RAW MATERIALS:
To best cater the complexities of the pharma production procedures and to have a stable formulation, our efficient Technical Sales Team helps our clients in choosing the correct source of raw materials, having the desired technical specifications.

Our Strength:

• Technology Development Centre in India with focus on new APIs with non-infringing process development.
• Technology transfer from Lab to Plant.
• Highly qualified team for Process and Analytical Development,Experienced Regulatory and IPR Team.
• Emphasis on QMS complying to ICH Q7A – GMP guidelines, 21 CFR Part 210-211 and WHO GMP.

Over the years we have partnered with some of the best names in the International Pharma Industry to provide our customers with consistent and customized:-
1. ACTIVE PHARMACEUTICAL INGREDIENTS - APIs
2. PELLETS
3. EXCIPIENTS

Services:

Our Capabilities for services in API & Formulation Business:-

• Cost Effective Process Development & Manufacturing – APIs & Intermediates.
• Documentation for Technology Transfer (TT)
• Quality Assurance System establishment in organization & providing services for QA along with Regulatory Filings (DMFs / ANDA)
• Contract Research Projects



CRAMS Product Development in case of APIs and Formulations are done in the below sequence of operations:-

• Selection of molecule (information from client) followed by Literature Survey.
• Selection of ROS followed by Technical and then Commercial Proposal.
• Preparation of Protocol and approval from client.
• Development of the product as per timelines meeting technical specifications.
• Analytical method development and analysis.
• Compatibility Studies to be done (in case of formulations)
• Stability Program Management & Analytical Method Validation.
• Product Development Report (TT) and Product Transfer.