Tenglyn Tablet, Film-coated

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Teneligliptin

Available from:

Cadila Healthcare Limited, INDIA

ATC code:

DPP-4 Inhibitor

INN (International Name):

Teneligliptin

Dosage:

20

Pharmaceutical form:

Tablet, Film-coated

Manufactured by:

Cadila Healthcare Limited, INDIA

Product summary:

Physical description: Light pink coloured, round shaped, biconvex, film coated tablets, plain on both sides; Local technical representative: Abacus Pharma Africa Limited (8473)

Authorization status:

Registered/Compliant

Authorization date:

2021-06-03

Summary of Product characteristics

TMDA/DMC/MRE/F/016
Version#1
TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY
PUBLIC
ASSESSMENT
REPORT
FOR
TENGLYN
20
MG
(TENELIGLIPTIN
HEMIPENTAHYDROBROMIDE HYDRATE EQUIVALENT TO TENELIGLIPTIN 20 MG)
FILM COATED TABLETS
VERSION NUMBER 1.0
15 APRIL, 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
Tenglyn 20mg is a generic medicine of Tenelia 20mg Tablets
manufactured by Mitsubishi Tanabe
Pharma Corporation & Daiichi Sankyo, Japan. The proposed product is a
tablet that contains, as
the active ingredient, teneligliptin hemipentahydrobromide hydrate
(hereinafter referred to as
teneligliptin), a dipeptidyl peptidase (DPP)-4 inhibitor. DPP-4
inhibitors are therapeutic drugs for
type 2 diabetes that increase the concentration of active
glucagon-like peptide-1 (GLP-1) in the
blood, thus promoting glucose-dependent insulin secretion, and
inhibiting glucagon secretion,
resulting in antihyperglycemic effects. Tenglyn 20mg is approved in
Tanzania for use in adult
patients.
1.1 PRODUCT DETAILS
Registration number
TAN 21 HM 0210
Brand name
Tenglyn 20mg
Generic name, strength, and form
Each film coated tablet contains: Teneligliptin Hemipenta
Hydrobromide Hydrate equivalent to Teneligliptin 20 mg
ATC classification
Dipeptidyl peptidase 4 (DPP4) inhibitors (Antidiabetic)
ATC code: A10BH
Distribution category
POM
Country of origin
India
Associated product
N/A
Marketing Authorization Holder
Cadila Healthcare Limited,
Zydus Tower, Satellite Cross Roads, Ahmedabad 380
015, India
Email: [e-mail]
Local Technical Representative
Abacus Pharma (A) Ltd,
18C, Warehouse No. 4, Nyerere Road, P.O. Box 12294,
Dar es salaam, Tanzania
Email: [e-mail]
1.2 ASSESSMENT PROCEDURE
The application for registration of Tenglyn 20mg was submitted on 26
June 2018. The product
underwent full assessment. Assessment was completed in 2 (two) rounds
of evaluation and the
prod