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On April 9, Renfu Pharmaceutical announced that its holding subsidiary Yichang Renfu Pharmaceutical received the FDA approval number for ibuprofen tablets, which means that the product can be produced and sold in the US market
.
Renfu Pharma has achieved fruitful results in the export of preparations overseas, and has won more than 90 ANDA numbers so far
.
Table 1: The latest approved products of Renfu Pharma Fever due to cold or influenza
.
It is reported that Yichang Renfu will submit an ANDA application for ibuprofen tablets in 2021, with a cumulative R&D investment of approximately US$1.
4 million
.
The company said that the ibuprofen tablets obtained the FDA approval number this time marks that Yichang Renfu has the qualification to sell the product in the US market, which will have a positive impact on the company's expansion of the US generic drug market, and the company will actively promote the follow-up.
Preparations for the launch of the product in the US market
.
Yichang Renfu's ibuprofen tablets are also sold in the domestic market.
The company carried out a consistency evaluation study in 2017, and a bioequivalence study in 2019.
It was declared in August 2019 and approved for review in September 2020
.
The product successfully won the bid for the fourth batch of national procurement, and then the sales increased rapidly.
According to the data of Minet.
com, in the first half of 2021, it will be sold in the terminals of Chinese urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as Chinese public medical institutions).
In the corporate structure of ibuprofen tablets, Yichang Renfu Pharmaceutical has become a TOP4 company with a market share of 6.
05%
.
Table 2: The ANDA numbers obtained by Renfu Medicine Source: The data from the global marketed drug database of Minet shows that Renfu Medicine has obtained more than 90 ANDA numbers, involving 75 products (active ingredients + dosage forms).
On the track of exporting preparations overseas, Renfu Medicine has always been in a leading position
.
Source: company announcement, Minet database Note: ANDA data statistics are as of April 6, if there are any omissions, please correct me!
.
Renfu Pharma has achieved fruitful results in the export of preparations overseas, and has won more than 90 ANDA numbers so far
.
Table 1: The latest approved products of Renfu Pharma Fever due to cold or influenza
.
It is reported that Yichang Renfu will submit an ANDA application for ibuprofen tablets in 2021, with a cumulative R&D investment of approximately US$1.
4 million
.
The company said that the ibuprofen tablets obtained the FDA approval number this time marks that Yichang Renfu has the qualification to sell the product in the US market, which will have a positive impact on the company's expansion of the US generic drug market, and the company will actively promote the follow-up.
Preparations for the launch of the product in the US market
.
Yichang Renfu's ibuprofen tablets are also sold in the domestic market.
The company carried out a consistency evaluation study in 2017, and a bioequivalence study in 2019.
It was declared in August 2019 and approved for review in September 2020
.
The product successfully won the bid for the fourth batch of national procurement, and then the sales increased rapidly.
According to the data of Minet.
com, in the first half of 2021, it will be sold in the terminals of Chinese urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as Chinese public medical institutions).
In the corporate structure of ibuprofen tablets, Yichang Renfu Pharmaceutical has become a TOP4 company with a market share of 6.
05%
.
Table 2: The ANDA numbers obtained by Renfu Medicine Source: The data from the global marketed drug database of Minet shows that Renfu Medicine has obtained more than 90 ANDA numbers, involving 75 products (active ingredients + dosage forms).
On the track of exporting preparations overseas, Renfu Medicine has always been in a leading position
.
Source: company announcement, Minet database Note: ANDA data statistics are as of April 6, if there are any omissions, please correct me!
