & Drug Administration (USFDA) is for bicardipine hydrochloride capsules of strengths 20 mg and 30 mg, Glenmark said in a statement.
The approval by the US Food & Drug Administration (USFDA) for the abbreviated new drug application (ANDA) of diclofenac sodium topical solution is for strength of 2 per cent, the company said in a statement.
Dr Reddy's says the allegations lack merit and it will defend against the charges
The final approval granted by the US Food and Drug Administration (USFDA) to the company's US arm Zydus Pharmaceuticals Inc is for the tablets of strengths 25 mg and 50 mg, it said in a regulatory filing.
Lupin Healthcare (UK) has received approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) to market a generic version of Spiriva, the Mumbai-based drug firm said in a statement.
The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of meclizine hydrochloride tablets of strengths 12.5 mg, 25 mg, and 50 mg, the pharmaceuticals company said in a regulatory filing.
The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Doxycycline Hyclate delayed-release tablets, the drug firm said in regulatory filing.
Pharma stocks are in focus as the health ministry has asked doctors to prescribe generic names of drugs versus branded names.
The buy back announced by Tata Consultancy Services is a very good start for the IT sector to return surplus cash to the investors, while also improving the return on earnings (RoE), says Nilesh Shah of Envision Capital.
Generic drug-maker Laurus Labs is considering going public through an initial offer of Rs 1,000 crore, reports an article in the Mint today.
The overall domestic pharma market was valued at USD 15.4 billion in 2014 and is expected to expand at a CAGR of 13.3 percent to USD 32.7 billion by 2020, the study noted.
Speaking to CNBC-TV18, S Ramesh, chief financial officer, Lupin says the company is expecting to launch about 100 new drugs in the next three years.
India is much tough market than US due to bureaucratic and regulatory uncertainties, says Vinita Gupta, Group President and CEO Lupin. But, the company aims to be a USD 5 billion company by 2017-18.
Indian pharmaceutical firms will have to shell out Rs 30 lakh for registration to seek approval for selling a generic drug in the US market following the fee hike by the American health regulator, Parliament was informed today.
Drug maker Aurobindo Pharma has got final approval from US Food and Drugs Administration (FDA) to manufacture and market Pioglitazone tablets in 15mg, 30mg and 45mg strength, and its earlier tentatively approved Pioglitazone Hydrochloride + Metformin Hydrochloride tablets in 15mg (base)/500mg and 15mg (base)/850mg strengths.