Conventional Products

 

TTY is highly experienced in developing conventional products and particularly specializes in various oral dosage forms (including immediate-release and sustained-release drugs), liquid injection forms, ointments, and gels. We have a wide portfolio of products that have been successful in the global market.

 

Formulation Development

TTY's R&D team puts effort not only into launching products onto the market but also into advancing pharmaceutical formulation of original drugs. Some of our formulations include:

  • Amtrel®: TTY modified the capsule form of the brand-name drug into tablets, which are scored so that they can be split in half. This modification makes it convenient for doctors to easily adjust the dosage for clinical applications. Amtrel® is patented and highly esteemed by customers.
  • Gemmis®: TTY modified the lyophilized dose form of the brand-name drug into an injectable solution. The injectable solution is safer for patients than the lyophilized form of the drug.
  • Tyxan®: The first generic Docetaxel injection approved in the EU.
  • Oxalip®: TTY modified the lyophilized dose form of the brand name drug into an injectable solution that helps prevent precipitate forming in the solution, which is safer for patients.

 

Well-Equipped Analytical Development Laboratories

TTY is well-equipped with analytical instruments. These include, but are not limited to:

  • Dissolution equipment for in vitro release testing, including dissolution apparatus I, II, IV for screening oral dosage forms
  • Instruments for particle size determination, ranging from nanometers to micrometers
  • Chromatography facilities for chemical identification and separation, including reverse phase HPLC, normal phase HPLC, UPLC, HPLC-ELSD, LC/MS, LC/MS/MS, GC, IC, HPTLC
  • Other equipment such as DSC, Karl Fischer titrator, Hardness tester, Friability tester are used in characterization testing

 

Our Pilot Plant Focuses on Process Development

Take your formulation from laboratory scale into commercial production using our pilot plant. Our pilot plant is equipped with instrumentation specific for formulating oral, injectable, or ointment dosages.

  • Oral dosages

Glatt GPCG1 fluid bed granulator (Spray, Wrust, Far centrifugal), Supermixer (1Kg, 3Kg, 10Kg), Oscillator, V-blender, Compressor, Film coater

  • Injectable dosages

Compounding tanks, Sterility filtration, Aseptic filling, Lyophilizer, Homogenizer, Microfluidizer, Extruder, dialysis system

  • Ointment dosages

Vacuum emulsifying machine

 

Animal Studies

Use mice, rats, or other animal models for rapid formulation screening. For a full list of the types of animal studies we can perform, please contact us directly.

 

Commercial Production

TTY has three factories in Taiwan with different manufacturing capabilities.

  • Chungli factory: A dedicated factory for production of oncology drugs which is inspected by TFDA (Taiwan), PDMA (Japan), EMA and US FDA. This factory has several production lines for oncology medications, which allows for the manufacturing of oral tablets, oral capsules, liquid injections, liposomes, and lyophilized products.
  • Lioudu factory: A dedicated factory for production of non-oncology drugs such as oral tablets, oral granules, oral capsules, liquid injection, liposomes, microsphere long-acting injections and lyophilized products.
  • Neihu factory: The Neihu factory focuses on clinical trial production and is inspected by TFDA (Taiwan) and EMA. Furthermore, it is equipped with facilities for parenteral injections and excipient production line.

 

CMC Submission

TTY combines an extensive understanding of the regulatory approval process with an exemplary regulatory history to fully support our pharmaceutical development programs.

TTY has much experience in the preparation of Common Technical Document (CTD).