https://lmspiq.fda.gov.tw/web/DRPIQ/DRPIQ1000Result?licBaseId=143C1CEF-79BF-4296-BD0B-7DB14C5C959F
License Number: DOH-PM-035935
Category: OTC
Dosage Form: Plaster
Manufacturer: Teh Seng Pharmaceutical Mfg. Co., Ltd. Secondary Factory
Address: No. 42-1, Huan Gong Road, Yong Kang District, Tainan City, Taiwan
This product has completed analytical method validation, process validation, and stability testing.
Raw material control
Process control
Finished Product Control
Incoming Materials: Raw material supplier evaluation, raw material inspection
In-process Control: In-process control, process effectiveness verification
Finished Products: Finished product inspection
Post-market Management: Customer complaint system, defective product recall mechanism, regular inspections by regulatory authorities
Establish standard operating procedures (SOPs) for drug safety monitoring programs, risk management, and CAPA System.
This product is manufactured under Teh Seng Pharmaceutical’s proprietary production license and represents an advanced hydrogel-based transdermal patch technology. The formulation is protected under the company chairman’s Republic of China invention patent, titled “Hydrophilic Transdermal Absorption Preparation” (Invention Patent No. I227145). In addition, the product incorporates further technological enhancements developed by Teh Seng’s R&D team, leading to the acquisition of a second Republic of China patent for its improved release liner design, titled “Improved Backing Film for Medicated Patches” (Utility Model No. M253362). These patents reflect the company’s continued commitment to innovation in transdermal delivery systems and the development of high-performance hydrogel patches.
