Zarin Contraceptive Implant Launched in Kenya -- January 30, 2009

NAIROBI, Kenya — Distribution of Zarin contraceptive implant in Kenya was formally launched today by Pharm Access Africa Limited, Family Health International, and Shanghai Dahua Pharmaceutical Company Limited. Pharm Access Africa Limited was awarded exclusive distribution rights for Zarin contraceptive implant in 11 African countries, under an agreement between the three companies.

The introduction of Zarin to sub-Saharan Africa should increase access to contraceptive implants in the region by providing a more affordable product. Zarin will cost 70 percent less than other contraceptive implants, which should greatly increase the use and distribution of this highly effective family-planning method. The low price includes a single-use trocar — a crucial benefit in countries with a high prevalence of HIV because there is no need for sterilization equipment. (The trocar is used to insert the implant under the skin of the upper arm.)

Despite its low cost, Zarin will be manufactured to the highest standards of quality. The product's manufacturer, Shanghai Dahua Pharmaceutical Company Limited, complies with international Good Manufacturing Practices (GMP), and the company's new manufacturing facility meets the ISO 9001 and ISO 13485 standards. On August 27, 2008, the Pharmacy and Poisons Board of Kenya approved Zarin for distribution inside the country. This approval followed their review of regulatory and clinical documentation and independent product testing by the National Quality Control Laboratory in Nairobi. The facility received a GMP certificate the previous month after an audit by the Board. Every lot of Zarin will be tested during production by an independent laboratory to monitor its quality. Family Health International has a five-year grant to ensure that the quality of Zarin is maintained.

Family Health International is assisting Shanghai Dahua Pharmaceutical Company Limited to seek prequalification of Zarin by the World Health Organization (WHO) to accelerate worldwide registration efforts. If successfully prequalified by WHO, Zarin would be the first contraceptive product to achieve that status.

Family Health International (FHI) works to address key public health and development needs in developing countries, including family planning, child and maternal health, infectious diseases such as HIV/AIDS, malaria and tuberculosis, and chronic conditions such as cardiovascular disease. FHI also works to strengthen broader health systems.

Shanghai Dahua Pharmaceutical Company Limited is registered by the China State Food and Drug Administration and designated by the State Population and Family Planning Commission for the manufacture of contraceptive products. The company has produced and distributed more than six million implants.

Pharm Access Africa Limited (PAAL) is a healthcare organization that enhances access to health services for the 292 million people of Eastern and Central Africa. PAAL provides technical assistance to public sector programs, develops public/private partnerships, and links public/private sector initiatives to the goals of donor organizations.