Supplier management policy
To ensure focused management and risk control, and in compliance with the Company’s “Supplier Management Procedures,” TSH Biopharm classifies suppliers into three major categories based on their attributes:
■Finished product suppliers: Partners that provide pharmaceutical products that have completed manufacturing and packaging.
■Contract manufacturers: Manufacturers commissioned by the Company to carry out pharmaceutical production or contract manufacturing.
■Active pharmaceutical ingredient (API) suppliers: Sources that provide the active ingredients of drugs.
TSH manages suppliers through qualification review, on-site audits, improvement guidance, and a follow-up mechanism, while promoting environmental friendliness and paying attention to sustainability issues, to build a sustainable supply chain.
The management policy covers four major aspects:
Quality management｜The Company evaluates suppliers’ quality systems and supply quality through questionnaires filled out by contracted manufacturers, on-site audits, and data reviews. We require suppliers to provide official inspection reports from the past three years, validPIC/S GMP documents, Taiwan FDA Drug Master File (DMF) registrations for active pharmaceutical ingredients, Certificates of Analysis from original manufacturers, and Material Safety Data Sheets (MSDS).
■Delivery time｜The Company selects credible and reliable suppliers to ensure timely delivery and reduce lead times. It establishes secondary material sources and finished product safety stock levels for inventory management to maintain supply stability.
■Service｜Vendors provide prompt quotations, complete documentation, deliver quality products meeting specifications, and demonstrate high cooperation. Willingness to promptly visit the facility to understand and resolve quality issues if problems arise.
■Sustainability and Human Rights | Encourage suppliers to obtain certifications such as ISO 14001, ISO 45001, and AED safe premises. The evaluation standards also cover basic human rights clauses such as the prohibition of child labor and the elimination of forced labor, and require the signing of a corporate social responsibility self-assessment questionnaire.
Supplier Evaluation Mechanism
To ensure supply chain stability and compliance with internal control and sustainability requirements, the Company has established a comprehensive mechanism—from “new supplier onboarding and screening” to “existing supplier classification and dual-track evaluation system”—in accordance with the “Supplier Management Procedures:”
1.New Supplier Screening
For new partners seeking inclusion in the Company’s qualified supplier list, we implement a strict qualification review and ESG screening to ensure they not only meet quality standards but also demonstrate environmental and social responsibility awareness.
■Qualification review: Suppliers are required to provide documents such as pharmaceutical manufacturer/distributor licenses, valid PIC/S GMP certificates, factory registration certificates, and the latest version of the Site Master File (SMF). ESG and quality evaluation: Evaluators conduct on-site inspections or perform documentary reviews through the “entrusted manufacturer questionnaire (including sustainability questionnaire).”
■The review aspects cover: quality system: manufacturing, quality assurance, warehousing, and validation systems. Sustainability indicators: Environmental management (such as ISO 14001), labor human rights, and occupational health and safety (such as ISO 45001).
2025 Screening Performance
In 2025, 1 new supplier (outsourced warehousing) was added, and 100% passed screening and on-site audits covering environmental, social, and quality standards, with evaluation results complying with GDP regulations.
2. Existing Supplier Classification and Dual-Track Evaluation System
To effectively manage risks, the Company implements a dual-track management mechanism of “annual comprehensive evaluation” and “periodic re-evaluation” for suppliers already included in the qualified supplier list, applying tiered management based on evaluation results.
Supply Chain ESG Engagement Practices and Effectiveness
Beyond quality and operating performance, the Company extends its management reach to environmental and social aspects through the “Supplier Corporate Social Responsibility Self-Assessment Questionnaire” and on-site visits. In 2025, the Company deepened its collaboration with key suppliers, with the following specific results:
1.New Supplier Screening
In 2025, 1 new supplier (outsourced warehousing) was added, and 100% passed screening and on-site audits covering environmental, social, and quality standards, with evaluation results complying with GDP regulations.
2.Periodic Re-Evaluation
In 2025, a total of 5 sites were audited this year (including 4 manufacturing plants and 1 warehouse), with audit results showing 100% compliance with GMP/GDP regulations.
3.Key Supplier ESG Performance (Engagement)
We encourage suppliers to respond to the CSR questionnaire (which will be renamed the ESG questionnaire after 2026) and obtain international certifications. The following are the specific ESG initiatives of key partners in 2025:
2025 Key Supplier ESG Performance Highlights
To ensure focused management and risk control, and in compliance with the Company’s “Supplier Management Procedures,” TSH Biopharm classifies suppliers into three major categories based on their attributes:
■Finished product suppliers: Partners that provide pharmaceutical products that have completed manufacturing and packaging.
