Prequalification of Piramal’s Misoprostol API

WHO’s Prequalification of Medicines Programme prequalified a 1% Misoprostol in HPMC product from Piramal Healthcare UK Ltd, United Kingdom, on 17 December 2015 (WHOAPI-226). This product is the originator product, Piramal having taken over the Pfizer (GD Searle) manufacturing facility some years ago. Concept Foundation has assisted the company in the process and in ensuring availability of appropriate documentation for prequalification.

Pure misoprostol is an unstable oil and companies use a 1% dispersion of Misoprostol in hydroxypropyl methylcellulose (HPMC) as the active pharmaceutical ingredient (API) for manufacture of misoprostol tablets, which are used for the prevention and treatment of post-partum haemorrhage (PPH).

More information can be found on the WHO PQ website.

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