Searched for
FDA CERTIFICATION
Compliance squeeze, global scrutiny redefine India’s $30 billion pharma export playbookAs global markets prioritise quality and regulatory trust, India’s pharma sector is recalibrating beyond its traditional cost advantage.- Zepto’s Mumbai facility resumes operationsA fortnight ago, the FDA had revoked the facility’s food license following an investigation in which they found fungal growth on food artic...
- Maharashtra FDA suspends food licence of Blinkit dark store in PuneMaharashtra's FDA has suspended Blinkit's food license in Pune's Balewadi area due to regulatory non-compliance. An investigation revealed ...
- FDA issues show cause notice to pharma firm in Palghar for illegal export of opioidsPalghar's Food and Drug Administration took legal action against Aveo Pharmaceuticals for alleged illegal opioid export after a BBC report ...
- Australia's Mayne Pharma sues Indian drugmaker Sun Pharma over patent infringementMayne Pharma sued India's Sun Pharma for allegedly infringing patents on IMVEXXY, a drug for menopause-related vaginal pain. The lawsuit wa...
- After India, European Union to probe Wanbury Pharma for illegal exportEMA’s involvement in the case comes two weeks after the Drugs Controller General of India gave an export certificate to Wanbury to supply d...
- CDSCO plans surprise checks at drug manufacturing sitesThe move comes amid growing concern about the quality of medicines made in India and demands for a tighter inspection mechanism by regulato...
- Kamani Oil Industries first Indian edible oil firm to get FDA licenceKamani Oil Industries today said it has become the first Indian edible oil firm to get Food and Drug Administration (FDA) licence.
- Meda and Cipla sue Apotex to enforce Dymista patentsIn June 2013, Cipla granted the global commercialisation rights for 'Dymista' to Meda AB except for certain geographies.
- USFDA issues warning to Indian drug maker Marck BiosciencesMarck Biosciences, now known as Amanta Healthcare received warning letter by US drug authority. USFDA found flase data and dead & decaying ...
- Haryana FDA to launch online system for giving licensesHaryana FDA will soon launch an online system for giving licenses to chemist shops, medicine factories, renewal of license, and other certi...
- Wockhardt plunges 14% as USFDA issues import alert on Chikalthana PlantThe Chikalthana facility received ‘483’ observations after the USFDA raised several concerns. This is the second plant in India to get impo...
- Watson Laboratories send patent challenge notice to Ranbaxy for acne drugRanbaxy Laboratories' US arm has received a notice from Watson Laboratories, challenging the patent of acne treatment drug Absorica.
- Ranbaxy shares fall over 5% as trouble brews in US marketThe stock plunged over 5% on reports that the US-based Ohm Laboratories-the company's facility in US, is under the surveillance of FDA.
- Apollo Pharmacy reviewing quality of Ranbaxy drugs"We haven't suspended the drugs per se, but our medical oversight committee has asked for FDA and GMP certificate for medicines that we dis...
- Aurobindo gets USFDA's tentative nod for CrestorAurobindo Pharma said it has received tentative approval of the USFDA for the generic version of Crestor tablets used in the cardiovascular...
- Glenmark confirms patent challenge of fluticasone lotionGlenmark Generics Ltd's US subsidiary confirmed Nycomed US filed a patent infringement lawsuit on Dec 12, 2008, in the US District Court, E...
- DCGI may extend pharma export licence tenureHurdles faced by pharmaceutical companies while accessing global markets may ease now.
- Glenmark confirms Abbott suit against Tarka genericGlenmark Pharmaceuticals has confirmed that Abbott has filed a suit in the US District Court of New Jersey on December 7, seeking to preven...
- Enforce medical devices standards strictlyA year ago, the Drugs Controller General Of India’s office, the frontline regulatory outfit of the Central Drug Standard Control Organisati...
Load More
