PT Tunggal, Indonesia, achieves WHO Prequalification of its intra-muscular injectable contraceptive Triclofem®.

Aug 16, 2021 | Concept Foundation, Family Planning, Global news, Quality, QuRHM, Reproductive health news, WHO PQ

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 of WHO Prequalified intramuscular DMPA products, significantly increasing the global manufacturing capacity for supply of lower cost, quality assured injectable contraception in low and middle income countries (LMIC) markets, bringing us closer to ensuring universal access to quality, affordable essential sexual and reproductive health medicines. Globally, injectable contraception remains one of the most commonly used pharmaceutical methods of modern contraception after the oral pill, with a significant portion of this usage being in sub-Saharan Africa.

PTT has held UNFPA ERP category 2 since December 2018 which has facilitated short term supply of Triclofem® to selected LMIC markets to date. This supply can now be sustained and expanded long-term with the WHO PQ approval. PTT holds large market presence in its domestic market as well exporting internationally including some sub-Saharan African markets. This result also supports the ongoing Family Planning 2030 movement’s goal of expanding access to modern contraception to an additional 120 million women and girls in the 69 Family Planning 2020 countries.

Since 2012, Concept Foundation has been working in collaboration with PTT to gain WHO PQ approval, initially with funding from the Bill and Melinda Gates Foundation (BMGF) under its programme “Addressing the barriers to making quality assured 3 monthly injectable contraception more widely available”, a programme focused around engagement with the manufacturing industry and designed to accelerate and increase the availability of generic quality assured injectable contraception that could be supplied affordably in high need LMIC markets.