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On April 1, Huahai Pharmaceutical announced that the ANDA of levetiracetam injection and febuxostat tablets declared by the company to the FDA had been approved.
As of the announcement date, Huahai Pharmaceutical had invested in the research and development of the above two products.
The costs are about 5.
98 million yuan and 14.
3 million yuan respectively
.
According to data from Minet.
com, Huahai Pharmaceutical has obtained 5 ANDAs approved by the FDA since the beginning of this year
.
As of the announcement date, Huahai Pharmaceutical had invested in the research and development of the above two products.
The costs are about 5.
98 million yuan and 14.
3 million yuan respectively
.
According to data from Minet.
com, Huahai Pharmaceutical has obtained 5 ANDAs approved by the FDA since the beginning of this year
.
Levetiracetam injection is an anti-epileptic drug developed by UCB.
It was first listed in the United States in 2006.
In 2021, UCB's levetiracetam has global sales of 970 million euros (as of April 1st).
exchange rate, about $1.
07 billion)
.
Currently in the United States, the main manufacturers of levetiracetam injection include Viatris, Aurobindo, Hikma,
etc.
It was first listed in the United States in 2006.
In 2021, UCB's levetiracetam has global sales of 970 million euros (as of April 1st).
exchange rate, about $1.
07 billion)
.
Currently in the United States, the main manufacturers of levetiracetam injection include Viatris, Aurobindo, Hikma,
etc.
In the domestic market, Huahai Pharmaceutical submitted an application for the marketing of levetiracetam concentrated solution for injection in November 2020 as a generic category 4 solution.
It has recently entered the stage of administrative approval and is expected to be approved in the near future
.
It has recently entered the stage of administrative approval and is expected to be approved in the near future
.
Febuxostat is a xanthine oxidase inhibitor developed by Tekeda, which is mainly used for the long-term treatment of hyperuricemia in gout patients
.
The original product was first launched in the United States in March 2009.
Currently, in the United States, the main manufacturers of febuxostat tablets include Viatris, Sun, and Alembic
.
.
The original product was first launched in the United States in March 2009.
Currently, in the United States, the main manufacturers of febuxostat tablets include Viatris, Sun, and Alembic
.
Huahai Pharmaceutical's febuxostat tablet ANDA was tentatively approved by the FDA in May 2018, and this is the official approval
.
In the domestic market, Huahai Pharmaceutical once submitted a listing application for febuxostat tablets in 2014, and then voluntarily withdrew it.
It is still in the BE trial stage
.
.
In the domestic market, Huahai Pharmaceutical once submitted a listing application for febuxostat tablets in 2014, and then voluntarily withdrew it.
It is still in the BE trial stage
.
Huahai Pharmaceutical stated that the approval of the ANDA number of levetiracetam injection and the official approval of febuxostat tablets indicate that the company is qualified to sell the above-mentioned products in the US market, which is conducive to the company's continuous expansion of the US market.
Sales, strengthen the product supply chain, enrich the product echelon, enhance the market competitiveness of the company's products, and have a positive impact on the company's operating performance
.
Sales, strengthen the product supply chain, enrich the product echelon, enhance the market competitiveness of the company's products, and have a positive impact on the company's operating performance
.
ANDA approved by Huahai Pharmaceutical from 2022 to present
Source: Minet Global Listed Drug Library
According to data from Minet.
com, including levetiracetam and febuxostat, Huahai Pharmaceutical has obtained 5 ANDA approvals from the FDA since the beginning of this year, of which empagliflozin linagliptin is tentatively approved
.
com, including levetiracetam and febuxostat, Huahai Pharmaceutical has obtained 5 ANDA approvals from the FDA since the beginning of this year, of which empagliflozin linagliptin is tentatively approved
.
Source: Mi Intranet database, announcements of listed companies, etc.
Note: The statistics are as of April 1st, if there are any omissions, please correct me!
On April 1, Huahai Pharmaceutical announced that the ANDA of levetiracetam injection and febuxostat tablets declared by the company to the FDA had been approved.
As of the announcement date, Huahai Pharmaceutical had invested in the research and development of the above two products.
The costs are about 5.
98 million yuan and 14.
3 million yuan respectively
.
According to data from Minet.
com, Huahai Pharmaceutical has obtained 5 ANDAs approved by the FDA since the beginning of this year
.
As of the announcement date, Huahai Pharmaceutical had invested in the research and development of the above two products.
The costs are about 5.
98 million yuan and 14.
3 million yuan respectively
.
According to data from Minet.
com, Huahai Pharmaceutical has obtained 5 ANDAs approved by the FDA since the beginning of this year
.
Levetiracetam injection is an anti-epileptic drug developed by UCB.
It was first listed in the United States in 2006.
In 2021, UCB's levetiracetam has global sales of 970 million euros (as of April 1st).
exchange rate, about $1.
07 billion)
.
Currently in the United States, the main manufacturers of levetiracetam injection include Viatris, Aurobindo, Hikma,
etc.
It was first listed in the United States in 2006.
In 2021, UCB's levetiracetam has global sales of 970 million euros (as of April 1st).
exchange rate, about $1.
07 billion)
.
Currently in the United States, the main manufacturers of levetiracetam injection include Viatris, Aurobindo, Hikma,
etc.
In the domestic market, Huahai Pharmaceutical submitted an application for the marketing of levetiracetam concentrated solution for injection in November 2020 as a generic category 4 solution.
It has recently entered the stage of administrative approval and is expected to be approved in the near future
.
It has recently entered the stage of administrative approval and is expected to be approved in the near future
.
Febuxostat is a xanthine oxidase inhibitor developed by Tekeda, which is mainly used for the long-term treatment of hyperuricemia in gout patients
.
The original product was first launched in the United States in March 2009.
