RESEARCH AND DEVELOPMENT (PROCESS R&D FACILITY)

We, have a state of art Formulation & Development facility, designed for developing innovative research techniques and unique therapeutic approaches for developing finished dosage forms in vials.

Formulation development center is well-equipped for the development of sterile powder dosage forms in vials.

Our Research & Development Facility is well-equipped for development of various Sterile API along with capability to handle through Crystalline and Lyophilization technique.

We have a specialized team which spearheads our research in for the development of market-specific Sterile API. Our R & D scientists possess substantial experience and expertise in the area of product development and transfer of technology of developed products of Beta Lactam and Cephalosporin

KEY STRENGTHS

Robust analytical method is a major milestone in quality product development and for faster regulatory approval. Team of analytical experts designs analytical methods which are best suitable for intended use of application. The team has expertise in developing stability indicating analytical methods using Quality by Design approach and as per current regulatory requirements. We believe in developing methods those are right at the first time'.

ANALYTICAL R&D

FORCED DEGRADATION STUDY

Forced degradation studies integral part of analytical method, in order to establish stability indicating behavior of methods and product characteristics.

METHOD VALIDATION

Method validations are carried out as per ICH and latest regulatory norms and in accordance to GLP requirements. Good documentation practices are followed throughout the process.

METHOD TRANSFER

Analytical methods are transferred to receiving unit through a protocol bound study in accordance with regulatory requirements.

STABILITY STUDIES:

To enhance the quality of product at R&D scale Stability studies are conducted as per ICH norms.

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