A milestone towards advancing full reproductive agency for women across the world: WHO grants prequalification to first generic self-injectable contraceptive, increasing access to high-quality contraceptive choices

(October 7^th, 2025) – In a move to advance women’s agency when it comes to contraceptive choice and reproductive health, Incepta Pharmaceuticals has developed the first-ever WHO prequalified generic version of subcutaneous depot medroxyprogesterone acetate (DMPA-SC) under the brand, Medogen SubQ.

Globally, over 250 million women, primarily in low-and middle-income countries (LMICs), still have an unmet need for modern contraception. This gap can be attributed to various factors including stigma, affordability, limited awareness and accessibility of modern contraceptive methods. DMPA-SC presents a unique opportunity to increase reproductive access and agency for women and girls.

Originally developed and launched by Pfizer under the brand name, Sayana Press, DMPA-SC is a three-month advanced, safe, easy to use and reversible self-injectable contraceptive that expands family planning options for women and girls. Incepta is actively pursuing local registration in more than 60 countries, thereby offering women and girls increased reproductive autonomy through a discrete, convenient, and easily accessible contraceptive option. This subsequently increases their chances at better educational and employment opportunities. WHO prequalification is a rigorous global quality stamp that signals a medicine meets international standards for safety, effectiveness, and manufacturing. This is a critical milestone for ensuring DMPA-SC reaches all women who wish to use it.

Access to reproductive health is dependent on affordability. The current cost of the existing self-injectable contraceptive is prohibitive for many countries and requires donor support for increased access. Incepta’s introduction of a low-cost generic product, Medogen SubQ, gives countries another trusted supplier and helps make the product more affordable for national governments. This means women who want to use contraception, especially in places where access is limited, will have more options and a more affordable and reliable supply.

With support from the Children’s Investment Fund Foundation (CIFF) and the Gates Foundation, Market Access Africa has been working with Incepta on Medogen SubQs commercialization strategy and product launch planning. This support has been critical in enabling Incepta Pharmaceuticals to achieve their WHO PQ approval and ensuring market readiness for product launch in low-, middle- and upper-income countries.

“This milestone contributes to a shared vision of equitable access to innovative health products for all,” said Olawale Ajose, Managing Partner at Market Access Africa. “By bringing more choices, we are enhancing women’s autonomy when it comes to their reproductive health; we are giving women and girls a choice — conveniently and affordably.”

“We are proud to have achieved WHO prequalification for our DMPA-SC product,” said Abdul Muktadir, Chairman and Managing Director of Incepta Pharmaceuticals. “This accomplishment reflects our commitment to advancing public health and making essential medicines accessible to women across the world. We look forward to working with global partners to bring this product to market and improve reproductive health outcomes at scale.” 

This milestone builds on collective efforts by donors and implementing partner to ensure access to contraception for women who want it inLMICs. By supporting Incepta to develop a WHO prequalified generic DMPA-SC, the partners aim to make the product more affordable for public health programs and ensure that countries aren’t reliant on a single supplier.

About DMPA-SC

Depot medroxyprogesterone acetate administered subcutaneously (DMPA-SC) is a progestin-only, subcutaneous contraceptive injection that provides three months of protection from unintended pregnancy DMPA-SC can be self-injected, administered by community health workers, or provided by healthcare professionals. DMPA-SC is considered highly effective at preventing pregnancy.

About Incepta Pharmaceuticals

Incepta Pharmaceuticals Ltd. is a leading pharmaceutical company based in Bangladesh with a strong record of innovation, affordability, and public health commitment. Incepta produces a wide range of high-quality generic medicines and vaccines, and its growing portfolio of WHO-prequalified products including a DMPA-IM (intra-muscular) product that requires administration from a trained health provider, and supports health systems globally. More at: www.inceptapharma.com

About Market Access Africa‍

Market Access Africa is a mission-driven healthcare organisation working to close access gaps for essential health products and services across Africa.

Media Contact:

Krystal Mtasa

Associate, Communication and Partnerships

kmtasa@marketaccess.africa