First rituximab similar biotherapeutic products prequalified
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WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
WHO Prequalification Unit – Medicines request to manufacturers to conduct risk assessments to evaluate the potential for the presence of nitrosamine impurities
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Background
Medicine Regulatory Authorities firs
First meropenem prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
First biosimilar product prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
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,
Product Recall - Moxifloxacin 100mg Dispersible Tablets (TB342): Batch BMC5801A
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On 28 May 2019, Macleods Pharmaceutical Ltd.
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.
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:
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.