WHO has just prequalified a combination mifepristone-misoprostol (combipack) for medical abortion
New generic IM DMPA available for procurement
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Mylan Laboratories Limited has received a risk category 1 ranking from the WHO Expert Review Panel for its generic injectable, medroxyprogesterone acetate depot 150mg/ml.
Expansion of available prequalified MPA API
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A 2nd medroxyprogesterone acetate API has been prequalified by the WHO PQT, manufactured by Taizhou Taifa Pharmaceutical Co Ltd.
Fourth Misoprostol product prequalified by WHO PQ
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The World Health Organisation Prequalification team have announced the prequalification of a fourth generic misoprostol 200μg product, manufactured by China Resources Zizhu Pharmaceutical Co. Ltd.
New Financing Model Announced for WHO Prequalification of Medicines and Vaccines
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At the end of last month, the WHO announced the implementation of a new financing model for their Prequalification programme, to take effect in January 2017. The detailed scheme and other questions and answers that any manufacturers may have are also available on the WHO website.
3 reproductive health medicines prequalified, including first magnesium sulfate product
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turned_in_notLevonorgestrel, magnesium sulfate, maternal health, mifepristone, technical assistance, WHO PQ
Inresa Arzneimittel GmbH have achieved WHO prequalification on 15 August 2016 for their magnesium sulfate heptahydrate (MgSO4) 500 mg/ml injection with technical assistance from Concept Foundation. This is the first such product to be prequalified.
On the same day, China Resources Zizhu have had their mifepristone 200mg product added to the list of WHO prequalified medicines for use in combination with misoprostol, as have Jai Pharma Ltd with their levonorgestrel 0.03mg progestin-only contraceptive.
Health Concepts International (HCI) is WHO prequalified
Health Concepts International (HCI), Concept Foundation’s subsidiary laboratory in Thailand, has been prequalified by the WHO as a quality control laboratory.
Second Mifepristone product prequalified by WHO PQ
The WHO PQ team has announced the prequalification of a second mifepristone product, manufactured by Exelgyn in France.
ACME has Misoprostol product prequalified by the WHO
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The Indian pharmaceutical company ACME Formulation Pvt. Ltd. have achieved WHO prequalification for their Misoprostol 200µg product, with technical assistance provided by Concept Foundation.
Pilot collaborative registration procedure for SRA-approved medicines
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The WHO PQ has announced a pilot collaborative registration procedure for SRA-approved medicines. Products being included in this pilot are medicines for HIV, TB, and antimalarials, as well as RH products such as contraceptives and maternal health medicines.
News & Events
- WHO Prequalifies a 2nd generic DMPA product with Concept Foundation support
- WHO has just prequalified a combination mifepristone-misoprostol (combipack) for medical abortion
- WHO has just prequalified a combination mifepristone-misoprostol (combipack) for medical abortion
- A third quality assured, generic DMPA-IM product available for procurement
- From Concept Foundation: July 2019