Table Of Contents (TOC) for KINGDOM OF CAMBODIA

Application form (see annexure I)

Certificate of a Pharmaceutical product (see annexure II)

GMP certificate

3-1 Free-sale certificate

3-2. Domestic-sale invoice 

3-3. Performance certificates

3-4. Certificate of responsible for quality of the products

4.  Summary of the product characteristic (see annexure III)

5.  Unit formula with indicated reference and function of each ingredient

6.  Batch formula

7.  Manufacturing process and in-process control

8.  Testing method of each ingredient

9.  Certificate of analysis of the active ingredient

10. Specification of the finished product

11.Testing method of the finished product

12. Certificate of analysis of the finished product

13. Stability study, 3 batches at 30 +/-2oC, 70+/-5%RH and testing method

14. Pharmaco-Toxicological Document (Not required for Generic product)  Clinical Document (Not required for Generic Product)

 Requirement for Samples.  Annexure I

MINISTRY OF HEALTH                                                      KINGDOM OF CAMBODIA

DIRECTORATE GENERAL FOR HEALTH                     NATION - RELIGION - KING

DEPARTMENT OF DRUGS AND FOOD

8, Ung Pokun Street, Phnom Penh, Cambodia

Phone: (855-23) 880247-48

Fax: (855-23) 880247                                                                                  

APPLICATION FORM FOR MARKETING AUTHORIZATION

A- DETAIL OF APPLICANT AND MANUFACTURER:

1- Applicant's:

     Name: Hetero Drugs Limited.

    Address: “Hetero House”, H.No.8-3-166/7/1, Erragadda, Hyderabad-500 018, India.

    Phone: 040-23704923/24/25.

    Fax: 040-23704926.

2- Manufacturer’s*:

     Name: Hetero Drugs Limited.

     Address: 22-110, IDA, Jeedimetla, Hyderabad-500 055, India.

     Phone: 040-23096171/72/73/74.

     Fax: 040-23095105.

Manufacturer responsible for final batch release. Other manufacturers: