Ranbaxy Laboratories on Monday said it has received tentative approval from the United States Food and Drug Administration to manufacture and market anti-hypertension drug Quinapril Hydrochloride in the US.
The United States Food and Drug Administration on Tuesday banned the import of more than 30 generic drugs manufactured by Ranbaxy Laboratories Limited alleging that poor quality control at the firm's factories could be harmful to users of these medications used to treat everything from high cholesterol to Type 2 diabetes to everyday allergies.
Indian drug maker Alembic Ltd plans to expand its bulk drugs business in the United States by joining hands with US formulations makers, the Bombay Stock Exchange said on Thursday.
The anti-depressant drug market in the US is primarily ruled by Effexor XR (Venlafaxine) of Wyeth (now owned by Pfizer).
In comparison, Indian companies received only 23 out of 139 final approvals (16.54 per cent) in the corresponding period in 2006.
Sun Pharma Ltd has received tentative approval for cancer drug Ondansetron from US Food and Drug Administration.
Orchid Chemicals & Pharmaceuticals on Monday said it has received US health regulator's approval to sell anti-epileptic levetiracetam tablets in the American market.
Due to the massive short supply of Paxlovid, demand for Indian generic versions has gone up through Chinese e-commerce platforms.
Ranbaxy Laboratories Ltd has received the US Food and Drug Administration approval to market Fosinopril sodium tablets in the United States.
Scientists have developed a new and more effective drug to help smokers quit the habit, which is known to reduce the life span of those addicted by about 10 years and is the single most important factor for heart attacks the world over.
FDA said as of now it has issued an emergency use authorisation to allow hydroxychloroquine and chloroquine products donated to the Strategic National Stockpile to be distributed.
Glenmark said it along with its US-based partner has got the US health regulator's nod to manufacture and market two oxycodone products, used for treating moderate to severe pain, in the American market. The company's US arm, Glenmark Generics Inc and Lehigh Valley Technologies (LVT) have received US Food and Drug Administration nod for Oxycodone immediate release capsules, the company said in a filing to the Bombay Stock Exchange.
Ranbaxy Laboratories, Dr Reddy's Laboratories and Sun Pharma's US subsidiary Caraco Pharmaceuticals are among the 13 generic manufacturers to get first generic approvals from the US Food and Drug Administration to manufacture and market generic versi
Traction for its specialty portfolio, a strong showing in the domestic market, and better regulatory compliance are positives for the country's largest pharmaceutical (pharma) company, Sun Pharmaceutical Industries. Given the triggers, some brokerages have increased their earnings per share estimates and target price for 2024-25 (FY25). This should sustain the momentum for the stock, which has been one of the major pharma gainers in 2023-24 (FY24), rising 57 per cent. It is currently trading at Rs 1,547 per share.
China has started producing five drugs that can be used in four different cocktails to treat AIDS patients, whose numbers are rising alarmingly.
Earlier, Jaslok Hospital had issued an advisory to its doctors to avoid prescribing drugs manufactured by Ranbaxy.
Lupin Ltd received US Food & Drug Administration's approval for its abbreviated new drug application for Cefuroxime Axetil tablets.
Riluzole is indicated for the treatment of amyotrophic lateral sclerosis.
The FDA Maharashtra on Friday lodged an FIR against Snapdeal.
Ranbaxy Laboratories has received tentative approval from the US Food and Drug Administration to manufacture and market Fosinopril Sodium and Hydrochlorothiazide tablets in 10 mg/12.5 mg and 20 mg/12.5 mg strengths
Sun Pharmaceutical Industries on Friday said that it has received the US Food and Drug Administration's nod to market a generic version of alprazolam, an anti-anxiety drug, in the US market.
The US president said the drug has gotten a bad reputation only because 'he was promoting it'.
A vacation bench of Justices NJ Jamadar and Sharmila Deshmukh passed the decision on Wednesday while hearing a petition filed by the company challenging two orders of the state government.
Whistle-blower Dinesh Thakur tells briefing on US Capitol Hill: 'One in five medicines manufactured and distributed in India are spurious.' Aziz Haniffa reports from Washington, DC.
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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.
Samples of the powder for babies did not conform to standard pH value during a laboratory test, the regulator said.
The drug controlling authority in Chhattisgarh on Thursday raided and sealed a unit of an antibiotic manufacturing company, whose product was used in sterilisation camps in Bilaspur district where 13 women died and several others fell ill.
Ranbaxy Laboratories has received tentative approval from the US Food and Drug Administration to manufacture and market Lamivudine Tablets in 150 mg strength, the company announced on Saturday.
Ranbaxy on Tuesday announced it had got final approval from the US Food and Drug Administration to market its Metformin HC1 tablets for diabetes.
Ranbaxy Laboratories Ltd today said it has received tentative approval from the US Food and Drug Administration to manufacture and market Glimepiride tablets of 1 mg, 2 mg, 4 mg and 8 mg.
The Food Safety and Standards Authority of India (FSSAI) has commissioned a quality check on MDH and Everest products. This follows complaints that several popular spice mixes of the two leading brands contained traces of ethylene oxide more than the permissible levels, official sources said. This move by FSSAI comes after Hong Kong and Singapore recalled variants of the two masala majors' products in their countries.
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