JB Chemicals & Pharmaceuticals Ltd on Thursday announced the filing of its first Abbreviated New Drug Application with the United States Food and Drug Administration.
'We are in close touch with Indian officials at all levels. We are also closely coordinating with our allies, friends, and Quad partners about how we can collectively support India in its hour of need,' a senior Biden administration official told reporters
The US Food and Drug Administration has tightened rules for selling dietary supplements in the US market, making compliance with current good manufacturing practices mandatory for manufacturers.
The central government is importing COVID-19 vaccines and is in talks with COVID-19 vaccine manufacturers Pfizer and Johnson & Johnson, Union Minister of State for Home Affairs G Kishan Reddy said.
Wockhardt Ltd said on Tuesday it has got US Food and Drug Administration's approval to market painkiller tablets containing a combination of Dextropropoxyphene napsylate and Acetaminophen in the US market.
'WHO issued an emergency use listing for Covovax, expanding the basket of WHO-validated vaccines against COVID-19. The vaccine is produced by the Serum Institute of India under licence from Novavax,' the world health body said in a tweet on Friday.
Various domestic companies such as Ranbaxy, Wockhardt and Agila Specialities recently came under the US FDA scanner for lapse in manufacturing practices.
Trump has been aggressively promoting the use of hydroxychloroquine in the treatment of COVID-19 patients.
Post Ranbaxy episode, domestic pharma companies may face frequent inspections and deeper scrutiny.
With the US education system operating independently from the government, universities are adopting varying strategies when it comes to Covid vaccination.
The weakness in the stock was because of inspections by the American drug regulator at its Halol plant in Gujarat which resulted in eight observations, as well as a downward revision of speciality drug payoffs.
The US Food and Drug Administration (USFDA) has issued a warning letter to RPG Life Sciences for violation of current good manufacturing practice (CGMP) norms at its two plants at Ankleshwar and Mumbai.
As part of the charm offensive, New Delhi has invited global regulators -- including the FDA -- to visit Indian production units to get first-hand evidence of measures taken to ensure the quality of locally manufactured generics.
The US drug regulator raised the issue of significant deviations from the current good manufacturing practice (cGMP) in three of DRRD's plants in a letter issued in November 2015
The recent recalls come amid increased FDA scrutiny of medicines produced in India.
The company has been held responsible for the violation of the Drugs and Cosmetic Act, 1940 and the rules framed in 1945.
The results reported from the observational studies, on average, show that vaccination had 95 per cent efficacy against severe disease both from the Delta variant and from the Alpha variant, and over 80 per cent efficacy at protecting against any infection from these variants.
Researchers at McGill University in Canada carried out a survey of 28 experts working in vaccinology in late June 2020. The majority of those surveyed were mostly Canadian or American academics with an average of 25 years of experience working in the field.
The Food and Drug Administration says all those areas are currently in compliance with blood screening, but that expanded testing is now needed.
Gland Pharma, promoted by China's Fosun, has extended its gains, is up 40 per cent since its listing.
Travel companies are expecting a heavy rush to the US following the withdrawal of curbs on fully vaccinated travellers from select countries, including India, on November 8. The move will benefit those holding long-term tourist, business, and work visas. Also, new and extra flights by Air India and American Airlines are expected to provide better travel options.
Whistle-blower Dinesh Thakur will speak on Made-in-India drugs at an event in Washington.
Nestl India is preparing a blueprint for a possible relaunch.
Margaret A Hamburg, the first commissioner of the US Food and Drug Administration (US FDA) to visit India officially, will meet heads of major domestic pharma companies such as Ranbaxy, Wockhardt, Cadila Healthcare and Lupin in New Delhi.
Adar Poonawalla said he was hopeful that Covovax, the Novavax vaccine made by SII, will be launched around October this year for adults and for children by the first quarter of next year, depending on DCGI approvals.
Both the units were under the scanner of FDA since 2011.
Indian drugmaker Dr Reddy's Laboratories said on Thursday it had filed an application with the US Food and Drug Administration to market a generic form of GlaxoSmithKline's anti-nausea drug Zofran.\n\n
A common antibacterial substance found in toothpaste may combat life-threatening diseases such as cystic fibrosis, or CF, when combined with an already FDA-approved drug.
The recalled drugs were manufactured and distributed in the US by Ohm Laboratories.
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
'Many of them are angry as we could not contest in some seats due to pact with the Sena and lost with a thin margin in some segments'
'Supplies should start moving to the Serum Institute without any impediments.'
Slapped with Rs 242-crore fine by US authorities for rule violations at Toansa unit, say sources; 2nd such hefty rap in the recent past from US regulators for bending rules.
Company is among the few companies in the sector getting pulled up by FDA for violations at its factories in India.
As the pandemic spreads and the urgency for effective treatment of COVID-19 mounts, several countries, including the US, have started relying heavily on HCQ, majorly used in the treatment of malaria and rheumatoid-arthritis.
The US laws authorise the drug and health watchdog to assess and collect user fees for certain applications and supplements for human generic drug products
India's drug regulator Drugs Controller General of India has granted permission to Mumbai-based pharmaceutical company Cipla to import Moderna's COVID-19 vaccine for restricted emergency use in the country, official sources said on Tuesday.
