the first ibuprofen soft capsules of the company was approved for the abbreviative new drug application (anda) by fda on june 21,
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. |
|
|
2 |
cyhs1800242 |
dutasteride soft capsules |
humanwell puracap pharmaceuticals (wuhan) co., ltd. |
|
|
1. provide products that satisfy the consistency evaluation;
2. provide generic drugs with first-line high-end brand.