BACK

Formulation

SERVICE AREAS & COMPETENCES

Service Areas

Pre-formulation and discovery support

  • Solubility, stability, compatibility, logP testing
  • Solid form screening and selection
  • Physicochemical profiling, drug ability assessment

Formulation and process development

  • Formulation screening using stability, dissolution and animal PK
  • Process development based on physicochemical and physical properties of drug candidates
  • Storage and shipping conditions assessment of drug candidates
  • Technology transfer of formulation and manufacturing process to clinical manufacturing sites
  • CMC document preparation for IND/NDA/ANDA submission

Generic formulation and product development

  • Patent analyses and bypassing strategies
  • Reverse engineering of branded drugs
  • Innovative formulation and process development
  • Key platform technologies:
    • Conventional dosage forms
    • Modified release dosage forms
    • Poorly soluble drug formulations

Filing document preparation

  • CMC document preparation and regulatory support
  • CFDA/FDA/EMA/TFDA dossier filling support
  • CTD format IND/NDA/ANDA filing support

EQUIPMENT

Rotary tablet press (8 stations, 19 stations)

Bilayer rotary tablet press (14 stations, B/D turret)

High shear vertical granulators (1L ~ 25L)

Fluid bed granulator, dryer and coater (1L ~ 10L)

Extruder and spheronizor

Spray dryer, with solvent recovery unit

Lyophilizer, 0.4 m2 with auto capping

Roller compactor

Quadro Comil

Perforated pan coater (1.5L ~ 8L)

Automatic capsule filler (for solids, liquids and semi-solids) and capsule sealer

Powder X-Ray diffraction (Powder XRD)

Differential Scanning Calorimetry (DSC)

Thermal Gravimetric Analysis (TGA)

Dynamic moisture vapor sorption (DVS)

Polarized microscopy

Dissolution stations with online UV detector, auto-sampler

Ultrasonic Homogenizer

High shear dispersing emulsifier

Moisture analyzer

High speed freezing centrifuge

Proven Track Record

Product Type Generic (CFDA) Generic (Foreign) NME
lmmediate Release 3 2 4 (3 CFDA CTP approved)
Modified Release 6 4 1 (US phase III trial)
lnjectables 2 0 4 (3 CFDA CTP approved)
Topical 2 0 0