The FDA issued the letter on October 15, and has given the company 15 days to respond.
Cadila Pharmaceuticals Ltd on Monday said it would market anti-cancer drugs GCS
Cadila Pharmaceuticals has chalked out ambitious plans to set up close to eight units in its upcoming PhaEZ Park near Ahmedabad, which is touted to be the largest in India. The eight units will come up in a phased manner in a span of six to seven years.
If India caves in to US pressure as Trump hopes it will, he will further try to blackmail it into submission, points out Ramesh Menon.
Pharma major Zydus Cadila on Thursday entered into an agreement with Mayne Pharma of Australia to set up a 50:50 joint venture company
The company said the drug will be made available across India through the group's strong distribution chain reaching out to government and private hospitals treating COVID-19 patients.
A Union environment ministry's expert appraisal panel felt that the project proponent, CPL Infrastructure Pvt Ltd, a subsidiary of Cadila Pharmaceuticals Ltd, had failed to give requisite details for the proposed park in Dhandhuka Taluka in Ahmedabad.
Cadila Healthcare Ltd has received approval from USFDA for marketing anti-coagulant, Warfarin tablets.
Ahmedabad-based Zydus Cadila has made a foray into the US generic formulation segment by setting up a subsidiary Zydus Pharmaceuticals USA, Inc.
The regulator has given the company 15 days to take corrective measures and report back to it.
Cadila Healthcare Ltd has received tentative approval from US FDA to market its antibiotic, Gatifloxacin tablets, 200 mg and 400 mg, in the US market.
Cadila Healthcare Ltd has announced that Zydus Cadila has received its very first approval from USFDA to market Atenolol, an anti-hypertensive drug, in the US market.
The voluntary move comes a little more than a year after the Central Drugs Standard Control Organisation, the central authority that approves new drugs for marketing, had asked the drug makers to withdraw the 'combination drugs' as they are 'unnecessary' and may pose health hazards. The Drugs Controller General of India had banned 294 combination drugs sold under nearly 1,053 brand names from the market in June 2007.
Cadila Healthcare Ltd has received tentative approval from the USFDA to market Pravastatin Sodium Tablets in the US market.
Can Interferon alfa-2b treat COVID-19 effectively?
Cadila Healthcare Ltd on Monday said it has received tentative approval from the US FDA to market Levofloxacin tablets of 250 mg, 500 mg and 750 mg in the US market.
Since 2013, the FDA has banned around 30 Indian drug manufacturing units for various violations
With the government asking the companies to operate with only 50 per cent staff strength, and exports dipping to almost zero, the truck and bus drivers idling at the petrol pump say they hardly have any work now. At a petrol pump on the deserted Bavla-Changodar highway near Ahmedabad in Gujarat, several trucks and buses are neatly parked in a row.
Ahmedabad-based Zydus Cadila, Bharat Biotech's intra-nasal candidate are among the candidates who got approval from the expert panel to conduct clinical trials, Sohini Das reports.
The trial is being conducted in three phases by segregating children into categories according to their age. The first trial was started in the age group of 12 to 18 years followed by the age group of 6 to 12. Trials for children between the ages of and 2-6 years are currently undergoing trials.
The government has also given permission to 20 plants to produce the antiviral drug.
Zydus Pharmaceuticals Inc, the US arm of Zydus Cadila has entered into a strategic alliance with Mallinckrodt Pharmaceuticals Generics, a business unit of Tyco Healthcare to market generic products in the US.
This import duty exemption would remain in force till October 31 this year.
When compared to the domestic sales of April 2019, the growth is around 37 per cent. However, compared to the previous month (March), the growth is 18.4 per cent.
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.
The teams were from Gennova Biopharmaceuticals Ltd Pune, Biological E Ltd Hyderabad and Dr Reddys Laboratories Ltd Hyderabad.
Indian Council of Medical Research had also recommended the use of hydroxychloroquine for treating healthcare workers handling suspected or confirmed coronavirus cases and also the asymptomatic household contacts of the lab-confirmed cases.
Cadila, Biocon developing rapid antibody testing kits; Eris, Mylan, Gland importing. There are two kinds of testing for the novel coronavirus - the real-time polymerase chain reaction test kit that uses throat or nasal swabs and provides results in a few hours, and the other is antibody-based rapid testing kit that use blood samples and provides results in a few minutes.
This is because while the emergency authorisation for treating Covid was a recent move, the drug has been used since years for rheumatoid arthritis and autoimmune lupus.
Government institutions and pharma industry are examining if a 'cocktail' approach to making a multi-variant Covid-19 vaccine works against multiple strains of the ever-mutating virus, reports Sohini Das.
The new drugs to come under price control include commonly-used antibiotics and painkillers
Currency played an important role in Q2, with US dollar, Japanese yen and euro appreciating vis-a-vis the Indian rupee, while the Brazilian real, South African rand and Russian ruble depreciating against rupee.
The Central Drugs Standard Control Organisation said while the rights, safety, and well-being of trial subjects were of paramount importance, protocol amendment, deviation or modification might be necessary in some cases owing to unavoidable circumstances.
© 2026 Rediff.com - Investor Information - Advertise with us - Disclaimer - Privacy Policy - Sitemap - Feedback - About us - Terms of use - Grievances