API Development & Manufacturing Solutions

  • Tailored solutions offered with speed and accuracy
  • Portfolio identification to ensure updated pipeline of strategic products
  • End-to end API development from IP evaluation to technology transfer
  • Strong IP back up to ensure non-infringing process for APIs
  • Dedicated team to handle lab development, chemical synthesis and technology transfer process
  • Laboratory equipped to handle complex chemical reactions (Hecks reaction, Chiral separations, Swern oxidations, Suzuki coupling etc) right from method developments to validations
  • Active participation in filing strategy and global regulatory framework

Drug Product Solutions

  • API portfolio identification by and large compliments our finished dosage pipeline
  • Key criteria for the selection of API pipeline:
  1. Scarcity and supply chain inefficiency in the market
  2. API development and synthesis is highly expensive
  • High preference by Clients to obtain exclusive dossier rights of FDF and API Excessive reach and connectivity across the globe with the CMOs for FDF and API having compliances by FDA, EU GMP, MHRA, TGI and Health Canada
  • Dedicated team handles technology transfer and regulatory filings for DMFs and ANDAs