The API industry is one of the core directions of new pharmaceutical manufacturing in China, with the dual growth of upgrading itself and undertaking the transfer of the global industrial chain, and the logical clarity
of iterative development to a higher-end innovative drug CDMO (customized R&D and production).
At present, affected by the above advantages, the API industry is ushering in rapid development, and a large number of enterprises in the industrial chain are also accelerating their layout
in this field.
In this context, good news such as the listing of products of related enterprises and the acquisition of overseas certificates has also been coming
.
A few days ago, Minova announced that the company's wholly-owned subsidiary Xuancheng Minova Pharmaceutical Co.
, Ltd.
(hereinafter referred to as "Xuancheng Minova") rosuvastatin calcium API passed the technical review of the Drug Evaluation Center of the National Medical Products Administration (hereinafter referred to as "CDE"), and the registration number was changed to "A" status
on the CDE API and pharmaceutical excipients and pharmaceutical packaging materials registration information publicity platform.
It is reported that the product is mainly suitable for primary hypercholesterolemia (LLA type, including heterozygous familial hypercholesterolemia) or mixed dyslipidemia (LLB type)
that cannot properly control dyslipidemia after diet control and other non-drug treatments (such as: exercise therapy, weight loss).
Baiyunshan announced that recently Guangzhou Baiyunshan Pharmaceutical Group Co.
, Ltd.
, a subsidiary of the company, Baiyunshan Chemical Pharmaceutical Factory (hereinafter referred to as "Baiyunshan Chemical Pharmaceutical Factory") received the approval notice of the marketing application for dapoxetine hydrochloride chemical API approved and issued by the National Medical Products Administration (notification number: 2022YS00461).
According to the data, dapoxetine hydrochloride is a short-acting selective serotonin reuptake inhibitor (SSRIs) used in patients over 18 years old to treat premature ejaculation, which was approved for marketing
in China in 2010.
On November 28, Tonghe Pharmaceutical, a leading enterprise of high-end characteristic APIs, announced that the company recently received the gabapentin drug registration certificate (expiration review) issued by the Medicines Control Department of India (DCGI).
Tonghe Pharmaceutical's product Gabapentin API obtained the Indian Drug Registration Certificate, marking that its Gabapentin API continues to obtain access to the Indian market
.
Gabapentin is a derivative of γ-aminobutyric acid (GABA) and is clinically used in the treatment
of neuralgia after herpes infection, as well as epilepsy.
On November 24, Lukang Pharmaceutical announced that the API doxofylline received the "Notice of Approval of the Marketing Application for Chemical APIs"
issued by the State Food and Drug Administration.
This product is a derivative of a new generation of methylxanthines and is mainly used to treat bronchial asthma, wheezing bronchitis, and dyspnea caused by other bronchospasm
.
.
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.
.
.
.
On the whole, the enthusiasm of domestic enterprises to lay out the API track is very high, and it has achieved continuous
results.
It is worth mentioning that out of optimism about the long-term development of the track, many API companies have expressed full confidence
in the fourth quarter and annual performance growth.
For example, in its investor relations activity record released on November 10, Xianju Pharmaceutical mentioned that "looking forward to the fourth quarter and full year, the company is confident of maintaining solid growth
.
" It is understood that in the first three quarters of 2022, it has achieved operating income of 3.
453 billion yuan, a year-on-year increase of 4.
09%; The net profit attributable to shareholders of the listed company was 529 million yuan, a year-on-year increase of 15.
24
%.
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