New WHO Public Assessment Report (WHOPAR) published
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News
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 benzylpen
Newly prequalified Quality Control Laboratory (QCL)
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New addition to the List of Prequalified Quality Control Laboratories (QCL):
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.
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
8 products newly prequalified
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WHO Prequalification Team - Medicines (PQT) added the below new products to its prequalified list
7 products newly prequalified
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DI005: Zinc (as sulfate monohydrate) - 20mg - Dispersible tablets - Macleods Pharmaceuticals Ltd - INDIA
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
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
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
14th Invitation for Expression of Interest (EOI) for antituberculosis medicines published
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The following products were added to the EOI:
New TB product prequalified
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WHO Prequalification Team - Medicines (PQT) added the below new product to its prequalified list:
Newly-prequalified active pharmaceutical ingredient (API)
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Levofloxacin manufactured by Shangyu Jingxin Pharmaceutical Co Ltd has been prequalified by the WHO Prequalification Team: medicines (PQTm) under its API prequalification procedure.
3 products newly prequalified
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WHO Prequalification Team - Medicines (PQT) added the below new products to its prequalified list
Second diethylcarbamazine prequalified
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WHO Prequalification Team - Medicines (PQT) added the below new product to its prequalified list:
Newly-prequalified active pharmaceutical ingredients (APIs)
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Lumefantrine manufactured by Micro Labs Ltd and Lopinavir manufactured by Acebright (India) Pharma Pvt Ltd have been prequalified by the WHO Prequalification Team: medicines (PQTm) under its API pr
4 products newly prequalified
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WHO Prequalification Team - Medicines (PQT) added the below new products to its prequalified list