SustainabilitySASB Index

Sustainability Disclosure Topics & Accounting Metrics

Safety of Clinical Trial Participants Discussion, by world region, of management process for ensuring quality and patient safety during clinical trials HC-BP-210a.1 CROs that meet standards in compliance with the laws and regulations of each country applicable to Sawai Group companies are selected. Especially, in the US, on site monitors are used to oversee study procedures for trials to assure procedures are completed and documented per GCP. Upsher-Smith provides continuous feedback to CROs to improve clinical study report and service quality.
Number of FDA Sponsor Inspections related to clinical trial management and pharmacovigilance that resulted in: (1) Voluntary Action Indicated (VAI) and (2) Official Action Indicated (OAI) HC-BP-210a.2 Nothing that has not been solved
Total amount of monetary losses as a result of legal proceedings associated with clinical trials in developing countries HC-BP-210a.3 The main markets of Sawai group are Japan and the United States, with very little business in developing countries.
Access to Medicines Description of actions and initiatives to promote access to healthcare products for priority diseases and in priority countries as defined by the Access to Medicine Index HC-BP-240a.1 No business in priority countries
List of products on the WHO List of Prequalified Medicinal Products as part of its Prequalification of Medicines Programme (PQP) HC-BP-240a.2 Not applicable
WHO Public Assessment Reports - Medicines
Afordability & Pricing Number of settlements of Abbreviated New Drug Application (ANDA) litigation that involved payments and/or provisions to delay bringing an authorized generic product to market for a defined time period HC-BP-240b.1 Not disclosed
Percentage change in: (1) average list price and (2) average net price across U.S. product portfolio compared to previous year HC-BP-240b.2 Not disclosed
Percentage change in: (1) list price and (2) net price of product with largest increase compared to previous year HC-BP-240b.3 Not disclosed
Drug Safety List of products listed in the Food and Drug Administration’s (FDA) MedWatch Safety Alerts for Human Medical Products database HC-BP-250a.1 Available via the FDA Adverse Reporting Website
MedWatch: The FDA Safety Information and Adverse Event Reporting Program
Number of fatalities associated with products as reported in the FDA Adverse Event Reporting System HC-BP-250a.2 Available via the FDA Adverse Reporting Website
MedWatch: The FDA Safety Information and Adverse Event Reporting Program
Number of recalls issued, total units recalled HC-BP-250a.3 Sawai Pharmaceutical:
ESG Data (Social)
No product recalls in 2020
Total amount of product accepted for take-back, reuse, or disposal HC-BP-250a.4 Not disclosed
Number of FDA enforcement actions taken in response to violations of current Good Manufacturing Practices (cGMP), by type HC-BP-250a.5 No FDA inspections in 2020
Counterfeit Drugs Description of methods and technologies used to maintain trace ability of products throughout the supply chain and prevent counterfeiting HC-BP-260a.1 Sawai Pharmaceutical:
We have introduced tamper-evident labels.
Sawai Pharmaceutical Press release
Initiatives are being pursued by Upsher-Smith and the pharmaceutical supply chain as required under the Drug Supply Chain Security Act (DSCSA). The DSCSA is being implemented in phases, with final compliance currently set for November 2023. At this time, Upsher-Smith products are identified and traced in accordance with DSCSA using product identifiers contained on the product label, including serial number, Global Trade Item Number (GTIN), Lot and Expiration.
Discussion of process for alerting customers and business partners of potential or known risks associated with counterfeit products HC-BP-260a.2 Sawai Pharmaceutical:
In the event Sawai were to be made aware of the existence of a counterfeit Sawai product on the market, Sawai would contact the Ministry of Health, Labour and Welfare concerning the steps to take.
Upsher-Smith has not been made aware, directly or indirectly, that any of its products are subject to counterfeiting. Counterfeit drugs are relatively rare in the US, and most counterfeit drugs are for chronic conditions for which USL does not market its products (including for the treatment of chronic diseases such as erectile dysfunction (ED), high cholesterol, and hypertension) or antibiotics, cancer and HIV/AIDS treatments). In the event Upsher-Smith were to be made aware of the existence of a counterfeit Upsher-Smith product on the market, Upsher-Smith would contact the FDA concerning the steps to take, which may include direct notification of customers and may also include the issuance of a press release detailing the presence in the market of a suspected counterfeit USL drug product.
Number of actions that led to raids, seizure, arrests, and/or filing of criminal charges related to counterfeit products HC-BP-260a.3 ESG Data (Governance)
Ethical Marketing Total amount of monetary losses as a result of legal proceedings associated with false marketing claims HC-BP-270a.1 Not disclosed
Description of code of ethics governing promotion of off-label use of products HC-BP-270a.2 Sawai Pharmaceutical:
Sawai Pharmaceutical Corporate Philosophy
Upsher-Smith Code of Business Conduct
Employee Recruitment, Development & Retention Discussion of talent recruitment and retention efforts for scientists and research and development personnel HC-BP-330a.1 Description at the bottom*
(1) Voluntary and (2) involuntary turn over rate for: (a) executives/seniormanagers, (b) mid-level managers, (c) professionals, and (d) all others HC-BP-330a.2 Sawai Pharmaceutical:
Employee turnover, retention rate of new graduates (after 3 years of employment)
ESG Data (Social)
Not disclosed
SupplyChain Management Percentage of (1) entity's facilities and (2) Tier 1 suppliers' facilities participating in the Rx-360 International Pharmaceutical Supply Chain Consortium audit program or equivalent third-party audit programs for integrity of supply chain and ingredients HC-BP-430a.1 Percentage of (1) 0%
Percentage of (2) 0%
Business Ethics Total amount of monetary losses as a result of legal proceedings associated with corruption and bribery HC-BP-510a.1 Sawai Pharmaceutical and Upsher-Smith
ESG Data (Governance)
Description of code of ethics governing interactions with health care professionals HC-BP-510a.2 Sawai Pharmaceutical:
Sawai Pharmaceutical Corporate Philosophy
Upsher-Smith Code of Business Conduct
Number of patients treated HC-BP-000.A Sawai Pharmaceutical:
Accounting for about 8% of the volume of drugs sold domestically (according to our analysis 2020)Upsher-Smith:
Not disclosed
Number of drugs (1) in portfolio and (2) in research and development (Phases1-3) HC-BP-000.B (1) Number of drugs in portfolio
Sawai Pharmaceutical:
ESG Data (Social)
Upsher-Smith Products

