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.
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
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The following products were deleted:
Emergency Use Listing Procedure - Deadline extended to 15 December 2018
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DEADLINE EXTENDED TO 15 DECEMBER 2018
WHO kick-starts pilot prequalification of biotherapeutics for cancer treatment
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WHO today launches a pilot project for prequalifying biotherapeutic medicines, a step towards making some of the most expensive treatments for cancer more widely available in low- and middle-income
UPDATE: WHO Position paper on Qinhuangdao Zizhu Pharmaceutical Co Ltd, Active Pharmaceutical Ingredient (API) manufacturing site following the issue of the USFDA import alert
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On 07 April 2017, WHO issued a position paper on the import alert placed on, Qinhuangdao Zizhu Pharmaceutical (QZP) by the United States Food and Drug Administration (USFDA) on 8 March 2017. This
Pre-submission meetings
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Pre-submission meetings provide an opportunity for advice and guidance prior to submission of a medicines dossier, as well as an opportunity for the applicant to meet the PQT medicines (PQTm) asses