API source validation service in Bangladesh

Required documents for API source validation in Bangladesh

1. Letter of Authorization (Attested by Bangladesh embassy/Chamber of Commerce)

2. Principal company profile (Attested by Bangladesh embassy/Chamber of Commerce)

3. Principal company manufacturing license (Attested by Bangladesh embassy/Chamber of Commerce)

4. Registered office address of the Manufacturer & the factory address (Attested by Bangladesh embassy/Chamber of Commerce)

5. GMP Certificate issued by the Drug Administration authority of the Manufacturing country. (Attested by Bangladesh embassy/Chamber of Commerce)

6. List of Countries where the API is being exported (Attested by Bangladesh embassy/Chamber of Commerce)

7. Certificate of Analysis (COA) with Specification of the API/RM (Attested by Bangladesh embassy/Chamber of Commerce)

8. Product list of the manufacturer (Attested by Bangladesh embassy/Chamber of Commerce)

9. Form-9 (mentioning the product name) – Signed by the manufacturer

*All documents must be submitted as Original copy.

Please, ship the documents to:

Md. Kamruzzaman

Address: 1/3 Nandipara, Road 12, Khilgaon, 1219, Dhaka, Bangladesh

Phone (1): 01978041545

Phone (2): 01813364189

1. 授权书（经孟加拉国大使馆/商会认证）

2. 公司简介（经孟加拉国大使馆/商会认证）

3. 公司生产许可证（经孟加拉国大使馆/商会认证）

4. 生产商注册办公地址及工厂地址（经孟加拉国大使馆/商会认证）

5. 生产国药品监管机构颁发的GMP证书。（经孟加拉国大使馆/商会认证）

6. 原料药出口国家/地区列表（经孟加拉国大使馆/商会认证）

7. 原料药/原材料分析证书（COA）（经孟加拉国大使馆/商会认证）

8. 生产商产品清单（经孟加拉国大使馆/商会认证）

9. 表格9（注明产品名称）- 由生产商签字

来源验证证书有效期：3年

来源验证审批时间：30-40天