Newly prequalified Active Pharmaceutical Ingredients (APIs)
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WHO Prequalification wishes to announce the prequalification of three new prequalified APIs, namely:
News
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
Eritrea joins the collaborative registration procedure
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Click here for detailed information on the Collaborative
Newly Prequalified Active Pharmaceutical Ingredients (APIs)
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Artemether (WHOAPI-268) manufactured by Chongqing Holley Wuling Mountain Pharmaceutical Co Ltd and Darunavir (ethanolate) (WHOAPI-214) ma
11th Invitation to Manufacturers of Reproductive Health Medicines to submit and Expression of Interest (EOI) for Product Evaluation by the WHO Expert Review Panel (ERP) for Reproductive Health Medicines
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The lack of prequalified reproductive health medicines is of great concern to WHO and to partner organizations working to improve reproductive health.
The Medicines Patent Pool and Pharco Pharmaceuticals Sign Licence for Promising Hepatitis C Drug Candidate Ravidasvir
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Agreement seeks to improve health options for hepatitis C patients in low- and middle-income countries.
Ajanta's artemether/lumefantrine tablet range prequalified
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WHO Prequalification Team - Medicines (PQT) added the below new products to its prequalified list
Cipla's atazanavir/ritonavir tablet prequalified
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WHO Prequalification Team - Medicines (PQT) added the below new products to its prequalified list
Micro Labs' ethionamide tablet prequalified
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WHO Prequalification Team - Medicines (PQT) added the below new products to its prequalified list
WHO prequalifies first generic active ingredient for hepatitis C medicines
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On 31 March 2017, WHO for the first time prequalified a generic active pharmaceutical ingredient (API) for hepatitis C – sofosbuvir.
4th Invitation to manufacturers and suppliers of medicinal products for treatment of hepatitis B and C to submit an expression of interest for product evaluation (EOI)
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The following products were added:
- Sofosbuvir/Velpatasvir tablet 400mg/100mg
- Velpatasvir tablet 100mg
First sofosbuvir active pharmaceutical ingredient (API) prequalified
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Sofosbuvir (WHOAPI-290) manufacture
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
13th 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:
- Azithromycin
- Miltefosine
- Paromomycin
- Sodium stibogluconate (SB5+)
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:
The Medicines Patent Pool Announces First Licence for Tuberculosis Treatment
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The Medicines Patent Pool today announced that it has signed a licence w
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 benzylpenic
8th Invitation for Expression of Interest (EOI) to manufacturers of Reproductive Health products
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The following products were added:
Treatment of maternal syphilis and prevention of congenital syphilis
Adult formulations
Newly Prequalified Active Pharmaceutical Ingredient (API)
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Medroxyprogesterone manufactured by Taizhou Taifa Pharmaceutical Co Ltd has been prequalified by the WHO Prequalification Team: medicines (PQTm) under its API prequalification procedure.
Newly prequalified Quality Control Laboratory (QCL)
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New addition to the List of Prequalified Quality Control Laboratories (QCL):
8 products newly prequalified
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WHO Prequalification Team - Medicines (PQT) added the below new products to its prequalified list
Newly Prequalified Active Pharmaceutical Ingredients (APIs)
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Cycloserine manufactured by Zhejiang Hisun Pharmaceutical Co Ltd and Zinc (sulfate) manufactured by Canton Laboratories Pvt Ltd have been prequalified by the WHO Prequalification Team: medicines (P
7 products newly prequalified
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DI005: Zinc (as sulfate monohydrate) - 20mg - Dispersible tablets - Macleods Pharmaceuticals Ltd - INDIA
Misoprostol from China Resources Zizhu Pharmaceutical prequalified
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RH048: Misoprostol - 200µg - Tablets - China Resources Zizhu Pharmaceutical Co Ltd - CHINA
Newly Prequalified Active Pharmaceutical Ingredient (API)
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Dihydroartemisinin manufactured by Ipca Laboratories Ltd has been prequalified by the WHO Prequalification Team: medicines (PQTm) under its API prequalification procedure.
2 products newly prequalified
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WHO Prequalification Team - Medicines (PQT) adds the below new products to its prequalified list
2 products newly prequalified
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WHO Prequalification Team - Medicines (PQT) adds the below new products to its prequalified list