Assessment of response to position paper "WHO response to the USFDA warning letter issued to Mylan Laboratories Ltd, Nashik"
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15th Invitation to manufacturers and suppliers of medicinal products for HIV infections and related diseases to submit and Expression of Interest (EOI) for product evaluation to the WHO Prequalification Team: medicines
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The following products were added:
- Lamivudine/Abacavir/Dolutegravir, tablet 30mg/60mg/5mg dispersible
WHO to begin pilot prequalification of biosimilars for cancer treatment
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This year WHO will launch a pilot project for prequalifying biosimilar medicines, a step towards making some of the most expensive treatments for cancer more widely available in low- and midd
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