Contract Research & Manufacturing Services

Pure Innogration = Innovate + Integrate

NLL is a highly integrated niche Pharmaceutical player actively engaged into Specialized pharmaceutical intermediates, Active pharmaceutical ingredients (APIs) & finished dosage formulations

With 11 State of the Art facilities, NLL offers a comprehensive Contract manufacturing facility ranging from development of novel synthetic processes through labscale production to the provision of multi-tonne custom synthesis, including the toll manufacturing of active principle. Across locations, NLL maintains high level of product containment throughout the production cycle strictly in sync with global cGMP guidelines.

NLL offers comprehensive and confidential contract manufacturing services for products from development through to bulk production. Some of the services offered include:

  • Process development and optimization
  • Process scale up and validation
  • Preparation and international submission of Drug Master Files and Certificates of Suitability
  • Multi kilo pilot plant production
  • Bulk production
  • Chiral resolution

NLL draws on over 15 years experience in dealing with Beta-lactams manufacturing & process research. NLL offers collective experience of its drawn over the years in both process research & analytical services as a part of its CRAMS project management team offering.

Chemical and Analytical Development

NLL offers a complete process and analytical development service to the pharmaceutical industry. A comprehensive package is available from early rote selection through bulk production and process validation.

Analytical Services
  • Analytical methods development, quantification & validation
  • Structure elucidation
  • Process impurity isolation & identification
  • Reference standard characterization & quantification
  • Microbiological, QC & release testing
  • Stability Programs
Chemical development
  • Literature review and assessment of synthetic opportunities
  • Lead Synthesis/ Custom Synthesis
  • Development f new and existing synthetic routes for both known and new chemical entities
  • Process optimization and scale up to kilo scale production
  • Extraction --- Semi synthesis---Synthesis
  • Isolation, Purification & Characterization
Analytical development
  • Analytical method development
  • Method validation and technical transfer
  • Impurity profiling/identification/characterization
  • Reference standards
  • Stability testing to ICH guidelines
Manufacturing Services
  • APIs- Key drug intermediates
  • Oral & Sterile APIs
  • Development/ Optimization /Scale- up
  • Kilo-scale/ Pilot scale/ Small- scale manufacturing pre-clinical through commercial
  • Clinical Trials Material (CTM): Multi-product manufacturing for Ph-I,II,III
Engineering consulting

NLL’s most valuable asset is the highly qualified interdisciplinary team, with background in various branches of science & engineering and has the capability to find solutions to problems of various level of complexity and magnitude with support from Research Advisory committee of experts from related fields. NLL’s project management team provides the leadership to plan & integrate cross-functional activity to keep projects on time and on budget with a devotion to quality assurance throughout.

NLL project & Engineering team can help you design of plants & scale up of production processes on turnkey basis. NLL project team can assist you with basic processes and detailed engineering services, project co-ordination & turnkey execution.