News
Information on the GMP status of Micro Labs Kumbalgodu (ML08) manufacturing facility
A Good Manufacturing Practice (GMP) inspection of Micro Labs Ltd., Kumbalgodu (ML08) was carried out by the World Health Organization 27-31 August 2018.
First mebendazole prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Cipla’s dolutegravir/lamivudine/tenofovir tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Mylan’s sulfamethoxazole/trimethoprim tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Frequently Asked Questions (FAQ) - WHO Pilot Procedure for Prequalification of Biotherapeutic Products: rituximab and trastuzumab
This is the first Q&A on biotherapeutic/similar biotherapeutic products (BTP/SBP) based on the experience of rituximab and trastuzumab applications in the ongoing BTP/SBP pilot prequalification
9th Invitation to manufacturers of reproductive health products to submit an expression of interest (EOI) for product evaluation to the WHO Prequalification Team: medicines
The following products were added:
Getz’ moxifloxacin tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
PT Kalbe Farma’s levofloxacin tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
6th Invitation to Manufacturers of Medicinal Products for Treatment of Neglected Tropical Diseases, to Submit an Expression of Interest (EOI) for Product Evaluation to the WHO Prequalification Team: medicines
The 6th NTD EOI adds fexinidazole for Human African trypanosomiasis (HAT) and clarifies the scabies indication for ivermectin.
First sofosbuvir/velpatasvir prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Strides' artemether/lumefantrine tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Livzon’s kanamycin solution for injection prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Celltrion’s linezolid tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
16th Invitation to manufacturers and suppliers of medicinal products for HIV infections and related diseases to submit and Expression of Interest (EOI) for product evaluation to the WHO Prequalification Team: medicines
The following products were deleted:
Mylan’s kanamycin prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Beximco’s lamivudine tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
First FDC with dolutegravir prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Anhui's lamivudine/zidovudine tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Unique's ciprofloxacin prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
EEPI's sofosbuvir prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Guilin's artesunate + SP tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Lupin's linezolid prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Macleods' paediatric moxifloxacin dispersible tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Ipca's artesunate injection prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Emergency Use Listing Procedure - Deadline extended to 15 December 2018
DEADLINE EXTENDED TO 15 DECEMBER 2018
First generic medroxyprogesterone injection prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
First 800mg darunavir tablet prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
First efavirenz/lamivudine/tenofovir 400/300/300mg tablets prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
First moxifloxacin 100mg dispersible tablets prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Zheijiang Hisun’s moxifloxacin tablets prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Micro Labs’ linezolid tablets prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Micro Labs’ amodiaquine/artesunate tablets prequalified
WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list: