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Why changes in the API manufacturing landscape is great news for TAPI

Why changes in the API manufacturing landscape is great news for TAPI

The market for contract API manufacturing set to rise by 5.4% over the next 6 years.

The development and manufacture of new and generic Active Pharmaceutical Ingredients (API) is becoming more complex, specialized and requiring expensive new technologies, procedures and highly skilled staff. This changing landscape is forcing Big Pharma to go through something of a revolution and its business model is changing, much to the benefit of outside API producers like TAPI. Recently more and more pharmaceutical companies have been closing their own API production facilities, and instead are buying their API’s from specialist manufacturers such as TAPI, the worlds leading API manufacturer.

 

New opportunities bring new difficulties

With so many corporations opting to send API manufacturing overseas, primarily to Asia and India there has been significant changes to how these drugs are regulated, with more rigorous guidelines and inspections being put into place. The quality of an API has a huge effect on its safety and usability, with poorly manufactured API’s resulting in serious harm and even death. Therefore it is essential that API’s are manufactured as purely and consistently as possible, stored correctly, comply to all regulatory demands and are counterfeit proof.

 

While outsourcing the manufacture of APIs to third party producers in Asia has helped the drug companies’ bottom line, there are concerns about the quality of these APIs. Which is why the regulatory bodies such as the U.S. FDA, have instigated intense screening and incredibly high demands for documentation throughout the production process. Violations of standards can result in expensive product recalls and heavy fines for the pharmaceutical companies involved.

 

Trust TAPI, the worlds' leading expert and manufacturer of API’s

For more than 80 years quality has been at the heart of TAPI’s global operations, ensuring that its customers consistently receive best-in-class products and services. TAPI’s commitment to quality is uncompromising and can be demonstrated by:

  • Complying with current Good Manufacturing Practice (GMP) standards

 

  • Conducting regular internal and external audits of our manufacturing sites

 

  • Undergoing regular inspections by the FDA, other health authorities and TAPI customers. These inspections keep us at high GMP compliance standards at all times.

 

  • Implementing continual quality improvement initiatives according to emerging industry trends.

 

  • Enforcing rigorous end-to-end control. We ensure our suppliers comply with quality regulations and standards through periodic audits of their facilities.

 

TAPI’s unrivalled standards mean you get the product you can trust time and time again

TAPI is the leading global manufacturer of API’s and Research & Development is one of the key reasons for its dominance in such a competitive market. More than 700 top scientists in TAPI’s seven development centres worldwide are currently working on new, safer and the most consistent manufacturing processes in the industry. They specialize in chemical synthesis, fermentationhigh potencyplant extractionsynthetic peptides, vitamin D derivatives, prostaglandins, and analytical and solid-state R&D.

 

TAPI operate state-of-the-art, high-capacity fermentation plants with total fermenter capacity of 1,870 m3. Operated by skilled and experienced professionals, these fully automated production plants implement complex fermentation and bioconversion projects including subsequent recovery processes. Our proven fermentation production capabilities cover a broad range of technologies and products.

Our significant investment in Research & Development generates a steady flow of API compounds, enabling customers to go to market with new pharmaceutical products more quickly. About half of TAPI’s R&D is dedicated to improving process efficiency and automation, to help customers reduce costs and remain competitive in the global marketplace, safely and in full compliance with all the regulatory demands in your region.

 

Your consistent and trustworthy API manufacturer

If you are interested in working in close co-operation with our profession and friendly team to produce your new or existing API’s, would like to know more about TAPI’s manufacturing capabilities, expertise or facilities, please contact us - We would be delighted to answer your questions, queries or enquiries.