Our Broad Business Model

Firmlink’s Vendor Boundary Conditions

Must have a PIC approvable site.
Have niche products not requiring Bioequivalence Studies; Hepatitis C; Oncology Injectables; Speciality Injectables; Opthalmic Drops; Inhalers; Patches; Medical/Diagnostic Devices.
Or if Oral Solids – have differentiated / value-added OSD with BEs.
Piggy-back on existing regulated projects.
Dossier development capability.
Global mindset.
Flexibility of batch size and packaging.

Maximum site approvals (17) arranged by any company thru TFDA, Taiwan.
Pioneer company to arrange for FDA, Philippines; FDA, Taiwan ; BPOM, Indonesia and ANVISA approvals in Bangladesh and India
220 + Product filings done with Phil. FDA of which over 120 approvals at an average of 14.2 months.
124 products signed in with Taiwanese companies – maximum for any generic product organization.
Strong relations at the CXO level with 7 of the top 10 Bangladeshi players.
Signed Sourcing agreements with 75 vendors across geographies.
Leading Brands launched from Firmlink stable in Philippines, Taiwan, Vietnam, Indonesia & Bangladesh.
Licensed Products with partners in Korea , EU , Taiwan, South Africa , Indonesia & Australia.
Supply arrangements with 7 major leading players in Philippines.

Finding ideal, accredited sourcing partners.
Sourcing difficult to formulate / manufacture product : Hep C ; inhalers; patches; onco; medical devices, etc.
Site approvals from TFDA/PFDA/BPOM/ANVISA/ customer audits.
Tripartite agreement signing.
Product dossier vetting and filing.
Product approvals / MA’s.
Negotiations driven to maximize market realizations to make it attractive for all parties.
Ensuring reliability of supplies.
Licensing agreements.