Cipla has got tentative approval from the USFDA for its abbreviated new drug application for anti-HIV/AIDS drug Slamivudine.
The company said it is launching the product immediately
Riluzole is indicated for the treatment of amyotrophic lateral sclerosis.
The tailwind of low price erosion in the US generics market, seen by domestic pharmaceutical companies in calendar year 2023 (CY23), may be reversing slowly, caution analysts. According to the latest data from US-based Centers for Medicare and Medicaid Services (CMMS), price erosion in calendar year 2024 (CY24) on a year-to-date (YTD) basis stood at a high of 15 per cent in the oral solid dosage (OSD) segment compared to a low of 1 per cent in CY23. This erosion, according to a report by Antique Stock Broking, was the highest in the last three years.
This generic Doxorubicin HCl Liposome injection USP, 2 mg/ml is therapeutically equivalent to Doxil Liposome Injection, 2 mg/ml of Janssen Research and Development, LLC.
'That is a significant milestone for us and something we aspired for.'
Sun Pharmaceutical Industries reported a 34 per cent year-on-year (Y-o-Y) jump in net profit to Rs 2,654.6 crore in Q4FY24.
Ranbaxy Laboratories has received US Food and Drug Authority approval for Benazepril Hydrochloride, a high blood pressure drug.
Aurobindo Pharma on Monday said it has received a tentative new drug approval from USFDA for its fixed dose combination product used for treating HIV-1 infection.
Ranbaxy Laboratories on Friday said it had received approval from US Food and Drug Administration to manufacture and market nitrofurantoin monohydrate macrocrystals capsules (100 mg) and planned to bring the new drug to the market in April.
It is the generic version of Teva Women's Health's Seasonale tablets
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.
Drug-maker Ranbaxy Laboratories on Wednesday said it has signed an agreement with the US health regulator to lift a ban on the import of drugs from certain manufacturing plants in India and will pay up to $500 million to settle a case lodged by the Department of Justice.
The reasons given for the refusal include misbranding, adulteration, packaging, labelling, pesticides, unapproved products.
'There is no reason why we should break this business up.'
FDA inspectors visited the Mohali plant in the process of giving approval to Ranbaxy's application for Valsartan.
Domestic firms Aurobindo Pharma, Glenmark Pharmaceuticals and Natco Pharma have received US health regulator's approval to market their generic Rizatriptan Benzoate orally disintegrating tablets used for treating migraine in the American market.
Glenmark Generics Inc USA, the subsidiary of Glenmark Generics Ltd has received nod for it's Hydrocortisone Butyrate Cream USP (0.1 per cent), abbreviated new drug approval from the United States Food and Drug Administration, Glenmark Pharmaceuticals said in a statement.
Leading drug firms Aurobindo Pharma, Sun Pharma and Jubilant are recalling different products in the US market for various reasons, as per the latest enforcement report by the US Food and Drug Administration (USFDA). While Aurobindo Pharma is recalling Cyanocobalamin Injection, which is used to treat and prevent lack of vitamin B12, Mumbai-based Sun Pharma is recalling a drug used to increase the production of natural tears in eyes. Similarly, Jubilant Cadista is recalling a drug which is used to treat different inflammatory conditions.
Global Pharma Healthcare is recalling entire lots of eye drop linked to vision loss in the US, according to the US Food and Drug Administration. The Chennai-based company is recalling all lots of artificial tears lubricant eye drops distributed by EzriCare, LLC and Delsam Pharma to the consumer level due to possible contamination, the US health regulator said in a statement. "The Centres for Disease Control and Prevention (CDC) alerted FDA to an investigation of a multi-state cluster of Verona Integron-mediated Metallo--lactamase (VIM)- and Guiana-Extended Spectrum--Lactamase (GES)- producing carbapenem-resistant Pseudomonas aeruginosa (VIM-GES-CRPA) infections possibly associated with the use of the artificial tears manufactured by Global Pharma Healthcare," USFDA said.
Drug shortages in the US are at an all-time high, and price erosion has stabilised, which could benefit Indian pharmaceutical (pharma) companies with a US focus, according to analysts. Nuvama Research analysts said that US price erosion seems to have normalised to its old levels of 6-8 per cent and volumes are picking up with easing of inventory. Similarly, an ICICIdirect analyst noted: "Price erosion intensity has now moderated to a single digit and is expected to tone down a
Drug major Sun Pharma is recalling over 34,000 bottles of a generic medication, used to treat high blood pressure, in the US market due to failed dissolution testing. As per the US Food and Drug Administration's Enforcement Report, the US-based arm of Sun Pharmaceutical Industries is recalling lots of Diltiazem Hydrochloride extended-release capsules which are used to treat angina, high blood pressure and some types of irregular heartbeats.
