QUALITY INFORMATION SUMMARY (QIS)

INTRODUCTION
(a) Summary of product information:

Non-proprietary name(s) of the finished Co-Trimoxazole Suspension

pharmaceutical product(s) (FPP)
Proprietary name(s) of the finished Cipretrine
pharmaceutical product(s) (FPP)
International non-proprietary name(s) of the Sulfamethoxazole
active pharmaceutical ingredient(s) (API(s)), And
including form (salt, hydrate, polymorph) Trimethoprim
Applicant name and address Deshalom Pharmaceutical Laboratory Ltd
Km 4, Iloko-Ijesa Road, Ilesa
Osun State,
Nigeria.
Dosage form Suspension
Reference Number(s) NA
Strength(s) Sulfamethoxazole:200mg
Trimethoprim:40mg
Route of administration Oral
Proposed indication(s) Co-Trimoxazole is used as an antibacterial
agent
Primary Contact person responsible for this Title: Head Regulatory affairs
application
First name:
Family name:
Title: Regulatory affairs
First name:
Family name:
Contact person's job title Regulatory Affairs, De-Shalom Pharm. Lab. Ltd
Contact person's postal address
Unit De-Shalom Pharm. Lab. Ltd
Building/PO Box number -
Road/Street Iloko-Ijesa Road
Plant/Zone -
Village/suburb
Town/City Ilesa
District and Mandal Ilesa West
Province/State Osun State
Postal code 23435
Country Nigeria
Contact person's email address deshalompharm@gmail.com
Contact person's phone number 09055425106

(b) Administrative Summary:

 Applicant’s date of preparation or revision of January 2018
the QIS
Internal version and/or date of acceptance (WHO use only)

Related dossiers (e.g. FPP(s) with the same API(s) submitted to the Prequalification Team –
Medicines (PQTm) by the applicant):

Reference Prequalified API, strength, dosage form API manufacturer(including

number (Y/N) (eg. Abacavir (as sulphate) address if same supplier as current
(e.g.HA998) 300 mg tablets) dossier
- Y Sulfamethoxazole:200mg Shouguang Fukang Pharmaceutical
Trimethoprim:40mg Co., ltd: North East of
Dongwaihuan Road, Dongcheng
Industrial Area, Shouguang city,
Shandong province, P.R. of China.

2.3.S DRUG SUBSTANCE (or ACTIVE PHARMACEUTICAL INGREDIENT (API)) (NAME,

MANUFACTURER)

Indicate which option applies for the submission of API information:

Name of APIs: Sulfamethoxazole, Trimethoprim

Name of API manufacturer: Shouguang Fukang Pharmaceutical Co., ltd
□ Confirmation of API Prequalification document
□ Certificate of suitability to the British Pharmacopoeia
√ Active pharmaceutical ingredient master file (APIMF) procedure:
APIMF number assigned by WHO (if known): APIMF22; version number(s) including
amendments (and/or date(s)) of the open part: CIPLA/LEVONORGESTREL BP/Ph .
EUR/AP/0001/2015-05-26; version number(s) including amendments (and/or date(s)) of
the closed part: CIPLA/LEVONORGESTREL BP/Ph. EUR/RP/0001/2015-05-26;
□ Full details in the PD
Document version number/identifier of current module 3.2.S:

2.3.S.2 Manufacture (i) (Sulfamethoxazole (Shouguang))

(ii) (Trimethoprim (Shouguang))
2.3.S.2.1 Manufacturer(s) (i) (Sulfamethoxazole (Shouguang))
(ii) (Trimethoprim (Shouguang))
(a) Name, address and responsibility (e.g. fabrication, packaging, labelling, testing, storage) of each
manufacturer, including contractors and each proposed production site or facility involved in these
activities:
Name and address Responsibility API-PQ number Letter of access
(including block(s)/unit(s)) /APIMF/CEP number provided?
(if applicable)
Shouguang Fukang Manufacturing,
Pharmaceuticals Co Ltd, Testing,
168 Beihai Road, North- Packaging, and
East of Dongwaihuan Release site
Road,, Dongcheng
Industrial Area,
Shouguang City,
Shandong, 262 700,
China (People's Republic
of China)

2.3.S.2.3 Control of Materials (Sulfamethoxazole, Trimethoprim, Shouguang) – for API option 4 only

(a) Name of starting material: Not applicable

(b) Name and manufacturing site address of starting material manufacturer(s): Shouguang Fukang
Pharmaceuticals Co Ltd, 168 Beihai Road, North-East of Dongwaihuan Road,, Dongcheng
Industrial Area, Shouguang City, Shandong, 262 700, China (People's Republic of China)
2.3.S.4 Control of the APIs (Sulfamethoxazole, Trimethoprim, Shouguang)
2.3.S.4.1 Specification (Sulfamethoxazole, Trimethoprim, Shouguang)
(a) API specifications of the FPP manufacturer:

Standard (e.g. Ph.Int., Ph.Eur., BP/Ph.Eur., In-house

BP, USP, in-house)