Capabilities

Capabilities

Formulation Development

  • Formulation Development for NCE Products
  • Novel formulations for improved delivery of existing dosage forms 505(b)(2) 
  • We offer comprehensive solutions for preformulation including Sub-micron and Nano size reduction products to enhance the Bioavailability
  • Conventional release, Controlled release and sustained release formulations
  • O/W, W/O emulsion and Colloidal drug delivery system
  • Process Development & Optimization and trouble shooting of existing formulation
  • We have DEA approval to develop CII to CV Product

Analytical Service

  • Method Development for API, raw Materials, In-Process and Finished Products using sophisticated equipments by our FDA experienced, well trained analytical chemists.
  • We provide exceptional support for validation and seamless transfer of analytical methods.
  • All our equipments and methods are aligned with US FDA requirements

Stability Testing
We provide stability testing ( Accelerated and RT stability condition) for the RLD and finished dosage forms 

Technology Transfer
Dharma labs will evaluate the Process optimization  studies based on the CMOs equipment capacity and their  available excipients  before initiating  seamless technology transfer of the product formulation and its analytical methods to pilot or commercial scale manufacturing to customer defined manufacturing site.

Regulatory Affairs
We do and also help our customers for any regulatory affairs and  eCTD for the API -DMF and also for the ANDA and NDA filling 

Project Management
Our project management is responsible for managing the development project from inception to completion, ensuring  regular customer communication on timelines, technical details and development process.

Services

Product Development We have extensive Product development expertise in Branded and generic product with  decades of drug pre-formulati

Read more...