Zarin Contraceptive Implant

A low-cost, safe, and effective contraceptive implant

Zarin® , also known as Sino-implant (II), is a subcutaneous contraceptive implant manufactured in China by Shanghai Dahua Pharmaceutical Co., Ltd. The implant is composed of two thin, flexible rods made of medical grade silicone each containing 75 mg levonorgestrel (a synthetic progestin). Each rod consists of the drug core and an external medical silastic tube sealed at both ends with medical adhesive. The implant is inserted under the skin in the upper arm.

Zarin has the same mechanism of action as Jadelle. Like other contraceptive implants, Zarin is one of the most highly effective contraceptive methods with an annual pregnancy rate below 1%. Clinical trials published in peer-reviewed journals with a total of more than 11,800 women followed for up to five years show Zarin to be safe and effective. The implants are currently labeled for four years of use.

Zarin has been available in China since 1994, and has been routinely exported to Indonesia during the past five years. To date, six million units of Zarin have been distributed.

Shanghai Dahua Pharmaceutical Co. Ltd.

Shanghai Dahua Pharmaceutical Company Limited. is an enterprise 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 current manufacturing facility opened in 2004 and was specifically designed and built to meet China Good Manufacturing Practice (GMP) standards.

Built for the manufacture of contraceptive products
GMP Certificate of the People’s Republic of China
ISO 9001 and ISO 13485 certified: National Quality Institute (NQI, UK)
Six million implants distributed

Ongoing Product Quality Evaluation

Quality evaluation of Zarin is being performed to ensure the product quality. The initial evaluation of several manufacturing lots confirmed that Zarin met lot release specifications. Each lot was tested, according to the Chinese Pharmacopeia testing methods, at FHI’s Product Quality and Compliance laboratory and by an independent contract laboratory.

Lot release testing verification will continue for the next five years prior to export to any country where Zarin is registered as part of this FHI-led initiative.

In parallel with the product quality evaluation, a series of independent GMP audits by qualified and trained auditors have begun to be implemented to provide assurance of Shanghai Dahua Pharmaceutical’s compliance with GMP’s.

Zarin has been successfully registered in Kenya & Shanghai Dahua inspected by Drug Regulatory Authorities. Registration in other African countries is currently underway.

shanghai meeting

Exclusive Distribution Rights and Public Sector Pricing

FHI is the Global Coordinating Center of the Sino-implant (II) subdermal contraceptive implant. FHI facilitates negotiation of six-year contracts between Shanghai Dahua Pharmaceutical and prospective partners to purchase Sino-implant (II) at a low price. These contracts will provide partners with exclusive distribution rights.

In return, partners with exclusive distribution agreements guarantee public and nonprofit sectors access to low-cost implants through a negotiated price with FHI. This will result in up to an approximate 70% reduction in cost that can be passed directly to service delivery programs.

Zarin® is offered at a cost of up to 70% lower than existing contraceptive implants.

Through Pharm Access Africa Ltd Zarin will also be offered in a convenient surgical Kit containing a sterile trocar, sterile Scalpel, sterile auto-destruct single use syringe & needle , Sterile Compress & Sterile latex gloves. Thereby ensure access to the contraceptive even at remote and not so well equipped locations.