TWi is a specialty pharma with both R&D and production capacity. TWi's headquarters and research center are located in Neihu District, Taipei, Taiwan while the manufacturing facility is located in the Chungli Industrial Park (“Chungli Plant”). TWi secures additional capacity for sterile products by acquiring Synpac-Kingdom Pharmaceutical Co., Ltd. in 2017.

The Chungli plant is located at No.3-1, Ziqiang 4th Rd., Chungli Dist., Taoyuan City 320, Taiwan. This facility currently has three major sections: R&D and pilot production area, production area, and warehouse. Our Chungli plant is responsible for the process development, production scale up, High Barrier Generics production, inventory management and storage and delivery logistics. Our facility is compliant with US cGMP quality standard and has completed the US FDA audit.

Building One

• Currently manufactures many marketed products, including the 250 mg and 500 mg Divalproex Sodium ER Tablets, a controlled release oral tablet manufactured for Par Pharmaceuticals. This product has been manufactured at our Chungli plant and being exported to US since 2009.
• For TWi's future oral products pipeline, roughtly 3~5 drugs will be manufactured at Building One. The production lines for these drugs are currently under construction.

Building Two

• Acquired through merging U-Liang Pharmaceuticals in 2013.
• Current under renovation for expanding our R&D capacity and increasing production lines for TWi's own products for future product launch needs.

Synpac-Kingdom Plant

• Acquired through 97.01% equity investment in Synpac-Kingdom Pharmaceutical Co., Ltd. in November 2017.
• Focused on ophthalmic products, including ointment and drops, with primary business from CMO in Taiwan as of now. The quality system will be further enhanced to be in compliance with US FDA requirements as a strong support TWi's ANDA filings as well as commercial production for the US market.

Audit Record

• 2018.07Building One and Building Two passed cGMP Audit by US FDA.
• 2018.07Neihu office passed referring laboratory Audit by Taiwan Food and Drug Administration.
• 2018.05Building Two passed New dosage (ointment) and GDP Audit by Taiwan Food and Drug Administration.
• 2017.05Building Two passed PIC/S cGMP Audit by Taiwan Food and Drug Administration.
• 2017.01Building One and Neihu office passed PIC/S cGMP & GDP Audit by Taiwan Food and Drug Administration.
• 2016.12Building Two passed PAI Audit by US FDA.
• 2015.08Building Two passed New dosage (gel) Audit by Taiwan Food and Drug Administration.
• 2014.09Building Two passed PIC/S cGMP Audit by Taiwan Food and Drug Administration.
• 2014.05Building One and Building Two passed US FDA cGMP & PAI Audit with zero 483 deficiency.
• 2014.03Building One and Building Two passed PIC/S cGMP Audit by Taiwan Food and Drug Administration.
• 2012.10Building One passed new dosage Audit by Taiwan Food and Drug Administration.
• 2012.09Building One passed US FDA cGMP & PAI Audit with zero 483 deficiency.
• 2011.05Building One passed Completed PIC/S cGMP Audit by Taiwan Food and Drug Administration.
• 2008.12Building One passed cGMP Audit by Taiwan Food and Drug Administration.
• 2007.07Building One passed US FDA PAI Audit with zero 483 deficiency.
• 2006.11Building One passed cGMP Audit by Taiwan Food and Drug Administration.