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About 1207 results for "usfda"

Dr Reddy's Lab gets USFDA nod for Avandia Generic Tablets
India Infoline

FDA approves Aurobindo's epilepsy drug

Singapore: The US Food & Drug Administration (USFDA) has granted approval for Aurobindo Pharma's epilepsy prevention drug Lacosamide. Aurobindo Pharma is India's leading drugmaker. Epilepsy is the fourth common neurological disorder that affects ... Bio Spectrum Asia, 9 hours ago
Money Control

USFDA no 12,012 products since Jan '11: Sitharaman

New Delhi, May 2 (PTI) The US health regulator has refused entry of 12,012 Indian products, including drugs, into the American market between January 2011 and March 2016 for various reasons, including adulteration and misbranding, Parliament was ...
 Press Trust of India1 day ago USFDA rejected 12,012 products since January 2011: Nirmala Sitharaman  Economic Times1 day ago

USFDA rejected 12,012 Indian products since January 2011

The reasons given for the refusal include misbranding, adulteration, packaging, labelling, pesticides, unapproved products. The US health regulator has refused entry of 12,012 Indian products, including drugs, into the American market between January 2011 and March 2016 for various reasons, including adulteration and misbranding, Parliament was informed on Monday. "According to import refusal report data available on the US Food and Drug Administration (USFDA) website, 12,012 refusals of Indian ...
 Rediff.com1 day ago US drug regulator rejected nearly 12,000 Indian products in five years: Nirmala Sitharaman  DNA India13 hours ago

Biocon, Piramal & GSK buck the pharma trend, outperform amid absence of FDA issues

By Kiran Somvanshi ET INTELLIGENCE GROUP: Investors are essentially opportunists. At a time when USFDA has become a dreaded word for pharma stocks and most have lost fancy of the Street, few stocks have found favour with the investors. Biocon, ...
 Economic Times4 days ago
India Infoline

Semler Research now reviewing concerns of USFDA data integrity notice on serious violations of regulations

Semler Research Centre which has been issued a data integrity notice from the USFDA has said that it is in the process of reviewing the concerns raised by the agency. The global regulatory major has indicted the Bengaluru-based clinical research ...
 PharmaBiz1 week ago USFDA issues data integrity notice to Semler and other top pharma news  India Infoline1 week ago Drug applications based on Semler's data unacceptable: USFDA  Times of India1 week ago Semler appoints US consultant to make detailed response to US FDA's charges of data integrity  PharmaBiz4 days ago
Financial Express

Maintain buy on Glenmark Pharma; target Rs 1,040

Glenmark Pharma's Pithampur formulation plant has received three observations after a recent USFDA inspection. The observations appear relatively benign as they relate to inadequate controls and procedures and do not relay any data integrity issues.
 Financial Express1 week ago Glenmark Pharmaceuticals declines on receiving three observations from USFDA for Indore plant  Finalaya.com1 week ago Glenmark receives 3 observations from USFDA for Indore plant  Business Line1 week ago Glenmark Pharmaceuticals receives three observations from USFDA for Indore plant  Finalaya.com1 week ago
Money Control

USFDA issues warning letter against Polydrug Laboratories

The USFDA has issued a warning letter against Mumbai-based Polydrug Laboratories for violation of current good manufacturing practice (CGMP) in the manufacturing of active pharmaceutical ingredients (API). Citing a number of issues, including ...
 Business Standard6 days ago USFDA issues warning letter to Emcure Pharmaceuticals  Business Standard1 month ago

Glenmark Pharma gains after receiving tentative approval from USFDA for drug

Glenmark Pharmaceuticals rose 1.04% to Rs 827 at 11:20 IST on BSE after the company said its US arm has been granted tentative approval by the United States Food & Drug Administration for a generic drug. The announcement was made before market ...
 Capital Market4 days ago

E-cigarettes may do more good than harm: experts

Experts are prompting regulators at the USFDA to have a broad open-minded perspective when it comes to regulating e-cigarettes Washington: Use of vapourised nicotine products, especially e-cigarettes, may reduce overall smoking and potentially lower ...
 Livemint.com1 week ago
International Business Times India

USFDA accuses Indian clinical research firm of data fudging

U.S Food and Drug Administration said that Bangalore-based company, Semler Research has fudged data during the clinical research of drugs. epresentational Image] Reuters The United States-based drug regulator, the U.S. Food and Drug ...
 International Business Times India1 week ago Experts fear India's clinical research may get hit as global regulators spot irregularities  PharmaBiz1 day ago WHO accuses Bengaluru-based Semler Research of fraud, data manipulation  International Business Times India1 week ago German drug regulator accuses India's Alkem Laboratories of data fudging  International Business Times India2 weeks ago
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