(2) Number of drugs in research and development stage (Phases 1-3)
Sawai Pharmaceutical:
Planning to launch of over 85 products in the next three years.
Long-Term Vision and Mid-Term Business Plan Upsher-Smith:
Planning to launch over 30 products in the next three years.
Long-Term Vision for 2030 and Medium-Term Business Plan (P30)

Sawai Pharmaceutical:
[Quantitative situation]
ESG Data (Social)

[Qualitative situation]

  • Internships in R&D positions are offered to volunteers during recruitment activities for new employees.
    The training includes online group work on company outlines, lectures on formulation technology, and learning what is required for generic drugs.
    An understanding of Sawai Pharmaceutical's R&D is gained since prior to entry into the company.
  • In the introductory training, new employees receive lectures from the management group, in order to create a sense of unity and team spirit with the early penetration of Sawai Pharmaceutical's vision.
  • Recruitment page 

We have Corporate Programs that all employees are eligible to participate in, including scientists:

  • Mentoring Opportunities
    Upsher-Smith offers Mentoring opportunities to employees through several options: Speed Networking sessions, Group Mentoring (discussion groups on specific topics), Individual Mentoring (1:1 mentoring with a USL leader), Peer to Peer Mentoring and Reverse Mentoring.
  • Career Development
    Employees are encouraged to complete an Individual Development Plan (IDP) in Workday. This Plan is reviewed with the employee’s manager with specific action items around further development. Upsher-Smith offers development opportunities through USL University (internal training programs) and Upsher-Smith also partners with Universities which offer external leadership development courses for employees.
  • Incentive Structure
    Scientists participate in the Upsher-Smith Annual Incentive Plan (AIP). We also have a Corporate Recognition Program, USL Rewards, in which employees receive recognition points that they can use towards purchasing various items or gift cards.

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