New WHO Public Inspection Reports (WHOPIRs) published
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News
Nitrosamine contamination – Recent international alerts
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The WHO Prequalification Team (PQT) is aware, and monitoring closely, announcements by major regulators regarding the presence of nitrosamine impurities in batches of sartan-related products,
WHO signs MoU with International Generic and Biosimilar Medicines Association to promote access
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Full access to medicines is hampered by a variety o
Micro Labs’ 100mg dispersible levofloxacin tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Guidance on amendments has been revised
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The guidance document on amendments to an Active Pharmaceutical Ingredient Master File (APIMF) submitted in support of a Prequalified Pharmaceutical Product (FPP) or Prequalified Active Pharmaceuti
Laurus’ dolutegravir prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Oxytocin injections prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Product Recall - Moxifloxacin 100mg Dispersible Tablets (TB342): Batch BMC5801A
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On 28 May 2019, Macleods Pharmaceutical Ltd.
Mylan’s darunavir 600mg and 800mg tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Sun’s abacavir/lamivudine tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Unique’s ciprofloxacin tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Krka’s darunavir 600mg tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Macleods’ streptomycin injection prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
First generic daclatasvir prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Macleods’ amodiaquine/artesunate tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
MSN’s levofloxacin tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Micro Labs’ lamivudine/nevirapine/zidovudine tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Information on the GMP status of Micro Labs Kumbalgodu (ML08) manufacturing facility
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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
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Cipla’s dolutegravir/lamivudine/tenofovir tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
Mylan’s sulfamethoxazole/trimethoprim tablet prequalified
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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
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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
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The following products were added:
Getz’ moxifloxacin tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list:
PT Kalbe Farma’s levofloxacin tablet prequalified
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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
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The 6th NTD EOI adds fexinidazole for Human African trypanosomiasis (HAT) and clarifies the scabies indication for ivermectin.
First sofosbuvir/velpatasvir prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new products to its prequalified list: