Riluzole is indicated for the treatment of amyotrophic lateral sclerosis.
The trouble-stricken company has sought appointment with at least two major hospitals -- Mumbai-based Jaslok and Gurgaon-based Medanta Medicity.
The company has received a Civil Investigative Demand from the US Department of Justice, Ranbaxy Laboratories said in a filing to the BSE.
Justice Rajiv Sahai Endlaw allowed 454 petitions moved by various pharma and healthcare majors, like Pfizer, Glenmark, Procter and Gamble and Cipla, challenging the government's March 10 notification banning the FDCs, saying the decision was taken by the Centre without following procedure prescribed in the Drugs and Cosmetics Act.
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.
DCGI, health ministry initiate dialogues with foreign regulators, try to understand global best practices
The contract research and manufacturing services may soon replace generic drugs manufacturing as the preferred business option for Indian pharmaceutical industry, if growing revenues from CRAMS business is any indication.
Import alert on unit-6 facility might be lifted by FDA by Sept.
The BCG analysis shows Lupin gave an annualised average TSR of 29.9 per cent, ahead of the 18.4 per cent of Israel-based Teva Pharmaceutical, the world's largest generics maker. Teva is next on the list. Another Indian generic maker, Glenmark, occupies third position, with an 18 per cent TSR to its investors.
Several firms are stepping up to help their workforce cope with soaring temperatures
The company has entered into an 'in-licencing agreement' with Gilead Sciences Inc to produce and sell, under licence, three new HIV/AIDS drugs which are currently in late stages of clinical development, Ranbaxy Laboratories said.
The pharmaceutical and the consumer durables sectors, which depend on China for imports, have not been impacted yet due to unrest in China with people protesting against lockdowns. But the lockdown could have an impact on the supply of components used in consumer durables if it continues for the next fortnight. In the pharmaceutical industry, Indian players import 66-70 per cent of their bulk drug requirements from China.
As uncertainty looms large in Afghanistan, Indian pharma exporters are apprehensive to send goods to the war-torn country and the target of exporting $126 million worth of pharmaceutical goods to the Taliban-ruling nation now depends on the future outcome. Udaya Bhaskar, director general of Pharmaceuticals Export Promotion Council of India (Pharmexcil) body under the Department of Commerce on Tuesday said as the situation is grim over there and India pharma exporters have cordial relations with Afghanistan. "The projected target for 2021-22 is $126.22 million.
Apart from favipiravir and remdesivir, its key Covid-19 products, DRL has already launched nutraceutical products and hand sanitisers during the pandemic.
National security advisor Ajit Doval on Friday suggested that various central armed police forces of the country should have "jointness" and interoperability among themselves like the ongoing plan for the defence forces.
Less than three months after roaring into us market with generic for cholesterol-reducing Lipitor, Dept of Justice files for permanent injunction against Ranbaxy.
Companies run till now by mostly their promoters are increasingly inducting professionals to head their teams.
Generic drugmakers cannot be sued under state law for adverse reactions to their products.
The notice says the company can restart manufacturing these products only after the authority approves their revised formulation sheets.
The Supreme Court on Tuesday tore into Patanjali Ayurved's defence for putting out misleading advertisements, rejecting the apology from yoga guru Ramdev and the firm's managing director Acharya Balkrishna as 'lip service' and warned them against perjury.
Ranbaxy Laboratories has received approval from the U.S. Food and Drug Administration to manufacture and market Clarithromycin XL 1,000 mg tablets.
Australian dual Olympic silver medal-winning kayaker Nathan Baggaley has been arrested following a drug bust, local media reported on Sunday.
Cheap bulk drug imports from China may soon post a threat to the Rs 20,000 crore (Rs 200 billion) domestic bulk drug industry.
The PIL , filed by advocate M L Sharma, sought action against Ranbaxy for allegedly supplying substandard and adulterated drugs
India's biggest drug maker Ranbaxy Laboratories Ltd has put in its bid to acquire generic business of German pharmaceutical firm Merck.
PharmaSecure, a US based company, is in talks with Indian drug majors to implement a new, cost-effective, SMS-based technology that would allow consumers to check the authenticity of the drug - in a strip, tablet or a bottle - by directly getting in touch with the manufacturer.
The non-branded generic drugs (sold under chemical names such as cetrizene, omeprazole and nimusulide), which constitute about 8 per cent of the Rs 30,000 crore (Rs 300 billion) Indian pharmaceutical market, is currently not subjected to any such margin cap and according to a study done by the department some of them such are even sold at a margin as high as 1,000 per cent in the market.
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.
While the opposition party asked the government to stop boasting about India being a pharmacy to the world and take strictest action, the ruling party accused it of deriding India in its "hate" for Prime Minister Narendra Modi.
It has approved an amendment to the Drugs and Cosmetics Act.
Since 2013, the FDA has banned around 30 Indian drug manufacturing units for various violations
They said 37.5 crore of Covishield doses from the Serum Institute of India and 28.5 crore Covaxin doses from Bharat Biotech will be procured by December.
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