Currently, in the United States, the main manufacturers of febuxostat tablets include Viatris, Sun, and Alembic
.
.
The original product was first launched in the United States in March 2009.
Currently, in the United States, the main manufacturers of febuxostat tablets include Viatris, Sun, and Alembic
.
Huahai Pharmaceutical's febuxostat tablet ANDA was tentatively approved by the FDA in May 2018, and this is the official approval
.
In the domestic market, Huahai Pharmaceutical once submitted a listing application for febuxostat tablets in 2014, and then voluntarily withdrew it.
It is still in the BE trial stage
.
.
In the domestic market, Huahai Pharmaceutical once submitted a listing application for febuxostat tablets in 2014, and then voluntarily withdrew it.
It is still in the BE trial stage
.
Huahai Pharmaceutical stated that the approval of the ANDA number of levetiracetam injection and the official approval of febuxostat tablets indicate that the company is qualified to sell the above-mentioned products in the US market, which is conducive to the company's continuous expansion of the US market.
Sales, strengthen the product supply chain, enrich the product echelon, enhance the market competitiveness of the company's products, and have a positive impact on the company's operating performance
.
Sales, strengthen the product supply chain, enrich the product echelon, enhance the market competitiveness of the company's products, and have a positive impact on the company's operating performance
.
ANDA approved by Huahai Pharmaceutical from 2022 to present
Source: Minet Global Listed Drug Library
According to data from Minet.
com, including levetiracetam and febuxostat, Huahai Pharmaceutical has obtained 5 ANDA approvals from the FDA since the beginning of this year, of which empagliflozin linagliptin is tentatively approved
.
com, including levetiracetam and febuxostat, Huahai Pharmaceutical has obtained 5 ANDA approvals from the FDA since the beginning of this year, of which empagliflozin linagliptin is tentatively approved
.
Source: Mi Intranet database, announcements of listed companies, etc.
Note: The statistics are as of April 1st, if there are any omissions, please correct me!
On April 1, Huahai Pharmaceutical announced that the ANDA of levetiracetam injection and febuxostat tablets declared by the company to the FDA had been approved.
As of the announcement date, Huahai Pharmaceutical had invested in the research and development of the above two products.
The costs are about 5.
98 million yuan and 14.
3 million yuan respectively
.
According to data from Minet.
com, Huahai Pharmaceutical has obtained 5 ANDAs approved by the FDA since the beginning of this year
.
As of the announcement date, Huahai Pharmaceutical had invested in the research and development of the above two products.
The costs are about 5.
98 million yuan and 14.
3 million yuan respectively
.
According to data from Minet.
com, Huahai Pharmaceutical has obtained 5 ANDAs approved by the FDA since the beginning of this year
.
Levetiracetam injection is an anti-epileptic drug developed by UCB.
It was first listed in the United States in 2006.
In 2021, UCB's levetiracetam has global sales of 970 million euros (as of April 1st).
exchange rate, about $1.
07 billion)
.
Currently in the United States, the main manufacturers of levetiracetam injection include Viatris, Aurobindo, Hikma,
etc.
It was first listed in the United States in 2006.
In 2021, UCB's levetiracetam has global sales of 970 million euros (as of April 1st).
exchange rate, about $1.
07 billion)
.
Currently in the United States, the main manufacturers of levetiracetam injection include Viatris, Aurobindo, Hikma,
etc.
In the domestic market, Huahai Pharmaceutical submitted an application for the marketing of levetiracetam concentrated solution for injection in November 2020 as a generic category 4 solution.
It has recently entered the stage of administrative approval and is expected to be approved in the near future
.
It has recently entered the stage of administrative approval and is expected to be approved in the near future
.
Febuxostat is a xanthine oxidase inhibitor developed by Tekeda, which is mainly used for the long-term treatment of hyperuricemia in gout patients
.
The original product was first launched in the United States in March 2009.
Currently, in the United States, the main manufacturers of febuxostat tablets include Viatris, Sun, and Alembic
.
.
The original product was first launched in the United States in March 2009.
Currently, in the United States, the main manufacturers of febuxostat tablets include Viatris, Sun, and Alembic
.
Huahai Pharmaceutical's febuxostat tablet ANDA was tentatively approved by the FDA in May 2018, and this is the official approval
.
In the domestic market, Huahai Pharmaceutical once submitted a listing application for febuxostat tablets in 2014, and then voluntarily withdrew it.
It is still in the BE trial stage
.
.
In the domestic market, Huahai Pharmaceutical once submitted a listing application for febuxostat tablets in 2014, and then voluntarily withdrew it.
It is still in the BE trial stage
.
Huahai Pharmaceutical stated that the approval of the ANDA number of levetiracetam injection and the official approval of febuxostat tablets indicate that the company is qualified to sell the above-mentioned products in the US market, which is conducive to the company's continuous expansion of the US market.
Sales, strengthen the product supply chain, enrich the product echelon, enhance the market competitiveness of the company's products, and have a positive impact on the company's operating performance
.
Sales, strengthen the product supply chain, enrich the product echelon, enhance the market competitiveness of the company's products, and have a positive impact on the company's operating performance
.
ANDA approved by Huahai Pharmaceutical from 2022 to present
Source: Minet Global Listed Drug Library
According to data from Minet.
com, including levetiracetam and febuxostat, Huahai Pharmaceutical has obtained 5 ANDA approvals from the FDA since the beginning of this year, of which empagliflozin linagliptin is tentatively approved
.
com, including levetiracetam and febuxostat, Huahai Pharmaceutical has obtained 5 ANDA approvals from the FDA since the beginning of this year, of which empagliflozin linagliptin is tentatively approved
.
Source: Mi Intranet database, announcements of listed companies, etc.
Note: The statistics are as of April 1st, if there are any omissions, please correct me!
