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.