■Contract manufacturers: Manufacturers commissioned by the Company to carry out pharmaceutical production or contract manufacturing.
■Active pharmaceutical ingredient (API) suppliers: Sources that provide the active ingredients of drugs.
TSH manages suppliers through qualification review, on-site audits, improvement guidance, and a follow-up mechanism, while promoting environmental friendliness and paying attention to sustainability issues, to build a sustainable supply chain.
The management policy covers four major aspects:
Quality management｜The Company evaluates suppliers’ quality systems and supply quality through questionnaires filled out by contracted manufacturers, on-site audits, and data reviews. We require suppliers to provide official inspection reports from the past three years, validPIC/S GMP documents, Taiwan FDA Drug Master File (DMF) registrations for active pharmaceutical ingredients, Certificates of Analysis from original manufacturers, and Material Safety Data Sheets (MSDS).
■Delivery time｜The Company selects credible and reliable suppliers to ensure timely delivery and reduce lead times. It establishes secondary material sources and finished product safety stock levels for inventory management to maintain supply stability.
■Service｜Vendors provide prompt quotations, complete documentation, deliver quality products meeting specifications, and demonstrate high cooperation. Willingness to promptly visit the facility to understand and resolve quality issues if problems arise.
■Sustainability and Human Rights | Encourage suppliers to obtain certifications such as ISO 14001, ISO 45001, and AED safe premises. The evaluation standards also cover basic human rights clauses such as the prohibition of child labor and the elimination of forced labor, and require the signing of a corporate social responsibility self-assessment questionnaire.
Supplier Evaluation Mechanism
To ensure supply chain stability and compliance with internal control and sustainability requirements, the Company has established a comprehensive mechanism—from “new supplier onboarding and screening” to “existing supplier classification and dual-track evaluation system”—in accordance with the “Supplier Management Procedures:”
1.New Supplier Screening
For new partners seeking inclusion in the Company’s qualified supplier list, we implement a strict qualification review and ESG screening to ensure they not only meet quality standards but also demonstrate environmental and social responsibility awareness.
■Qualification review: Suppliers are required to provide documents such as pharmaceutical manufacturer/distributor licenses, valid PIC/S GMP certificates, factory registration certificates, and the latest version of the Site Master File (SMF). ESG and quality evaluation: Evaluators conduct on-site inspections or perform documentary reviews through the “entrusted manufacturer questionnaire (including sustainability questionnaire).”
■The review aspects cover: quality system: manufacturing, quality assurance, warehousing, and validation systems. Sustainability indicators: Environmental management (such as ISO 14001), labor human rights, and occupational health and safety (such as ISO 45001).
2025 Screening Performance
In 2025, 1 new supplier (outsourced warehousing) was added, and 100% passed screening and on-site audits covering environmental, social, and quality standards, with evaluation results complying with GDP regulations.
2. Existing Supplier Classification and Dual-Track Evaluation System
To effectively manage risks, the Company implements a dual-track management mechanism of “annual comprehensive evaluation” and “periodic re-evaluation” for suppliers already included in the qualified supplier list, applying tiered management based on evaluation results.
Supply Chain ESG Engagement Practices and Effectiveness
Beyond quality and operating performance, the Company extends its management reach to environmental and social aspects through the “Supplier Corporate Social Responsibility Self-Assessment Questionnaire” and on-site visits. In 2025, the Company deepened its collaboration with key suppliers, with the following specific results:
1.New Supplier Screening
In 2025, 1 new supplier (outsourced warehousing) was added, and 100% passed screening and on-site audits covering environmental, social, and quality standards, with evaluation results complying with GDP regulations.
2.Periodic Re-Evaluation
In 2025, a total of 5 sites were audited this year (including 4 manufacturing plants and 1 warehouse), with audit results showing 100% compliance with GMP/GDP regulations.
3.Key Supplier ESG Performance (Engagement)
We encourage suppliers to respond to the CSR questionnaire (which will be renamed the ESG questionnaire after 2026) and obtain international certifications. The following are the specific ESG initiatives of key partners in 2025:
2025 Key Supplier ESG Performance Highlights
