Azunate (Artesunate Powder of Injection) Powder for solution for injection 60

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Artesunate

Available from:

Macleods Pharmaceuticals Limited, INDIA

ATC code:

Antimalarials

INN (International Name):

Artesunate

Dosage:

60

Pharmaceutical form:

Powder for solution for injection

Manufactured by:

Macleods Pharmaceuticals Limited, INDIA

Product summary:

Physical description: White powder; Local technical representative: RK Pharmaceuticals (TZ) LIMITED (2050)

Authorization status:

Registered/Compliant

Authorization date:

2021-03-29

Summary of Product characteristics

TMDA/DMC/MRE/F/016
Version#1
TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY
PUBLIC ASSESSMENT REPORT FOR AZUNATE (ARTESUNATE 60 MG) POWDER FOR
INJECTION.
VERSION NUMBER 0.1,
MARCH 2022
P. O. Box 77150, EPI Mabibo, Off Mandela Road, Dar es Salaam, Tanzania
Tel: [phone]; Fax: [phone]
Email: [e-mail]; Website: mwww.tmda.go.tz
1.
INTRODUCTION
Azunate
is
an
artemsinin
derivative
medicine
belonging
to
P01BE03
-
Artemisinin
and
derivatives, plain group. Azunate exerts is activity by causing
cleavage of endoperoxide bridge
in the pharmacophore of DHA and therefore generates reactive oxygen
species (ROS), which
increases oxidative stress and causes malarial protein damage via
alkylation. In addition,
Artesunate potently inhibits the essential Plasmodium falciparum
exported protein 1 (EXP1), a
membrane glutathione S-transferase. As a result, the amount of
glutathione in the parasite is
reduced. Azunate is approved in Tanzania for use in adults and
children.
1.1 PRODUCT DETAILS
Registration number
TAN 21 HM 0132
Brand name
Azunate
Generic name, strength and form
Artesunate Powder for Injection of 60 mg
ATC classification
P01BE03 - Artemisinin and derivatives, plain
Distribution category
POM
Country of origin
India
Associated product
Not Applicable
Marketing Authorization Holder
Macleods Pharmaceuticals Limited.
304, Atlanta Arcade, Marol Church road,
Andheri (East),
INDIA.
Local Technical Representative
RK Pharmaceuticals (Tz)Limited
Plot No 326,
Dar es Salaam
1.2 ASSESSMENT PROCEDURE
The application for registration of Azunate was submitted on
06/09/2019, the product underwent
full
assessment.
Assessment
was
completed
in
two
rounds
of
evaluation.
Azunate
was
registered on 29/03/2021.
1.3 INFORMATION FOR USERS
Visual description of the finished product
White powder in a clear 10 mL USP type-III glass
vial sealed with 20 mm grey bromo butyl rubber
plugs
and
20
mm
chocolate
brown
flip
off
aluminum seal.
Primary packing material
10 mL USP Type-III glass vial with 20 mm Grey
Bromo-butyl