What is High Potency expertise?
A growing number of pharmaceutical products contain highly potent active pharmaceutical ingredients (HP APIs) – molecules that are proven to be effective at much smaller dosage levels than traditional APIs, usually at mg scale and below. The HP APIs are classified based on their toxicity, pharmacological potency and occupational exposure limits (OELs). These APIs are frequently characterized by complex structures requiring multi-step processes or semi-synthesis, often involving more than 10 steps.
High-containment manufacturing requires specialized approaches in facility design, equipment selection and manufacturing processes to achieve desired levels of containment, minimize operator exposure, and ensure worker protection and safety.
High Potency Manufacturing
At Teva api, our long tradition of highly potent product manufacturing dates back to the 1980s. Initially, the focus at our HP sites was on steroids and steroidal hormones; subsequently, we added oncolytic drugs, muscle relaxants (anesthesia) and drugs for pulmonary diseases (e.g., COPD and asthma). Placing patient health as a top priority, Teva api prevents any risk of cross contamination with chemical entities active at the µg (microgram) level by operating four dedicated production lines based on our four areas of focus.
Today Teva api operates several HP sites. In addition to fulfilling industry needs for injectable and respiratory drugs, Teva api also has implemented lyophilization (freeze-drying) and micronization processes at commercial scale.
Teva api division products, which involve the use of synthetic organic chemistry expertise, are varied and include API products such as: Tobramycin, Betamethasone valerate, Diflorasone diacetate and more.