FORM -5

[SEC RULE 26(L)]

APPLICATION FORM FOR REGISTRATION OF A DRUG FOR
LOCAL MANUFACTURER

I / We Rizwan Umer Sheikh, CEO of Winthrox Laboratories hereby apply for

registration of the drug, namely ARTINEO Sachet (Dihydroartemisinin 15mg
+Piperaquine Phosphate 120 mg) details of which are enclosed.

Date: ___________

Place: Karachi Signed: …………………………………..

ENCLOSURE OF THE APPLICATION FOR REGISTRATION OF THE DRUG FOR
LOCAL MANUFACTURER:

Dosage Form; Sachet

1. Name and Address of the manufacturer: : Winthrox Laboratories (Pvt.) Ltd

K-219, S.I.T.E, Superhighway phase II, Karachi

2. Brand (Proprietary) name of Drug: : ARTINEO SACHET

3. The chemical name(s) and, as Dihydroartemisinin 15mg ,

appropriate and available the established Piperaquine phosphate
(generic) names and synonyms of the drug.

4. Strength of active ingredient(s) per : Each Sachet Contains

unit, e.g. each tablet or 5ml etc. contains. Dihydro …..….5mg

5. Pharmacological group. Antihistaminic and antiallergic

6. Recommended Clinical Use. : Annexure I, enclosed
7. Proposed use of administration : Oral
8. Proposed dosage. : Annexure I, enclosed

9. Proposed shelf life of the drug. : 03 Years

10. Proposed storage condition of : Store in a dry place below 30ºC and protect from
finished product. sunlight. Keep away from children

11. Unit Price of the drug, e.g. per

tablet, per capsule, per 5ml, etc.

12. In case of International availability, Annexure I

provide the following information,
namely:-

(a) Name of the drug; Clrainex

(b) Country where sold/registered; and USA
(c) Name of company selling the drug or MERCK SHARP DOHM
having registration to manufacture
(include supporting documents/proof of
international registration).

Production Manager Quality Control Manager

13. Brand name(s) of drug available 1) Larinex
in Pakistan. 2) Alenor

14. Name(s) of company(s) 1) Getz Pharmaceuticals (Pvt) Ltd

manufacturing in Pakistan. 2) Macter International (Pvt) Ltd

15. Composition (actives & : Annexure II, enclosed

excipients) including statement of the
quantitative composition, giving the
weight or measure for each actives
substance used in the manufacturing of
the dosage form and the claims to be
made for drugs.

16. Outline of method of : Annexure III, enclosed

manufacture.
17. Person whose direct supervision
and
control the drug is manufactured with the : Annexure IV, enclosed
following details, namely:- : Annexure IV, enclosed
(a) Total number of technical staff; and
(b) Name, qualification and
designation of the persons directly
supervising the manufacture of the
drugs applied for registration, and
any change shall be properly
documented and record maintained :Annexure V, enclosed
by the manufacturer.
18. Name of equipments that will
be used in the manufacture of the drug
applied for registration:
GMP compliant

1. ____________________ Yes No

2. ____________________ Yes No

3. ____________________ Yes No

4. ____________________ Yes No

Quality Control Manager

Production Manager : Annexure VI, enclosed
19. Full description of the
specifications and analytical method
necessary to assure the identity,
strength, quality, purity and
homogeneity through out the shelf life : Annexure VII, enclosed
of the drug product.

20. Name, qualification and

designation of the persons who will be : Annexure VIII, enclosed
responsible for the quality control of
the drug.

21. Description of the equipment to

be used for the quality control of the : Annexure IX, enclosed
active raw material and the finished
products.

22. Labeling and prescribing

information (to be mentioned on the Not applicable
pack/leaflet) specimen or draft shall be Not applicable
submitted for the following class as of Not applicable
drugs, namely:-
(a) C.N.S. stimulates; Not applicable
(b) Drug affecting uterine motility;
(c) Drugs inhibiting hormonal
production Not applicable
(d) Hormones and other steroidal
preparation excluding preparation
for external and topical use; Not applicable
(e) Narcotics drugs as per single
convention on Narcotics Drugs
1961; and
(f) Psychotropic substances mentioned
as per convention on psychotropic
substances, 1971 :Annexure X, enclosed
(Specimen of label to be submitted
as soon as production starts)
: Annexure XI, enclosed
23. Facility of water processing
with specifications.
: Annexure XII, enclosed
24. Environment control processing
with details.

25. Type of container/packaging.

Quality Control Manager

Production Manager : Annexure XIII, enclosed

26. A copy of last Inspection Report

conducted by the Ministry of Health

________________ ____________________
Production Manager Quality Control Manager
 UNDERTAKING

I / We hereby undertake that the above giving information is true and correct to the best of
my / our knowledge and belief.

________________ ____________________
Production Manager Quality Control Manager

Chief Executive Officer