Past News
First primaquine prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Zydus’ daclatasvir products prequalified
WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
Svizera’s isoniazid 300 mg tabl prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Aurobindo’s molnupiravir prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Zhejiang Huahai’s nirmatrelvir + ritonavir prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Shouguang Fukang’s sulfamethoxazole/trimetoprim tablets prequalified
WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
Cipla’s molnupiravir prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
S Kant’s pyridoxine tablet prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequal
First products for Ebola Virus Disease prequalified
WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
First bedaquiline product prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
- TB396 - Bedaquiline fumarate - 100mg - Tablet - Lupin Ltd - INDIA
First paediatric abacavir/dolutegravir/lamivudine 60mg/5mg/30mg dispersible tablet prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequal
Zhejiang Apeloa Kangyu’s nirmatrelvir + ritonavir tablet prequalified
WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
Vaccines prequalification prioritity list 2024-2026
For more information click here
10th Invitation to manufacturers of reproductive health products to submit an expression of interest (EOI) for product evaluation to the WHO Prequalification Team: medicines
Addition:
Under section: 9. Antifibrinolytics
22nd Invitation for Expression of Interest (EOI) to manufacturers of antimalarial medicines published
New Invitation for Expression of Interest (EOI) to manufacturers of antimalarial medicines published
Addition:
Newly prequalified Active Pharmaceutical Ingredient (API)
Molnupiravir (WHOAPI-449) manufactured by Shanghai Desano Chemical Pharmac
Newly prequalified Active Pharmaceutical Ingredient (API)
Molnupiravir (WHOAPI-438) manufactured by Optimus Drugs Pvt Ltd, has been
Huayi’s sulfamethoxazole/trimethoprim tablets prequalified
WHO Prequalification Unit (PQT) added the below new products to its prequa
WHO Prequalification Team - Medicines (PQT/MED) has issued new guidance on the recommended style to be used for visual description of oral dosage forms in WHO Public Assessment Reports (WHOPARs)
WHO Prequalification Team - Medicines (PQT/MED) has issued a new guidance on the recommended style to be used for visual description of oral dosage forms in WHO Public Assessment Reports
Beijing Holley-Cotec’s DHA/piperaquine tablet prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Celltrion’s nirmatrelvir + ritonavir tablet prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Update on N-nitrosamine impurities
Applicants are reminded of the latest N-nitrosamines assessment policies for active pharmaceutical ingredients (APIs) and finished pharmaceutical products (FPPs):
Newly prequalified Active Pharmaceutical Ingredient (API)
Nirmatrelvir (WHOAPI-469) manufactured by Shanghai Desano Chemical Pharmaceutical Co Ltd, has been prequalified by the WHO Prequalification Team: Medicines under its API prequalification procedure.
Ipca’s higher strength artesunate injection prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
First rifapentine generic prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Micro Labs’ paediatric linezolid tablet prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Laurus’ atazanavir/ritonavir tablet prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Micro Labs’ lopinavir/ritonavir, including paediatric tablet, prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Human Insulin Master File (h-IMF)
Diabetes mellitus is a public health challenge due to its high and increasing prevalence and associated morbidity and mortality that have health and economic impact on ind