Modular Formulation Development

To overcome difficulties with in-house research and development, companies are turning to specialized and experienced finished product development experts for their know-how to support in all drug development phases, including:  Establishing product target profiles  Developing suitable analytical methods and galenical formulations  Scaling up  Validating methods and processes  Conducting stability studies […]

Continue Reading

Formulation Development

Pre-formulation Pre-formulation development ranges from proof of concept to characterization. The pre-formulation process is crucial in order to provide practical insights to establish a clear and efficient formulation development plan that will accelerate the development of the drug product. Proof of Concept A feasibility study is performed for the development of a solid oral dosage […]

Continue Reading

Import and Registration of Bulk Drugs and Finished Formulations in India

As per Drugs & Cosmetics Act 1940 and Drugs & Cosmetic Rules 1945, if any substance falling within the definition of a drug (Section 3b of the Act) is required to be registered before import into the country. Not only the drug, but the manufacturing site also needs to be registered for import. If the […]

Continue Reading

Finished dosage formulations demand driving changes for CMOs

As one of the fastest growing areas in the pharmaceutical industry, the demand for finished dosage formulations is having an impact on several aspects of the Contract Manufacturing Organization (CMO) industries. In order to ensure a piece of the finished dosage formulations (FDF) market share, CMOs have adjusted their service offerings, mainly to broaden their […]

Continue Reading