Concept Foundation is delighted to report that PT Tunggal, (PTT) Indonesia has been awarded WHO Prequalification of Triclofem®, their intramuscular (IM) depot medroxyprogesterone acetate (DMPA) 150 mg/ml product. This adds a third generic DMPA product to the list...
WHO has just prequalified a combination mifepristone-misoprostol (combipack) for medical abortion
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.
A 2nd medroxyprogesterone acetate API has been prequalified by the WHO PQT, manufactured by Taizhou Taifa Pharmaceutical Co Ltd.
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.
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.
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), Concept Foundation's subsidiary laboratory in Thailand, has been prequalified by the WHO as a quality control laboratory.
The WHO PQ team has announced the prequalification of a second mifepristone product, manufactured by Exelgyn in France.
The Indian pharmaceutical company ACME Formulation Pvt. Ltd. have achieved WHO prequalification for their Misoprostol 200µg product, with technical assistance provided by Concept Foundation.