Market Cooperation

 The first Ibuprofen Soft Capsules of the Company was approved for the Abbreviative New Drug Application (ANDA) by FDA on June 21,2016. In addition, over the past three years since the first product with ANDA was approved, the products of the Company including Dutasteride Soft Capsules, Naproxen Sodium Soft Capsules, Benzonatate Soft Capsules and Vitamin D2 Soft Capsules have been approved successively.

In accordance with the relevant policies in China, for the generic drugs of the domestic pharmaceutical manufacturers that have been approved for listing in the European Union, the United States and Japan, their application for drug listing can be conducted according to new registration classification of chemical drugs on the basis of relevant materials on overseas registration and application, and they can be included in the priority review. The approval for listing will be considered to pass the consistency evaluation.

 

 

Products that Have Submitted a Registration Application and Are Included in the Priority Review

S/N

Acceptance No.

Drug Name

Applicant for Registration

Conducted on

Date of Publication

1

CYHS1700595

Ibuprofen Soft Capsules

Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd.

2018-06-21

2018-08-09

2

CYHS1800242

Dutasteride Soft Capsules

Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd.

2018-08-29

2018-11-07

 

1. Provide products that satisfy the consistency evaluation; 

2. Provide generic drugs with first-line high-end brand.

 

 

 

  

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