Status of COVID-19 Medicines and Active Pharmaceutical Ingredients (APIs) updated
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News
Hetero’s praziquantel 600mg tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Strides' dolutegravir 50mg tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Universal’s pyrimethamine/sulfadoxine dispersible tablet prequalified
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WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
Desano’s atazanavir/ritonavir tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
New Ag RDT added to WHO EUL listing
IVD
On 18 July 2022 the Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) was added to WHO EUL listing.
WHO issues its first emergency use listing for a SARS-CoV-2 self-test
IVD
Today, WHO listed the first quality-assured SARS-CoV-2 self-test for emergency use.
Desano’s efavirenz/lamivudine/tenofovir tablets prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Newly prequalified Active Pharmaceutical Ingredients (APIs)
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Pyronaridine (phosphate) (non-micronised: WHOAPI-405a and micronised: WHOAPI-405b) manufactured by Mangalam Drugs & Organics Ltd has been prequalified by the WHO Prequalification Unit - Medicin
Nitrosamine concerns in rifapentine products - Update
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As previously announced, the nitrosamine impurity, 1-cyclopentyl-4-nitrosopiperazine (CPNP), has been identified in rifapentine products.
Mylan’s Isoniazid/Pyridoxine hydrochloride/Sulfamethoxazole/Trimethoprim prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
SAVE THE DATE - Joint UNICEF-UNFPA-WHO Meeting with Manufacturers and Suppliers
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On behalf of the United Nations Children Fund (UNICEF), the United Nations Population Fund (UNFPA) and the World Health Organization (WHO), we invite you to save the date for the 2022 Joint UNICEF-
Request for Proposals - Establishment of a WHO PQ technical evaluation specifications and protocols for the performance evaluation of computer-aided detection software for tuberculosis and other medical devices
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The purpose of this Request for Proposals (RFP) is to identify a suitable contractor to establish a WHO PQ technical evaluation specifications and protocols for the performance evaluation of comput
Invitation to Laboratories to Submit an Expression of Interest in Becoming a Performance Evaluation Laboratory for TB Nucleic Acid Tests
IVD
Laboratories with experience in conducting independent performance evaluation of in vitro diagnostics (IVDs) are invited to submit an Expression of Interest (EOI) to become a Performance Evaluation
New Performance Evaluation Laboratories
IVD
Two laboratories were added to the list of Performance Evaluation Laboratories (PEL) :
First carbetocin prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list: