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:
Scarcity and supply chain inefficiency in the market
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