• New approval breaks the single-source supply bottleneck, improving affordability for health systems in low- and middle-income countries.
• Millions more women will gain access to a discreet, convenient contraceptive they can use on their own terms.

(October 3rd, 2025) – The World Health Organization (WHO) has issued its first-ever prequalification approval for a generic version of subcutaneous depot medroxyprogesterone acetate (DMPA-SC), developed by Incepta Pharmaceuticals’ under the brand, Medogen SubQ. 

DMPA-SC was originally developed and launched by Pfizer over a decade ago under the brand name, Sayana Press.  DMPA-SC is a three-month injectable contraceptive that can be administered by health workers or self-injected after appropriate training. Especially valued by users for its discretion, convenience, and empowerment potential, it can help overcome traditional barriers to contraceptive use, yet access remains limited in many low-resource settings. 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.  

With support from the Children’s Investment Fund Foundation (CIFF) and the Gates Foundation, Incepta’s Medogen SubQ will give countries another trusted supplier and help make the product more affordable for health systems. This means women who want to use contraception, especially in places where access is limited, will have more options and a more reliable supply. 

More than 250 million women globally, primarily in low- and middle-income countries (LMICs), still have an unmet need for modern contraception1. Diversifying supply of convenient, accessible methods like DMPA-SC is vital to expanding contraceptive choice, improving access in hard-to-reach areas, and supporting innovative self-care approaches. 

 “This is a welcome development for Uganda, where unmet need for family planning remains high, especially among young women, said Dr. Charles Olaro, Director General Health Services, Ministry of Health Uganda. “The availability of a WHO prequalified generic DMPA-SC brings much needed diversity to the market and will support our national total market approach efforts to expand access to self-care across the country.”  

“Affordability, choice, and access are fundamental to rights-based family planning. WHO prequalification marks a major step forward in increasing the availability of quality-assured contraceptive options that meet the reproductive health needs of women and girls on their own terms, especially  in the most remote and underserved areas” said Dr. Pascale Allotey, Director of the Department of Sexual Reproductive Health and Research (SRH) and the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP) at WHO 

“Affordable, quality contraceptives are fundamental to women’s reproductive autonomy. Today’s announcement will expand contraceptive choice for the millions of women and girls who need it most. Countries are already leading the way. In 2024, 49 countries procured DMPA-SC through UNFPA, and 37 countries in the UNFPA Supplies Partnership rolled out self-administration of DMPA-SC. Now we can achieve even more – securing supplies, ensuring access, and upholding the rights of every woman to make informed reproductive choices for herself.” — Julia Bunting, Director, Programme Division, UNFPA  

“The prequalification of Incepta’s DMPA-SC is a major step towards increasing access to high-quality, affordable contraception and a range of options to choose from,” said Miles Kemplay, Executive Director, Sexual and Reproductive Health and Rights at CIFF. “Today, millions of women opt for self-injectable contraception, because it saves time and money, and removes access barriers.”   

This milestone builds on sustained efforts to ensure access to contraception for women who want it in LMICs. 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. 

“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.” 

Inside the Incepta facility, where the first generic 3-monthly self-injectable contraceptive (DMPA-SC) is being manufactured.

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 the Children’s Investment Fund Foundation (CIFF) 

CIFF is an independent philanthropic organisation that partners with governments, communities and institutions to create systemic, locally-owned change and in turn, a world where all children flourish.  

CIFF has over $3 billion actively invested in projects and people who are accelerating solutions to the world’s interlinking problems: tackling climate change, improving health and nutrition, and promoting opportunities and choice for women and girls.  

About the Gates Foundation 

Guided by the belief that every life has equal value, the Gates Foundation works to help all people lead healthy, productive lives. In developing countries, we work with partners to create impactful solutions so that people can take charge of their futures and achieve their full potential. In the United States, we aim to ensure that everyone—especially those with the fewest resources—has access to the opportunities needed to succeed in school and life. Based in Seattle, Washington, the foundation is led by CEO Mark Suzman, under the direction of Bill Gates and our governing board.