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New Trends Producing APIs and Veterinary Drugs

Jul. 07, 2022

Human and veterinary standards for APIs

China's current "Regulations on Veterinary Drug Administration" stipulates that raw materials and excipients used in the production of veterinary drugs should meet national standards or the quality requirements of the veterinary drugs produced; raw and excipient materials used in the production of veterinary drugs, packaging materials in direct contact with veterinary drugs should meet veterinary standards, drug standards, packaging material standards or other relevant standards and should not adversely affect the quality of veterinary drugs.


New Trends Producing APIs and Veterinary Drugs


According to the above provisions, veterinary drugs used in the production of raw materials should meet the following requirements.

First, has been included in the management of veterinary drugs but not included in the scope of drug management of raw materials, should meet the provisions of national standards for veterinary drugs.

Second is not included in the management of veterinary drugs but has been included in the scope of drug management of raw materials, should be in line with the provisions of national standards for drugs.

Third, does not belong to the above two categories of management of raw materials, should meet the quality requirements of the production of veterinary drugs.

For some of both human drug standards, and veterinary standards for APIs, veterinary drug manufacturers can choose their own. Next, the Ministry will strengthen communication and coordination with the State Drug Administration to understand the policy requirements for registration of APIs, to master the registration and approval of APIs, to encourage and support the community to develop innovative veterinary APIs and improve the production process to promote the healthy development of veterinary API industry. At the same time, in the field of veterinary drug management, further increase the supervision and management of the flow of the use of APIs.


New Trends Producing APIs and Veterinary Drugs

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GMP certification

GMP is the abbreviation of Good Manufacturing Practice for Drugs, which can be directly translated as "Good Manufacturing Practice for Drugs". In the whole process of veterinary drug production, the need to use scientific and reasonable, standardized conditions and methods to ensure the production of good veterinary drugs of the whole set of scientific management system.

Up to now, there are about 2,000 GMP certified veterinary drug manufacturers in China. With the development of the veterinary medicine industry, the requirements of GMP for veterinary medicine have become more specialized, specific and standardized. After the periodic re-inspection and re-inspection process, enterprises have regarded GMP as a conscious behavior. Many veterinary companies are constantly exploring the way forward for their GMP development, introducing new concepts in the implementation of GMP management, combining the actual situation with new developments and running in the direction of paperless and electronic development. In order to ensure that the drug production meets the GMP requirements, reduce the costs of the production process and ensure the healthy development of the enterprise. The division of labor within the enterprise is becoming more and more clear and refined.


New Trends Producing APIs and Veterinary Drugs


Environmental requirements

As we all know, APIs are often accompanied by waste water, waste gas, waste residue and other by-products in the production process. And in recent years, as the country pays more and more attention to environmental protection, it is obvious that the development of API industry has put forward higher environmental protection requirements. For example, in 2018, the "Environmental Protection Tax Law" was officially implemented, further increasing the pressure on API companies, nearly 70% of API manufacturers shut down due to the difficulty of bearing the high environmental investment. And in 2019, the introduction of the "Guidance on Promoting Green Development of API Industry" has accelerated the elimination of backward production capacity and promoted the major consolidation of the industry.

In this context, we believe that the future of environmental protection, green process API will be the national industry focus on encouraging the development direction. And by this influence, the industry is expected to API pharmaceutical equipment industry may also usher in more development opportunities. In particular, low-cost, high-efficiency, energy-saving and environmentally friendly pharmaceutical equipment, or will guide the new trend of API production.


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