Every pharmaceutical company – whether it produces innovative brand-name, generic or biologic drugs – must adhere to the same manufacturing practices and strict quality control procedures necessary to manage a complex, global network of suppliers and distributors. In addition to complying with all government regulations, Teva has taken additional steps to further strengthen our supply chain and promote safety, including voluntary supplier audits. Teva’s manufacturing process specifically includes:

• FDA Approval – Similar to the drug approval process, the FDA sets the highest standards for the production and distribution of medications. These regulations govern the sourcing, chemistry and manufacturing controls for each product, and all Teva plants meet or exceed current Good Manufacturing Practices (cGMP).

• Proven Partners – In addition to relying on FDA inspection reports and cGMP certifications, Teva also works with trusted suppliers and conducts onsite facility audits to verify these vendors meet our exacting standards. We validate that each manufacturing site has established proper controls for providing consistently high-quality products.

• Rigorous Testing – We physically inspect each shipment and perform analytic tests using FDA methods to verify compliance with pre-established acceptance specifications. We also retain a sample for future investigation, if necessary.

• Ongoing Monitoring & Reporting – Once our drugs are on pharmacy shelves, Teva tracks patient reports and monitors for trends. Our quality reporting system is designed to identify any potential problems and evaluate if further action is warranted. We also submit annual product reports to FDA.

Continuous Improvements

As new challenges to drug safety emerge, Teva works with government officials, industry partners, patient representatives and other key stakeholders to develop smart, effective responses. We strongly support efforts to deter drug counterfeiting and strengthen inspections of domestic and foreign facilities.

• Prescription Drug Anti-Counterfeiting – Threats to the integrity of the drug supply represent a national problem that requires a national solution rather than the current patchwork of state-by-state plans. Real-world experience shows that counterfeiters typically target high-priced drugs with strong consumer demand, and deterrent efforts should start with these at-risk medications. Any anti-counterfeiting system should use proven technology, be phased in so there is no disruption of patient access to medicines and apply to all manufacturers, including contract suppliers, packagers and other third-party entities.

• Foreign Inspections – In a global marketplace, foreign facilities should be held to the same standards as domestic plants, including government inspections at least once every two years and more frequently if FDA detects problems. Teva supports: 1) taking a risk-based approach that allows FDA to focus on areas with a higher potential for concerns, 2) charging facility fees to finance inspection, including additional charges for re-inspection, and 3) establishing an on-the-ground presence in countries with a large share of registrations and cited problems