Shanghai Dahua Pharmaceutical Co., Ltd.

QUALITY, HONESTY, AND CUSTOMER-DRIVEN SERVI CE

A high-quality, affordable two-rod
contraceptive implant available with
a CE-marked disposable trocar
Providing continuous contraceptive
protection for up to four years
Sino-implant (II) is registered under
various trade names around the
world, including Zarin, Femplant,
Trust and Simplant.
Sino-implant (II)
LONG-ACTING, HIGHLY
EFFECTIVE, REVERSIBLE
Sino-implant (II) is a long-acting method
currently labeled for four years of use.
Until removal is desired, no action from
the user or routine clinical follow-up is
required after initial insertion. Like other
implants, Sino-implant (II) is one of the
most effective contraceptive methods
available. It has an annual pregnancy rate
of less than 1 percent.
After removal of the rods, there is no delay
in a womans return to fertility. Women
who discontinue use of Sino-implant
(II) can expect pregnancy rates that are
comparable to women who are not using
a contraceptive method.
Sino-implant (II) has the same mechanism
of action and amount of active ingredient
as other two-rod implants currently
available on the market.
AFFORDABLE
CONTRACEPTIVE PROTECTION
Although contraceptive implants are
popular worldwide, their high cost
has been a barrier to access in many
countries. Sino-implant (II) addresses
this problem. This high-quality implant cost
about 50 percent less than
others available.
ADVANTAGES FOR FAMILY
PLANNING PROGRAMS AND USERS
Globally, over 200 million women have
an unmet need for safe and effective
contraception. Access to long-acting
contraceptive methods helps couples
achieve their desired family size and can
help countries improve maternal and
child health.
CONTRACEPTIVE IMPLANTS
Sino-implant (II) is a subdermal contraceptive implant. The implant is a set of two exible,
cylindrical rods made of medical-grade silicone elastomer. Each rod contains 75 mg of
levonorgestrel, the active ingredient, for a total of 150 mg. The implant is inserted just under
the skin of a womens upper arm by a trained health care provider using a disposable trocar
as the insertion instrument.
2 SILICONE
ELASTOMER
RODS
DISPOSABLE
TROCAR
COMPANY PROFILE
Shanghai Dahua Pharmaceutical Co.,
Ltd. known as Dahua is a trusted
global leader in the production of safe,
effective and long-acting contraceptive
implants. Our goal is to promote the
reproductive health of women worldwide.
We are committed to quality, honesty and
customer-driven service.
Established in 1991, Dahua is an
enterprise designated by the National
Population and Family Planning
Commission of China (NPFPC) and the
State Food and Drug Administration
(SFDA) for the production of
contraceptive products.
ONGOING QUALITY ASSURANCE
We are committed to ensuring the safety
and quality of our products. The current
manufacturing facility opened in 2004 and
was designed and built to meet China
Good Manufacturing Practice (GMP)
standards. We are GMP certied by the
SFDA. In addition, we are ISO 9001 and
ISO 13485 certied.
We continually evaluate the quality of
the nal product through lot-release
testing conducted on each lot prior
to distribution. These tests, based on
methods approved by the SFDA for
levonorgestrel silicone elastomer implants,
include tests for the identication,
quantication, and release of the active
ingredient and for product sterility.
In addition, an independent quality
evaluation has been conducted since
2008 by FHI 360, a leading international
development organization based in the
U.S. with over 20 years of experience
with quality testing of public health
products. This assessment has included
independent lot-release testing as well as
an extensive battery of tests on the active
ingredient, nal product, sterilization and
packaging conducted annually. The annual
testing uses standards from the United
States Pharmacopeia (USP), the British
Pharmacopoeia (BP), the International
Organization for Standardization (ISO),
and the ASTM (formerly the American
Society for Testing and Materials). The
ndings showed that Dahua demonstrates
the ability to consistently produce
a contraceptive implant that meets
international quality standards.
CE-MARKED DISPOSABLE TROCAR
Currently, Sino-implant (II) is distributed
with a disposable trocar with a CE
mark, which is a mandatory conformity
mark for medical devices in European
Union Member States. A disposable
trocar eliminates the need to clean the
instrument by autoclaving after each use
and facilitates service delivery in low-
resource settings where electricity is not
always available.
HIGH-QUALITY SERVICE DELIVERY
Essential elements of implant
provision include:
Proper counseling before insertion so
that users know about potential side
effects, how to reliably access removal
services, and that implants do not
protect against HIV or other sexually
transmitted infections
High-quality insertion and
removal services
For more information about service
delivery considerations for implants, see:
http://www.k4health.org/toolkits/implants
Highly effective
Long-acting
Simple insertion
and removal
No daily or monthly action
required from the user
Discreet
Reversible
Limited side effects
Appropriate for women who
wish to space or
limit births
No delay in return to fertility
after discontinuation
compared to women not
using contraception
Low cost
Additional advantages of Sino-
implant (II) include the following:
SHANGHAI DAHUA PHARMACEUTICAL CO., LTD.
For information about ordering
Sino-implant (II), please contact
one of our current distributors:
PHARM ACCESS AFRICA, LTD.
(PAAL)
E-MAIL: info@pharmaccessafrica.com
WEBSITE: www.pharmaccessafrica.com
MARIE STOPES INTERNATIONAL
E-MAIL: orders@mariestopes.org.uk
WEBSITE: www.mariestopes.org
DKT INTERNATIONAL
E-MAIL: dkt@ethionet.et
WEBSITE: www.dktinternational.org
WomanCare Global
E-MAIL: simplant@womancareglobal.org
WEBSITE: www.womancareglobal.org
For additional information about the
technical assistance that FHI 360
provides under a Bill & Melinda Gates
grant, please contact:
FHI 360
E-MAIL: Sino_Implant@fhi360.org
WEBSITE: http://www.fhi360.org/en/
Research/Projects/sinoimplant.htm
REGISTRATIONS AND DISTRIBUTION
Sino-implant (II) is registered in over 20 countries worldwide and is
sold under a variety of trade names including Zarin, Femplant, Trust
and Simplant.
We partner with distributors who work in countries around the world.
Most distributors guarantee access to Sino-implant (II) at a low cost to
public and nonprot sectors.
http://en.dahua-sh.com/
SALES OFFICE ADDRESS:
Room 301, Building 2
Lane 425, Baotong Road
Shanghai, 200071
China
TEL.: +86-21-56637324.
COMPANY ADDRESS:
3503 Changzheng Highway
Chongming County
Shanghai, 202174
China
TEL.: +86-21-59311132.
E-MAIL: dahua_sh@yahoo.com.cn