API Pharma Tech
API Pharma Tech is a pharmaceutical company focused on delivering quality therapeutic products, including APIs and FDFs, with a strong emphasis on quality, regulatory compliance, and technological innovation. The company aims to be a trusted partner in the pharmaceutical industry, developing and manufacturing challenging and complex APIs and formulations, and providing comprehensive research, development, manufacturing, and analytical services. With a global presence and a team of scientific experts, API Pharma Tech is committed to meeting the expectations of its business partners and ensuring safety and purity in its products.
Industries
Nr. of Employees
small (1-50)
Products
Active pharmaceutical ingredients (APIs) and finished dosage forms (FDFs)
Selective development, manufacturing and marketing of generic and innovative active pharmaceutical ingredients and finished dosage forms (oral and injectable). Sales subject to patent and regional regulatory constraints.
API Process Development
Contract research service focused on API process development.
Analytical Methods, Physicochemical Characterization, In-Vitro Study Protocols
Comprehensive analytical testing services including analytical methods development, physicochemical characterization, and in-vitro study protocols.
CMO Management, Regulatory compliance management, Small & Large Molecule Formulation, API Development and Manufacturing, FDF Development and Manufacturing
End-to-end contract manufacturing organization management, regulatory compliance, small and large molecule formulation, and API/FDF development and manufacturing for orals and injectables.
Generic/New Drug Product Technology Development and Design Formulation
Core operational capability focusing on generic and new drug product technology development and design formulation.
Active pharmaceutical ingredients (APIs) and finished dosage forms (FDFs)
Selective development, manufacturing and marketing of generic and innovative active pharmaceutical ingredients and finished dosage forms (oral and injectable). Sales subject to patent and regional regulatory constraints.
API Process Development
Contract research service focused on API process development.
Analytical Methods, Physicochemical Characterization, In-Vitro Study Protocols
Comprehensive analytical testing services including analytical methods development, physicochemical characterization, and in-vitro study protocols.
CMO Management, Regulatory compliance management, Small & Large Molecule Formulation, API Development and Manufacturing, FDF Development and Manufacturing
End-to-end contract manufacturing organization management, regulatory compliance, small and large molecule formulation, and API/FDF development and manufacturing for orals and injectables.
Generic/New Drug Product Technology Development and Design Formulation
Core operational capability focusing on generic and new drug product technology development and design formulation.
Services
Contract formulation development services covering pre-formulation, formulation design, physico-chemical characterization and support for clinical and commercial dosage forms (oral and injectable).
Contract API process development services focused on creating scalable, transferable processes with emphasis on speed, quality and cost-efficiency and supporting technology transfer to manufacturing partners.
Analytical services across the drug life cycle including method development and validation, stability testing, E/L studies, elemental impurity analysis and GMP batch release testing.
Contract formulation development services covering pre-formulation, formulation design, physico-chemical characterization and support for clinical and commercial dosage forms (oral and injectable).
Contract API process development services focused on creating scalable, transferable processes with emphasis on speed, quality and cost-efficiency and supporting technology transfer to manufacturing partners.
Analytical services across the drug life cycle including method development and validation, stability testing, E/L studies, elemental impurity analysis and GMP batch release testing.
Expertise Areas
- API process development and scale-up
- Formulation development for oral and injectable dosage forms
- Analytical method development and validation
- Stability testing and stability data management
Key Technologies
- High-performance liquid chromatography (HPLC)
- Inductively coupled plasma mass spectrometry (ICP-MS)
- Gas chromatography with headspace (GC-HS)
- Ion chromatography (IC)