The company has received final approval for its supplemental New Drug Application (sNDA) for Antara (Fenofibrate) capsules in 30 mg and 90 mg strengths from the United States Food and Drug Administration (USFDA), Lupin Ltd said in a statement.
'However, we have seen weakness in our active pharmaceutical ingredients business.'
Pfizer can show the FDA approval to the Indian regulator and present a case that based on whatever data submitted, the US regulator has granted a full marketing nod, says Sohini Das.
Indian drug firms like Marksans Pharma, Aurobindo Pharma, Zydus and Jubilant are recalling products in the US market, as per the latest enforcement report by the US Food and Drug Administration (USFDA). While Marksans Pharma is recalling diabetes drug, Zydus Pharmaceuticals (USA) is recalling drug which is used to reduce stomach acid. Similarly, Aurobindo Pharma (USA) is recalling pain relieving drug, while Jubilant Cadista is recalling a medication used to treat schizophrenia.
In May this year, Ranbaxy had pleaded guilty to 'felony charges' for violating manufacturing norms and agreed to pay $500 million penalty to US authorities.
Covovax is likely to be available on the portal in a few days at a price of Rs 225 per dose plus applicable GST.
Baltimore-based Lupin Pharmaceuticals Inc is recalling 5,60,922 pouches of Mibelas 24 Fe (norethindrone acetate and Ethinyl estradiol tablets and ferrous fumarate tablets) in the US, as per the latest enforcement report by the USFDA.
The BSE Healthcare Index is up 19 per cent as compared to BSE Sensex returns of 11 per cent during this period. Nitin Agarwal of DAM Capital highlighted this trend in a report last month. "After a sustained period of underperformance over FY21-23, the BSE Healthcare Index has once again captured the spotlight. "The recent uptick in performance has been driven by hospitals and emerging green shoots in pharmaceutical exports, particularly to the US, along with sustaining momentum in domestic branded formulations," he said.
Glenmark Pharmaceuticals Ltd on Tuesday said it has acquired the approved generic versions of certain over-the-counter drugs from Wockhardt Ltd in the US. The acquisition by the company's fully-owned subsidiary Glenmark Pharmaceuticals Inc, USA includes the approved abbreviated new drug applications (ANDAs) for famotidine tablets, 10 mg and 20 mg used to treat and prevent ulcers in the stomach and intestine, the company said in a statement. The company, however, did not disclose the financial details.
Benchmark BSE Sensex rose by 160 points on Thursday in choppy trade following gains in select banking and auto counters amid mixed global cues. The 30-share index gained 160 points to settle at 62,570.68 as 13 of its components advanced while 17 declined. The barometer opened lower but later gained momentum to touch a high of 62,633.56 in the day's trade.
Company had earlier received an import alert in February this year from the US Food and Drug Administration.
A three-member team each from the Central Drugs Standard Control Organisation (CDSCO) and the State Drug Controller visited the plant in Tamil Nadu's Kancheepuram, 40 km from Chennai, on Friday after the company recalled the eye drop.
Trump had said that he worked on removing a large number of bureaucratic obstacles to fast-track development and approval of a vaccine.
The move follows an FDA inspection of a Ranbaxy facility which identified significant violations of sound manufacturing practices.
Ranbaxy Laboratories Ltd said on Thursday that it has bagged the US Food and Drug Administration's approval for manufacturing and marketing Loratadine and Pseudoephedrine Sulfate Extended-release tablets.
GSK is continuing with investigations into the potential source of the NDMA, which is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.
Indian drug firms get a shot in the arm in the $12 bn Australian drug market as the Therapeutic Goods Administration (TGA), Australia agrees to accelerate the drug approval process in that country for Indian players who already have an approved plant and product from one of the stringent regulatory authorities like US, EU or Canada. From current sales of $340 mn, the Indian firms can see a significant upside in sales; felt Dinesh Dua, former chairman of the Pharmaceutical Exports Promotion Council of India (Pharmexcil), and the MD of Nectar Lifesciences. He highlighted that only 12 percent of the Australian drug market is generic, as against 80-90 per cent in the US or EU. Of this $1.5 bn generic drug market in India, Indian companies have a small share.
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