Compliance

A strong culture of compliance is essential to ensure we operate ethically and responsibly. Our comprehensive compliance program governs all aspects of our generic drug operations, fostering a culture of integrity and adherence to the highest standards. Here's how our program ensures we put patients first:

• Ensure Generic Equivalence: We adhere to the strictest FDA regulations throughout the development and manufacturing of our generic drugs. This dedication helps ensure our medications achieve therapeutic equivalence to their brand-name counterparts.
• Supply Chain Integrity: We prioritize quality from the very beginning. We maintain a robust quality management system to ensure the authenticity and quality of raw materials used in our generic drugs. This includes partnering with reputable suppliers and conducting regular audits to uphold these high standards.
• Strict Quality Control Measures: Our manufacturing facilities employ rigorous quality control procedures throughout the production process. This ensures that every batch of medication we produce meets the strictest specifications for quality, safety, and efficacy.
• Transparent Labeling and Communication: We are committed to providing clear and accurate information about our generic medications. Our labels and communications strictly adhere to FDA regulations, ensuring that healthcare professionals and patients have the information they need to make informed decisions.

Transparency is a cornerstone of our commitment to compliance. We believe that operating openly and ethically builds trust with healthcare professionals, patients, and the communities we serve. To demonstrate this commitment, we adhere to all applicable laws and regulations for generic drugs, including:

• FDA Regulations for Generic Drugs: We follow the FDA's regulations for Abbreviated New Drug Applications (ANDAs) and Current Good Manufacturing Practices (CGMPs) for generic drugs.
• Data Privacy Laws: We comply with regulations like HIPAA and FTC health privacy rules to safeguard patient information entrusted to us.
• Industry Codes: We follow ethical guidelines such as the PhRMA Code on Interactions with Healthcare Professionals.

Cranbury Pharma is committed to upholding the highest ethical standards in our interactions with healthcare professionals throughout California. We achieve this by adhering to all applicable laws and regulations, including the California Health and Safety Code Sections 119400-119402 (California Compliance Law).

To ensure ongoing compliance with the California Compliance Law, Cranbury Pharma has established a robust Comprehensive Compliance Program (CCP). This program reflects our commitment to ethical conduct and upholds the standards outlined in the law.

Your voice matters! Report any suspected violations of our policies or the law. You can report a compliance issue anonymously using one of the following methods:

• Ethics and Compliance Helpline: This hotline offers completely anonymous reporting. Call 844-956-3287 or report online via trispharma.ethicspoint.com.
• Supervisor or Manager: Concerns can be discussed directly with a supervisor.
• Human Resources Department: The HR department is available to receive reports and answer questions.
• Compliance Officer: Reports can be submitted directly to the Compliance Officer via email at legal@cranburypharma.com.
• Report ALL Cranbury product complaints (PQC) or adverse drug experiences (ADE) ASAP, within 1 business day
  • Call (732-940-0358) or email:
    • ProductComplaints@trispharma.com (PQC)
    • DrugSafety@trispharma.com (ADE)