Product Safety
Overview | Pharmacovigilance
We embed safety into every step of our production processes.
PRODUCT DEVELOPMENT
- Bioequivalence
- Pharmacovigilance -Clinical Trials
In this stage we determine the efficacy and safety profiles of our generics and biosimilars vis-a-vis their original drugs.
We do comprehensive bioequivalence and
trials before arriving on
a decision to develop
the product.
MANUFACTURE
- Stability
- Quality Control & Assurance
Stability testing is a very important part of the manufacturing process.
It tells us how the formulation will
behave under various environmental conditions. As previously mentioned, we have a stringent system of internal quality control and assurance.
POST LAUNCH
- Pharmacovigilance
- Post Marketing Surveillance
Once the drug has been launched, our pharmacovigilance department subjects it to post marketing surveillance.
We comply with the globally recognised International Conference on Harmonization (ICH) guidelines in product development, which are benchmarked to specifications that ensure product quality and safety. Each of the products developed is compared with the innovator products, and clinical efficacy and safety, besides bioequivalence, is established.
