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API production is a high tech, high stakes business

Producing Active Pharmaceutical Ingredients is a high tech, high stakes business

API production: What is an Active Pharmaceutical Ingredient?

An Active Pharmaceutical Ingredient (API) is by the U.S. Food and Drug Administration defined as the following: Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or function of the body.

 

TAPI, global leader in API production and development

In other words The Active Pharmaceutical Ingredient is the part of the drug that produces its effects. The leading manufacturer of APIs today is TAPI, which Specializes in range of API-related production methods. TAPI’s expertise includes chemical synthesis, fermentation, chromatography and plant extraction and is the industry’s largest producer and developer of API products, with over 400, sold to over 1,000 customers around the globe.

 

API Production Methods

TAPI’s state-of-the-art production sites are located in Italy, Hungary, the Czech Republic, Croatia, Israel, India, China, Mexico, and the United States and its two main methods to manufacture API’s are chemical synthesis and fermentation.

Chemical synthesis. Most API’s are produced by chemical synthesis, from a range of compounds. Chemical synthesis involves highly complex chemistry, equipment and procedures. TAPI was a global pioneer in this technique and is still the number one developer and producer of chemically synthesized API’s.

Fermentation. TAPI has also been a pioneer in the development of fermentation based API’s and its portfolio of biotechnologically manufactured API’s is steadily growing. Basically the fermentation process enables living microorganisms to produce the desired active ingredient.

 

Production of High Potency API

A growing number of pharmaceutical products contain Highly Potent Active Pharmaceutical Ingredients (HP APIs) – molecules that are effective at much smaller dosage levels than traditional APIs. TAPI was a pioneer of HP API production and its long tradition of highly potent product manufacturing dates back to the 1980s. Initially, the focus at its High Potency sites was on steroids and steroidal hormones. Later they added oncolytic drugs, muscle relaxants (anaesthesia) and drugs for pulmonary diseases (e.g., COPD and asthma).  Today TAPI operates four main High Potent sites: two in Italy, one in the Czech Republic, and one in Mexico. In addition to meeting industry needs for injectable and respiratory drugs, TAPI has also introduced lyophilization (freeze-drying) and micronization processes on a commercial scale.

 

Significant investment in Research & Development generates a steady flow of API production

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

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