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List of Pharma Companies in India received Warning letters, Import Alert and NCR by USFDA and EDQM

List of Pharma Companies in India received Warning letters, Import Alert and Non-Compliance Reports issued by U.S. and European regulatory Agencies.

Here is the list of Indian Pharmaceutical companies received Warning letters, Import Alert and Non-Compliance Reports issued by U.S. and European regulatory Agencies in year 2015.

Company Name Regulatory Agency Regulatory Action Issue Date
Aarti Drugs Limited FDA Import Alert 23 March 2015
Akorn India PVT FDA Import Alert 21 August 2015
Apotex Research FDA Warning Letter 30 January 2015
AstraZeneca Pharma India Ltd. EDQM Non-Compliance 12 November 2015
Cadila Healthcare Limited FDA Warning Letter 23 December 2015
Dr. Reddy’s Laboratories FDA Warning Letter 11 May 2015
Dr. Reddy’s Laboratories Limited FDA Warning Letter 11 May 2015
Emcure Pharmaceuticals Limited FDA Import Alert 13 July 2015
Ipca Laboratories LTd FDA Import Alert 22 January 2015
Ipca Laboratories LTd FDA Import Alert 24 March 2015
Mahendra Chemicals FDA Warning Letter 13 July 2015
Megafine Pharma (P) Limited FDA Import Alert 14 October 2015
Micro Labs Limited FDA Warning Letter 02 September 2015
Pan Drugs Ltd FDA Warning Letter 09 February 2015
Pan Drugs Ltd FDA Import Alert 12 August 2015
Pan Drugs Ltd FDA Import Alert 05 May 2015
Parabolic Drugs EDQM Non-Compliance 28 July 2015
Polydrug Laboratories FDA Import Alert 09 November 2015
Polydrug Laboratories EDQM Non-Compliance 06 December 2015
Sharon Bio-Medicine Limited FDA Warning Letter 22 June 2015
Sipra labs FDA Warning Letter 23 July 2015
Sri Krishna Pharmaceuticals Ltd. FDA Import Alert 13 August 2015
Sun Pharmaceutical Industries Ltd. FDA Warning Letter 17 December 2015
Unimark Remedies Ltd. FDA Warning Letter 28 September 2015

 

However not only Indian Pharmaceutical companies who received Warning letters, Import Alert and Non-Compliance Reports, there are Pharma companies from other countries who also got Warning letters, Import Alert and Non-Compliance Reports by U.S. and European regulatory Agencies in year 2015.

Company Name Country Regulatory Agency Regulatory Action Issue Date
Attix Pharmaceuticals Inc. Canada FDA Warning Letter 22 June 2015
Attix Pharmaceuticals Inc. Canada FDA Import Alert 18 February 2015
Cargill France France EDQM Non-Compliance 30 October 2015
Hospira Spa Italy FDA Warning Letter 31 March 2015
Glaxosmith kline (Tianjin) China EDQM Non-Compliance 23 October 2015
Huzhou Sunflower Pharmaceutical Co., Ltd. China EDQM Non-Compliance 25 March 2015
Iason Italia srl Italy EDQM Non-Compliance 12 January 2015
Integra life science United States EDQM Non-Compliance 23 July 2015
Jinan Jinda Pharmaceutical Chemistry Co., Ltd China FDA Import Alert 25 November 2015
Jinan Jinda Pharmaceutical Chemistry Co., Ltd China EDQM Non-Compliance 28 July 2015
Mylan Laboratories Limited United States FDA Warning Letter 08 June 2015
Minsheng Group Shaoxing Pharmaceutical Co. Ltd China EDQM Non-Compliance 28 December 2015
Novacyl (Thailand) Ltd. Thailand FDA Warning Letter 27 February 2015
Relonchem Limited United Kingdom EDQM Non-Compliance 05 January 2015
Sandoz Private Limited? Germany FDA Warning Letter 22 October 2015
Syntho Pharmaceuticals, Inc. United States FDA Warning Letter 22 June 2015
Transox Inc United States FDA Warning Letter 06 August 2015
Txcell-Besacon France EDQM Non-Compliance 22 July 2015
VUAB Pharma a.s. Czech Republic FDA Warning Letter 27 May 2015
VUAB Pharma a.s. Czech Republic FDA Import Alert 04 October 2015
Wuxi Jida Pharmaceutical Co., Ltd. China EDQM Non-Compliance 28 July 2015
Wuxi Kaili Pharmaceutical China FDA Warning Letter 22 June 2015
Yunnan Hande Bio-Tech China FDA Warning Letter 04 June 2015
Zhejiang Hisun Pharmaceutical Co., Ltd China FDA Import Alert 09 September 2015
Zhejiang Hisun Pharmaceutical Co., Ltd China FDA Warning Letter 31 December 2015
Zhejiang Qianfei Enterprise Co. Ltd. China FDA Import Alert 24 November 2015
Zhuhai United Laboratories Co ., Ltd. China EDQM Non-Compliance 15 June 2015

 

 

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