TAIWAN BIOTECH CO., LTD.
信東生技股份有限公司
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1962Founded
NT$3.2BPaid-in capital
3Plants
85Certifications
≥ NT$5BRevenue band
- Unified Business No.
- 43211700
- Industry
- Pharmaceuticals & Medicinal Chemicals (273)
- Main products
- Pharmaceuticals & medicinal chemicals (276)
- Location
- No. 22, Jieshou Rd., Fenglin Vil., Taoyuan Dist., Taoyuan City 330042, Taiwan (R.O.C.)
Taoyuan City (10,976) · Taoyuan Dist. (907) - Listing
- Public company (unlisted) (298) 1770
- Registration status
- Approved / Active
- Organisation type
- Company Limited by Shares
- Founded
- 1962-10-09
- Paid-in capital
- NT$ 3,200,000,000
- Representative
- Ko Chang-chi
- Phone
- 03-3612131
- Website
- https://www.sintong.com/
- Exporter
- Yes — registered with the Trade Administration
- Annual revenue band
- ≥ NT$5B
- Ownership
- Group subsidiary / corporate-held · Yu Yuan Co., Ltd.、Taiwan Chuang Yeh Tou Tzu Co., Ltd.、Yung Yu Industrial Co., Ltd.、Hsing Cheng Yuan Kuo Chia Fa Chan Chi Chin Kuan Li Huei、Ching Shen Tang Tou Tzu Co., Ltd.
- North American market
- FDA medical device registration FDA drug establishment registration
- Representative tenure
- In office since at least 2013 (13+ years)
- Growth & profitability
- Revenue 2026-09 YoY -4.7%, year-to-date -3.0%
Gross margin 35.6%, operating margin 8.4%, net margin 11.7% (2026-Q2 YTD) - Compliance record
- FDA import refusal: 2 product(s), latest 2024-09-10
Environmental penalties: 5 case(s) in 5 years, latest 2025-07-01, fines NT$ 326,000 (toxic chemicals; water pollution; industrial waste)
Plants 3
- Plant · No. 22, Jieshou Rd., Taoyuan Dist., Taoyuan City In production
- Yuanliaoyao Plant · No. 22-1, Jieshou Rd., Taoyuan Dist., Taoyuan City In production
- Guanyin Plant · No. 1, Guojian 1st Rd., Guanyin Dist., Taoyuan City In production
Certifications 85
- Medical device license (188)Official registry Valid until 2012-06-07 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (188)Official registry Valid until 2012-06-07 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (188)Official registry Valid until 2010-12-05 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (188)Official registry Valid until 2009-01-11 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (188)Official registry Valid until 2007-10-23 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (188)Official registry Valid until 2003-06-18 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (188)Official registry Valid until 2004-02-09 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (188)Official registry Valid until 2004-02-09 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (188)Official registry Valid until 2004-02-09 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (188)Official registry Valid until 2004-02-09 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (188)Official registry Valid until 2004-02-09 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (188)Official registry Valid until 2004-02-09 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (188)Official registry Valid until 1995-02-22 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (188)Official registry Valid until 1996-05-22 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (188)Official registry Valid until 1996-07-03 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (188)Official registry Valid until 2000-01-04 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (188)Official registry Valid until 1997-02-28 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (188)Official registry Valid until 1997-04-14 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (188)Official registry Valid until 1997-04-28 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (188)Official registry Valid until 1992-05-07 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (188)Official registry Valid until 1995-02-15 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (188)Official registry Valid until 1995-02-22 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (188)Official registry Valid until 2000-07-25 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (188)Official registry Valid until 2000-04-12 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (188)Official registry Valid until 1995-01-04 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (188)Official registry Valid until 1995-01-04 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (188)Official registry Valid until 1995-01-10 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2016-07-14 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2027-02-14 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2029-07-19 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2017-06-07 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2022-05-18 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2022-02-28 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2020-02-07 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2022-02-28 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2031-08-14 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2022-04-03 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2018-08-05 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2028-08-05 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2029-02-09 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2020-02-15 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2020-02-22 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2028-08-05 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2027-04-03 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2020-01-10 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2020-01-04 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2027-05-18 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2022-05-18 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2020-02-15 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2020-02-22 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2027-04-03 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2020-04-13 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2020-09-28 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2017-05-18 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2018-03-28 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2020-02-07 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2029-05-21 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2029-05-20 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2018-08-05 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2018-07-13 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2029-02-09 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2030-04-13 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2017-06-07 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2019-02-09 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2029-02-09 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2028-08-05 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2017-05-18 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2018-02-01 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2021-07-03 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2021-05-22 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2022-02-28 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2020-02-07 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2020-02-07 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2020-04-12 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2020-04-12 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2020-04-12 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2020-04-24 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2020-10-16 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2018-07-03 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2011-02-09 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2020-04-13 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2032-01-20 · Taiwan Food and Drug Administration (TFDA)
- GMP (261)Self-reported
- ISO 13485 (310)Self-reported
- PIC/S GMP (46)Self-reported
Processes & materials 1
- Biotechnology (664) · Company nameSelf-reported
North American market evidence 3
- FDA medical device registration 9617489 2007-11-21 – 2016-11-28
Accessories, Soft Lens Products; Products, Contact Lens Care, Rigid Gas Permeable - FDA drug establishment registration 3003598505 12/31/2026
MANUFACTURE - FDA import refusal 3003598505 2024-09-10
ATROPINE SULFATE (ANTI-CHOLINERGIC); EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
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