Research & Development

Research & Development

Through adoption of latest technologies and use of modern best practices in the field of product development Tabros Pharma launching latest generic medicines.

At Tabros Pharma fully dedicated, cGMP compliant and qualified facility is available for all developmental research work. Separate facilities are used for warehousing, manufacturing, packaging and testing.

Dedicated, qualified and cGMP compliant equipments are available for formulation of all dosage forms. A separate laboratory equipped with modern analytical equipments is available for testing of all kind of developmental work. Technical staff in product development section is highly competent and trained on modern principles of quality by design as well as on conventional best practices.

Starting materials are procured from GMP qualified sources approved by US-FDA, MHRA UK, TGA Australia, PMDA Japan or any other international stringent regulatory authority belonging to Europe etc. A valid GMP certification is a pre-requisite for vendor qualification together with detailed review of all technical documentation, evaluation of vendor quality management system, full characterization of materials and impurities before approval and finally customer audit if required. Technology transfer studies are implemented for new molecules.

At Tabros Pharma drug products are designed and developed in the light of published scientific literature and after fully characterization of innovator brands. Pre-formulation studies and API compatibility studies are practiced. To achieve quality target product profile and required standards of Quality, Safety, Efficacy and Purity, a risk based approach is adopted for design, development and validation of product formulations and analytical procedures following modern scientific thinking and principles of quality risk management described in ICH guidelines. Design of experiments is used to evaluate design space of critical quality attributes of drug products as required by ICH guidelines.

Stability studies are performed using validated stability indicating assay methods and evaluation of stability data is performed according to criteria described in ICH guidelines.

At Tabros Pharma we ensure that generic versions are therapeutically equivalent to international innovator brands therefore in Vitro and in Vivo bioequivalence studies are performed if required as per current international requirements to prove that our generic versions are bioequivalent with innovator products.

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