Benefits of having API registration with 3rd party AR in Bangladesh

A local representative/Local agent/Local indenting firm is mandatory for holding the registration (i.e., API Source validation) in Bangladesh.

Definitions:

End user of APIs = Finished medicine manufacturer in Bangladesh

Indenting firm = Local agent for promoting and getting orders from the end user. Indenting firm/indentor takes commission on sale/export value.

Traders = importers. If any importer/trading firm import APIs from foreign API manufacturers, it’s illegal.

Bangladesh Government (DGDA) allows API import by the “End User” only (who have finished medicine manufacturing License/plants).

We are the source validation registration holder of the following API manufacturers:

• Glochem Industries Pvt. Ltd., Hyderabad, India
• Chemeca Drugs Pvt. Ltd., AP, India
• Liford Pharma LLP, Gujarat, India;
• Hetero Drugs Ltd., Hyderabad, India
• Kudos Chemie, India

1. If we hold the registration of your APIs in DGDA (Directorate General of Drug Administration), then DGDA database shows your API names & manufacturer’s name for preparing the order/Block list by the purchase managers of Bangladeshi formulators.

2. You can appoint multiple local agent/indenting firm for specific/targeted Pharmaceuticals in Bangladesh.

3. Local agent/indenting firms do not handover the Original reg. certificates (i.e., source validation certificate) after business discontinuation.

4. We charge very nominal yearly registration holding fees per APIs. We do not ask for the commission on the PI value.

5. Principal (Manufacturer) can export directly to finished medicine formulators (e.g. Square Pharma, Incepta, BEXIMCO, Popular Pharma etc.)

6. We will hand over the Registration certificate to new local agent anytime if manufacturer wants. Only the current year’s Reg. holding fees should be paid.

7. We will provide you the contact person name & address of purchase department.

8. We will visit the purchase department of Bangladeshi clients along with you, if you visit Bangladesh.

In Bangladesh, commercial importers/traders are not allowed to import active pharmaceutical ingredients (APIs). Only the finished formulators having the Drug Manufacturing License (issued by DGDA) are allowed to import APIs with their industrial IRC. IRC means Import registration certificate. Indenting firms are the commissioning agents for promoting the APIs to the Bangladeshi Pharmaceuticals for finished dosage form production. A local representative/indenting firm/local entity is required to apply the source validation of APIs in Directorate General of Drug Administration (DGDA), Bangladesh. Usually, source validation process takes 30 working days to get the source validation certificate issued by DGDA. Without having the source validation of the API plant & the APIs in the DGDA database, Bangladeshi purchase managers cannot select the API during the Block list preparation. Block list is a format of DGDA to get prior approval of raw materials for import into Bangladesh.

Other related services:

(a) We provide dedicated Business development executive for your product promotion to the Local pharmaceuticals.

(b) You can use our office as your country office located in Dhaka.

(c) Payroll management/HR service for your Bangladesh employee.

(d) We will submit your COA/Sample/Price quotation to the Pharma companies in person.

在孟加拉国通过第三方代理机构进行原料药 (API) 注册的益处

在孟加拉国，持有原料药注册（即原料药来源验证）必须指定当地代表/代理商/代理商。

定义：

原料药最终用户 = 孟加拉国的成品药生产商

代理商 = 负责推广并向最终用户获取订单的当地代理商。代理商/代理商会从销售/出口额中收取佣金。

贸易商 = 进口商。任何进口商/贸易公司从国外原料药生产商进口原料药均属违法行为。

孟加拉国政府（药品和药品管理局）仅允许“最终用户”（拥有成品药生产许可证/工厂）进口原料药。

我们是以下原料药生产商的来源验证注册持有人：

• Glochem Industries Pvt. Ltd.，印度海得拉巴
• Chemeca Drugs Pvt. Ltd.，印度安得拉邦
• Liford Pharma LLP，印度古吉拉特邦- 印度海德拉巴 Hetero Drugs Ltd.
• 印度 Kudos Chemie

1. 如果我们持有贵公司原料药在孟加拉国药品管理局 (DGDA) 的注册，DGDA 数据库将显示贵公司原料药名称及生产商名称，以便孟加拉国制药企业的采购经理准备订单/黑名单。
2. 您可以指定多家孟加拉国本地代理商/采购公司，负责特定/目标药品的采购。
3. 本地代理商/采购公司在业务终止后不会移交原始注册证书（即来源验证证书）。
4. 我们仅收取少量原料药年度注册费。我们不收取产品信息价值的佣金。
5. 委托人（制造商）可直接出口至成品药制剂生产商（例如 Square Pharma、Incepta、BEXIMCO、Popular Pharma 等）。
6. 如制造商需要，我们可随时将注册证书移交给新的当地代理商。只需支付当年的注册持有费。
7. 我们将提供采购部门联系人的姓名和地址。
8. 如果您访问孟加拉国，我们将陪同您拜访孟加拉国客户的采购部门。

在孟加拉国，商业进口商/贸易商不得进口活性药物成分 (API)。只有持有药品生产许可证（由孟加拉国药品管理局 (DGDA) 颁发）的成品药制剂生产商才能凭借其工业进口注册证书 (IRC) 进口 API。IRC 指的是进口注册证书。委托公司是负责向孟加拉国制药企业推广 API 以用于成品制剂生产的委托代理商。当地代表/采购公司/当地实体需向孟加拉国药品管理局 (DGDA) 申请原料药 (API) 来源验证。通常，来源验证流程需要 30 个工作日才能获得 DGDA 颁发的来源验证证书。如果原料药工厂的来源验证失败，且 DGDA 数据库中没有相关原料药信息，孟加拉国的采购经理将无法在编制禁售清单时选择该原料药。禁售清单是 DGDA 用于预先批准进口到孟加拉国的原材料的格式。

其他相关服务：

(a) 我们为您的产品在当地制药企业提供专属的业务拓展主管，负责产品推广。

(b) 您可以利用我们位于达卡的办公室作为您在孟加拉国的办事处。

(c) 为您的孟加拉国员工提供薪资管理/人力资源服务。

(d) 我们将亲自向制药公司递交您的分析证书 (COA)、样品和报价单。