New WHO Public Inspection Reports (WHOPIRs) published
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Past News
Revised Appendix for Bioequivalence Trial Information (BTIF)
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In September 2018, an appendix was added to the Bioe
First co-pack of mifepristone oral tablet and misoprostol for vaginal administration prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Levofloxacin 750mg tablets prequalified
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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
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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
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Dolutegravir/lamivudine/tenofovir tablets prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
WHO launches first-ever insulin prequalification programme to expand access to life-saving treatment for diabetes
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The World Health Organization (WHO) today announced the start of a pilot programme to prequalify human insulin to increase treatment for diabetes in low- and middle-income countries.
WHO prequalifies Ebola vaccine, paving the way for its use in high-risk countries
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The World Health Organization (WHO) today prequalified an Ebola vaccine for the first time, a critical step that will help speed up its licensing, access and roll-out in countries most at risk of E
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.
Krka’s darunavir 600mg 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:
Sun’s abacavir/lamivudine tablet prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
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:
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.