FTF Pharma Private Limited — contract research and development, formulation development, regulatory strategy and bioequivalence studies at Sanand, Ahmedabad, Gujarat.
FTF Pharma Private Limited is a Contract Research Organization (CRO) and Contract Development & Manufacturing Organization (CDMO) focused on pharmaceutical and generic-drug development. Incorporated on 20 June 2012, FTF Pharma positions itself as an R&D-driven pharmaceutical company providing consultation, innovation and development solutions for pharmaceutical and generic-drug companies.
FTF Pharma Private Limited, Block No. 193 (Part) + 211 (Part), Xcelon Industrial Park, Chak-de-India Weigh Bridge Road, Vasana Chacharwadi, Taluka Sanand, Ahmedabad, Gujarat – 382213, India.
Contract research · contract development · formulation development · dossier development · regulatory strategy · bioequivalence/clinical strategy · product identification · licensing of dossiers · technology transfer · troubleshooting · IP/non-infringement strategy.
Tablets, capsules, scale-up, pilot BE batches, generic formulations.
Development and formulation services for liquid dosage forms.
Liquid formulations, lyophilized products, sterile-product development.
Formulation-development services for topical dosage forms.
Galenical/laboratory-scale formulation development · oral formulation development · topical formulation development · injectable formulation development · NCE formulation development · bioavailability enhancement · formulation upgrading · new dosage forms · new combinations · QbD implementation.
Global regulatory landscape assessment · ANDA strategy · ANDS strategy · Marketing Authorization applications · DCP / CP / MRP pathways · 505(b)(2) strategy · pre-NDA preparation · DMF/COS evaluation · mock regulatory audits · CMC strategy · BE/clinical- trial related regulatory support.
Bioequivalence strategy · clinical-trial strategy · protocol design · CRO coordination · IVIVC · IVIVR · BCS waiver strategy.
Forward integration of API companies · backward integration of finished-dosage-form companies · infrastructure development · QbD implementation · formulation development · NCE formulation · bioavailability enhancement · formulation upgrades · technology transfer · new dosage forms · new combinations · 505(b)(2)/ new-drug applications.
FTF Pharma invests more than US$1 million annually in R&D, developing approximately 3–5 new generic molecules and 3–4 innovative formulation projects per year, using formulation-development and galenical laboratory infrastructure (~3,000 sq. ft.) and analytical facilities including HPLC and GC.
Global IP landscape evaluation · non-infringement assessment · API/product IP assessment · patent strategy · product selection based on patent opportunities · dossier/product strategy. FTF Pharma has also been identified in Indian patent publications as an applicant for pharmaceutical formulation inventions.
New-product identification · market/product evaluation · product selection · dossier development · licensing opportunities · product development for regulated markets.
FTF Pharma has established markets/activities across the European region, USA, Canada, New Zealand, Australia, China and South Africa.
Published achievements include 60 products out-licensed for EU and US markets, 12 differentiated generic products filed in the EU through DCP, 30 generic products in development, first 505(b)(2) products developed/planned for filing, and 21 patents filed nationally or through PCT over the stated five-year period.
