The move is in line with the NPPA's recent policy of putting a cap on prices.
A team of central agencies and the Uttar Pradesh drug department had carried out an inspection at the firm's office in Noida on December 29 and taken six more samples for testing.
Lupin Ltd received US Food & Drug Administration's approval for its abbreviated new drug application for Cefuroxime Axetil tablets.
Ranbaxy Laboratories Ltd said on Monday it has entered into a licensing agreement with US-based Gilead Sciences Inc for manufacturing and marketing of Active Pharmaceutical Ingredient and formulations containing anti-HIV drug Tenofovir.
Ranbaxy Laboratories on Thursday said that it had received final approval from US Food and Drug Administration to manufacture and market Ciprofloxacin.
Part research being farmed out to medical colleges, universities to cut cost and time.
Over 50 pharmaceutical companies have scaled down operations in Maharashtra and Gujarat and are moving out to states like Uttaranchal and Himachal Pradesh following steep hike in excise duty in the Union Budget.
For the poorest 20 per cent of Indians, the expenditure on medicines alone is 85 per cent of what they spend on their health, according to the National Sample Survey.
A notice issued by the Indian Health Ministry at the weekend said that a government-appointed committee of experts had found that the banned combinations were "likely to involve risk to human beings, whereas safer alternatives to the said drug are available."
In a landmark judgment likely to benefit Indian generic drug manufacturers in a big way, the US Supreme Court has ruled against patenting of products with slight modifications.
Drug maker Cipla always fought a lone battle to make drugs affordable in India.
Nicholas Piramal has signed an MoU with a French pharma company to manufacture an anti-chikungunya drug.
Dilip Shanghvi founded Sun Pharma in 1983.
Data also show that several other leading domestic pharma companies have recalled their products from the US
Pharmaceutical companies, which are sending across medical aid for flood affected people in Jammu and Kashmir, claim to be facing difficulties in distribution of drugs.
Maria Sharapova will attend an International Tennis Federation anti-doping hearing in London on Wednesday, British media reported, with the Russian facing a possible ban of up to four years for failing a drugs test at the Australian Open.
Covovax is likely to be available on the portal in a few days at a price of Rs 225 per dose plus applicable GST.
In two separate affidavits filed in the apex court, Ramdev and Balkrishna tendered unqualified apology for the 'breach of the statement' recorded in the November 21 last year order of the apex court.
The company did not comply to the 'good manufacturing practice' norms.
FDA had cancelled Ranbaxy's approvals to launch generic Nexium, Valcyte
According to respective company sources, Biological E is holding 200 million doses of its COVID-19 vaccine Corbevax while Bharat Biotech is sitting on a stockpile of 50 million doses of Covaxin.
Sun Pharmaceutical Industries Ltd on Thursday said its Halol facility in Gujarat has been listed under import alert by the USFDA with products manufactured at the unit now are subject to refusal of admission in the US market. The development follows an inspection of the facility by the US Food and Drug Administration (USFDA) from April 26 to May 9, 2022. "We now wish to inform you that the company has received a communication from the USFDA stating that the facility has been listed under Import Alert," Sun Pharma said in a regulatory filing.
The drastic measure will help the company to counter its failure to meet the pricing by generic drug manufacturers.
The government is likely to extend fiscal incentives for production of toys, bicycles and leather and footwear in the forthcoming budget as it looks to expand production linked incentive (PLI) scheme to cover more high-employment potential sectors, sources said. The government has already rolled out the scheme with an outlay of about Rs 2 lakh crore for as many as 14 sectors, including automobiles and auto components, white goods, pharma, textiles, food products, high efficiency solar PV modules, advance chemistry cell and speciality steel. The scheme aims to make domestic manufacturing globally competitive and create global champions in manufacturing, and it is yielding solid results, sources said.
Amending the earlier order, the authority on Saturday issued a fresh one allowing the firm to continue the production of these medicines.
The Central Drugs Standard Control Organisation (CDSCO) has initiated a probe in connection with the death of 18 children in Uzbekistan allegedly linked to Marion Biotech.
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
India's generic drug manufacturer, Dr Reddy's Laboratories, suffered a setback when a US' Court of Appeals ruled that it infringed on Pfizer Pharmaceutical company's patent for the blood pressure medicine Norvasc.
Reliance Retail Ventures Ltd has acquired a majority equity stake in digital pharma market place Netmeds for a cash consideration of around Rs 620 crore, Reliance Industries said in a late night statement on Tuesday.