Analytical Method Transfer for Raw Materials, Intermediates, In-process Tests and Final Compound

At CRAMSN Research Park, SOP-driven analytical method transfers ensure accuracy and compliance, with pre-approved protocols, batch analysis, and defined acceptance criteria guiding the process.

Technology Transfer

Technology transfer shall be conducted based on an optimization study or familiarization report. QA shall hand over all documents along with the technology transfer checklist to the concerned plant QA.

The data generated (document transfer) at the development center will be transferred to the manufacturing facility which would include:

• Raw material list along with specifications and method of analysis

• Optimization report or finalized process for the manufacturing

• Holding study data of reaction mass, wet or dry intermediates

• Recovery or reuse of solvent (as applicable)

• Reprocessing or rework procedures (as applicable)

• Details of analytical methods for in-process controls, intermediates and final compound

• Reference standards

• Process flow diagram

• Equipment justification reports

• Details of process safety evaluation and the recommendations

Based on the technology transfer document batch production record to be generated prior to manufacturing start up

Approval of BPR and Start of Manufacture

After completion of the technology transfer, the required Batch Production Records (BPR) will be generated based on the details provided by the technical team and further will be reviewed and approved by the Quality Assurance (QA) team. Post-completion of the BPR approvals, manufacturing will follow.

We will share the BPR (before it is reviewed and approved by the internal QA team) with the customer team for information purposes only. However, if there are any specific comments from the customer, the BPRs will be further refined as required.

Intermediates and API Contract Manufacturing

CRAMSN Research Park supports clients through late-phase development, regulatory filings, and cost optimization for commercial and post-patent APIs in highly regulated markets like the USA, Europe, and Japan.

• Flexible Manufacturing – From kilos to multi-ton cGMP production of KSMs, RSMs, intermediates, and APIs.

• Global Compliance – Facilities inspected by US FDA, UK MHRA, TGA Australia, PMDA Japan, and more.

• Specialized Technologies – Expertise in peptides, HPAPIs, steroids, and prostaglandins. CRAMSN Research Park ensures seamless scalability, regulatory excellence, and cutting-edge capabilities for your manufacturing needs.

Small Scale Molecule Development

CRAMSN Research Park in Hyderabad, India, comprises over 15 state-of-the-art API manufacturing facilities operated by 7 entities under the MSN Group. Below is a summary of each unit's key features:

This detailed breakdown provides a comprehensive overview of CRAMSN Research Park's API manufacturing capabilities across its various units. Each facility is equipped with a range of equipment and infrastructure to support diverse chemical processes and production scales, while adhering to strict quality management standards.

Analytical Capability at The Plant

Chromatography Equipments

• HPLC instruments coupled with UV, PDA, ELSD, CAD and RI detectors with Empower 3 software

• GC instruments FID, TCD, ECD detectors with Empower 3 software

• UPLC instruments

• Ion Chromatography

Advanced Characterization Techniques

• Waters Absolute LCMS TQXS

• Agilent LC MS with triple quad mass detectors

• Agilent GC MS with triple quad mass detectors

• UV-Visible spectrophotometer

• FT- IR

• Bruker 600 MHz NMR spectroscopy

• ICPMS Agilent 7800

Solid State Characterization Techniques

• DSC,TGA and DVS instruments

• Particle size analyzer: Malvern Master sizer 3000

• Headspace Coulometer, Karl Fischer Analyzer

• XRD Bruker D8 Advanced

• Hot stage Microscopy

• Surface Area Analyzer

• Capillary Zone electrophoresis (CZE)

Preparative Chromatography

• Preparative Scale HPLC (mg - gram Scale)

• Flash Chromatography equipped with ELSD

• Gel Permeation Chromatography

• Ion Exchange Chromatography

• Bench-Top Lyophilizer