FORMULATION : CONTRACT RESEARCH & MANUFACTURING

Concord is providing formulation development and contract manufacturing services.

The state-of-the-art formulation facility is certified by DSIR (Department of Science & Industrial Research) INDIA and is having research team comprising of senior scientists. who have experience in developing safe, effective and efficacious complex drug products meeting global regulatory requirements.

The Formulation Development facility comprises of two divisions:

  • Formulation Development Laboratory
  • Analytical Development Laboratory

Some of the major activities undertaken are:

Pre-formulation Development

Objective is to generate information useful in developing bioavailable dosage forms. The study includes information on parameters like physiochemical property of the drug (like drug solubility, partition coefficient, dissolution rate, stability, solid state analysis like polymorphs, particle size), establishment of kinetic rate profile, excipient compatibility studies etc.

Formulation Development

R&D houses capabilities and resources to formulate a wide range of sterile and non-sterile dosage forms including Solid Orals (Tablets & Capsules), Oral Liquids, Oral Suspensions, Lyophilized formulations and Sterile Injectables. Concord is currently working on several Contract Research & Manufacturing projects with global pharmaceutical companies.

Analytical Development

Formulation Development Laboratory is supported by Analytical Development Laboratory, which carries out the following activities as per GLP requirements:

  • Pre-formulation studies like solubility, forced degradation, excipient compatibility.
  • Analytical method development, validation and transfer.
  • Bio-relevant dissolution for formulation selection.
  • Discriminatory dissolution method development based on solubility, pKa, ionization state, and excipients.

The laboratory is equipped with sophisticated equipment like HPLC, GC, GC-HS, Dissolution apparatus, FTIR etc.