Analytical R&D capabilities at Natco:

The Analytical R & D (ARD) caters to API, Formulations development for generics as well as NCEs. The ARD has ability to support small molecules, peptides and non-biological complex drugs. We also have in house capability to support a wide variety of formulations development for cytotoxic and high potency molecules in parenteral (embracing nano; liposomal & micro particulate technologies) and solid dosage forms.

A wide range of chromatographic separation techniques (HPLC, UPLC, GC, and IC) and detection techniques (UV, FL, MS, ELSD, RI, FID, TCD, etc.) to meet the requirement of different types of compounds including the ones that do not have chromophores.

Structural Chemistry and Solid State Characterisation:

Method Development:

At the API and Formulation R&D divisions, we develop process and product specific analytical methods, which are suitable for the intended use of application. We develop various analytical methods to comply with global quality and regulatory standards.

Analytical method development for Immediate Release, Extended release, Controlled substances, for various Cytotoxic and Non Cytotoxic formulations like Tablets, Capsules (hard and soft gelatin), Powder for suspensions, Dry powder Inhalers, Injections (Liquid and Lyophilised Products), Complex Injections (like Liposomes) …. Etc.

Method Validation:

Analytical method validations are executed in alignment with stringent SOP, which is based on ICH Q2 guidelines and in adherence to cGMP & GLP requirements.

Method Transfer:

We ensure successful method transfer to the manufacturing sites with: