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Total 14 results found. Search for [ FDA's warning letter ]

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PB Jayakumar
November 6, 2019
Most violations relate to rectifiable documentation, data maintenance, batch-wise consistent production quality, data on supply chain, stability issues, microbial contamination and quality checks


BusinessToday.In
October 11, 2019
Cipla share price has lost 2.51% in last 2 days. The US drug regulator carried out inspection from September 16-September 27 in the Goa unit of the firm.  It has subsequently issued form 483 comprising 38 pages which carries 12 observations for the Cipla's Goa facility.


Reuters
July 17, 2019
The U.S. Food and Drug Administration (FDA) said it found adulteration and \"significant violations\" of current good manufacturing practice (CGMP) regulations at Strides Pharma Sciences Ltd's plant in Puducherry in south India.


BusinessToday.In
New Delhi, March 26, 2019
In the last five trading session, shares of the company declined as much as 22.93 per cent on the BSE since March 19, which was Rs 843.35.


Reuters
December 15, 2018
Asbestos that allegedly lurked in J&J's Baby Powder causes mesothelioma and is linked with ovarian and other cancers


Reuters
December 7, 2016
The approval of several of Sun's key drugs in the United States, the drugmaker's biggest market, depends on the clearance on its Halol plant in Gujarat. A warning letter issued by the US Food and Drug Administration (FDA) last year over violations found at the plant has already been hurting the company's sales.


E Kumar Sharma
October 10, 2016
Leading global consultancy firms like Lachman Consultants, Parexel and Quintiles (now QuintilesIMS), have been in demand in India with pharmaceutical companies seeking their services to resolve regulatory compliance issues.


By E. Kumar Sharma
Delhi, March 3, 2016
Many believe that it is pressure from a section of the US pharma giants who see their market shrinking that has prompted the USFDA's excessively suspicious approach towards them.


PB Jayakumar
December 31, 2015
The latest is Ahmedabad-based Zydus Cadila. In the past few months, Sun Pharma's two plants and Dr Reddy's three plants had received warning letters from the drug regulator for quality issues. Ranbaxy, now part of Sun Pharma, and Wockhardt are under the FDA scanner for the past few years.


E Kumar Sharma
December 18, 2015
Till end of November, over 170 inspections were held in India as against over 70 inspection and certainly much less than 100 conducted five years ago by the US regulator in India.


PTI
New Delhi, August 19, 2015
The US regulator said its inspectors found significant violations in the three manufacturing facilities in Bengaluru, which is an arm of US-based Mylan Inc. Of the three units, two plants belonged to Agila Specialties, which Mylan had acquired from Strides Arcolab in 2013-end. The other unit is owned by Mylan Laboratories.


E. Kumar Sharma
January 27, 2015
Of the 19 warning letters issued by the office of manufacturing and product quality of the FDA in 2014, seven were issued to Indian companies and one to an India facility of a Canada-based company.


Reuters
Mumbai, September 13, 2013
Increased on-the-ground oversight reflects India's growing importance as a supplier to the United States, and should ultimately bolster quality and confidence in Indian-made drugs.


Suman Layak
November 13, 2008
It has been a great 12 months for Sun Pharmaceutical Industries and an even better first half for 2008-09. The company has reported a 76 per cent year-on-year growth in sales and a 134 per cent growth in net profits for the quarter ended on September 30, 2008. Suman Layak says that it stays ahead of the pack with a clear focus on consistency, profitability and some clever moves in its main market, the US.


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