https://lmspiq.fda.gov.tw/web/DRPIQ/DRPIQ1000Result?licBaseId=5E3E7E91-3B68-4FB5-8CB2-4B16915F1CF7
License Number: DOH-PM-040358 G-5484
Category: Prescription Use by Physicians
Dosage Form: Patches
Manufacturer: Teh Seng Pharmaceutical Mfg. Co., Ltd. Third Factory
Address: No. 63, 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.
The product manufacturer is Tehseng Pharmaceutical,It is a high-tech gelled aqueous patch formulation of medicine. This aqueous formulation possesses a Republic of Taiwan patent applied for by Chairman Hsu(I 227145 Hydrophilic transdermal preparation ), and Taiwan patent(M 253362 Improved release film for plaster). Furthermore, this product is the first NSAID patch approved by the National Health Insurance Administration of the Department of Health for reimbursement under the National Health Insurance scheme (National Health Insurance Code A040358345).
