News
First meropenem prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Strides’ sofosbuvir 400 mg tablet prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Emcure’s dolutegravir 50 mg tablet prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Incepta’s medroxyprogesterone injection prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Shanghai Harvest Pharmaceutical’s kanamycin injection prequalified
WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
Lupin’s emtricitabine/tenofovir tablet prequalified
WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
WHO publishes Emergency Use Listing procedure and roadmap to make new medical products more readily available during health emergencies
WHO published the Emergency Use Listing (EUL) procedure to streamline the process by which new or unlicensed products can be used during public health emergencies.
7th Invitation to manufacturers of medicinal products for treatment of Neglected Tropical Diseases (NTDs), to submit an Expression of Interest (EOI) for product evaluation to the WHO Prequalification Unit
Products added under:
Singl
Launch of pilot programme for international cooperation in GMP inspections of manufacturers of sterile medicinal products for human use
International collaboration in the inspection of manufacturers of active pharmaceutical ingredients has been beneficial over the last few years (1).
Hetero’s dolutegravir/lamivudine/tenofovir tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
First biosimilar product prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Lupin’s lamivudine/tenofovir 300mg/300mg tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Teva’s generic atazanavir prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
First co-blister of daclatasvir/sofosbuvir prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Cipla’s 30mg and 60mg daclatasvir tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Hetero’s daclatasvir 30mg and 60mg tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Roche sulfamethoxazole/trimethoprim prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Celltrion’s lamivudine/tenofovir tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Sun’s dolutegravir/lamivudine/tenofovir tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Milan’s sulfamethoxazole/trimethoprim tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Clarifications regarding carton-free supply of prequalified products packaged in bottles
PQTm acknowledges the advantages of carton-free supply of medicinal products that are presented in bottle packs and therefore support initiatives for carton free packaging being promoted by various
Clarifications regarding carton-free supply of prequalified products packaged in bottles
PQTm acknowledges the advantages of carton-free supply of medicinal products that are presented in bottle packs and therefore support initiatives for carton free packaging being promoted by various
Revised Appendix for Bioequivalence Trial Information (BTIF)
In September 2018, an appendix was added to the Bioe
First co-pack of mifepristone oral tablet and misoprostol for vaginal administration prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Levofloxacin 750mg tablets prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Guilin’s DHA/piperaquine 40mg/320mg and 20mg/160mg dispersible tablets prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Guilin’s DHA/piperaquine 40mg/320mg and 80mg/640mg tablets prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list: