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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07/04/2022 10:15

Anapharm Bioanalytics Brazilian ANVISA Certificate Renewal

Anapharm Bioanalytics is proud to announce that it has recently renewed its ANVISA (Brazil) certification which is now valid until February 26th, 2024.

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23/03/2022 15:12

Anapharm Bioanalytics acquires a new high sensitivity equipment: SCIEX Triple Quad 6500+ system

Anapharm Bioanalytics’ small molecule division continues to expand its capabilities with the acquisition of a new LC-MS/MS equipment tailored for method development and validation of high sensitivity assays

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28/02/2022 09:43

New UPLC-MS/MS bioanalytical method for quantification of Glycopyrronium and Indacaterol

We are glad to announce that a new method has been successfully developed and validated for determination of Glycopyrronium and Indacaterol in human plasma by LC/MS/MS with a calibration range of 1-200 pg/mL and 2-250 pg/mL, respectively.

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