First sofosbuvir active pharmaceutical ingredient (API) prequalified
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Sofosbuvir (WHOAPI-290) manufactured by
Request for Proposals: Prequalification Team Quality Systems Consultancy
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The Prequalification Team is publishing a request for proposals for consultancy services relating to - developing and maintaining the Quality Management Systems (QMS) and assuming the responsibilit
Health assessment testing of human subjects in bioequivalence studies
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Applicants and Contract Research Organizations (CROs) performing bioequivalence studies are reminded that all studies with human subjects must be conducted in compliance with Good Clinical Practice
First rifapentine product prequalified
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TB336: Rifapentine - 150mg - Film-coated tablets - Sanofi-Aventis U.S. LLC - USA
5th Invitation to Manufacturers of Medicinal Products for Treatment of Neglected Tropical Diseases
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The following products were added:
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Miltefosine 10mg and 50mg capsule
BTIF revised
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The revisions to the BTIF (Bioequivalence Trial Information Form) include the following changes to facilitate study assessment:
12th Invitation for Expression of Interest (EOI) for Active Pharmaceutical Ingredients (APIs) for prequalification
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The following active pharmaceutical ingredients (APIs) were added:
- Benzathine benzylpen
11th Invitation for Expression of Interest (EOI) for Active Pharmaceutical Ingredients (APIs)
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The 11th invitation to manufacturers of active pharmaceutical ingredients (APIs) to submit an expression of interest (EOI) for API prequalification to the WHO Prequalification Team: medicines (PQTm
New EUL BDBV listing
IVD
WHO has added the BioFire Global Fever Special Pathogens Panel to the Emergency Use Listing (EUL), expanding access to a quality-assured multiplex diagnostics.
Active Pharmaceutical Ingredient (API) Prequalified
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Bedaquiline fumarate manufactured by Shanghai Neo-Leading Pharma Tech Co., Ltd.