04/28/2016

Anapharm Europe’s First FDA Inspections

Anapharm Europe is proud to announce that it has successfully undergone its first US FDA inspection at its Barcelona based bioanalytical lab. Anapharm Europe is also registered in accordance with FDA’s “Generic Drug User Fee Amendments of 2012” requiring “Self-Identification of Generic Drug Facilities, Sites and Organizations”. This inspections will allow Anapharm to strengthen its position in North America and continue to help its customers achieve their registration goals in the United States.

Barcelona, April 27, 2016 Anapharm Europe is proud to announce that it has successfully undergone its first US FDA inspection at its Barcelona based bioanalytical lab. Anapharm Europe is also registered in accordance with FDA’s “Generic Drug User Fee Amendments of 2012” requiring “Self-Identification of Generic Drug Facilities, Sites and Organizations”. This inspections will allow Anapharm to strengthen its position in North America and continue to help its customers achieve their registration goals in the United States. About Anapharm Europe Over the past few years Anapharm Europe has established itself as a world class provider of bioanalytical services to international Sponsors with its strategically located, GLP-certified, ANVISA certified, GCP-compliant and FDA inspected laboratory in Barcelona. With a wide experience and a successful regulatory history, Anapharm Europe has become a stable analytical partner for its clients. Anapharm Europe’s main strengths include its strong expertise for method development and extensive portfolio of validated analytical methods, its high throughput capacity, as well as its top quality performance to deliver results within rigorous timelines at competitive prices.

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12/06/2019 16:28

Anapharm Bioanalytics’ successful FDA Inspection

Anapharm Bioanalytics is proud to announce that it has successfully undergone another US FDA inspection at its Barcelona based bioanalytical lab. The inspection, that took place in June 2019, had a focus on a total of 8 studies. This was the second unannounced FDA inspection at our facilities without any observations; no 483 form issued.

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23/01/2019 10:19

Anapharm Bioanalytics has been acredited under the Gulf Health Council

Anapharm Bioanalytics is proud to announce that it has been recently added to the List of Bioequivalence Centres Approved by GCC, Gulf Cooperation Council (United Arab Emirates, Bahrain, Kingdom of Saudi Arabia, Sultanate of Oman, Qatar, Kuwait and Republic of Yemen).

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09/07/2018 11:01

Anapharm Bioanalytics Brazilian ANVISA Certificate Renewal

Anapharm Bioanalytics is proud to announce that it has recently renewed its ANVISA (Brazil) certificate.
The renewed certification is valid until 11th June 2020.

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