At Unibest, we pride ourselves on being the preferred partner for global pharmaceutical companies in search of premium active pharmaceutical ingredients (APIs). Our unparalleled expertise in sourcing top-tier pharmaceutical ingredients distinguishes us in the industry. Today, we're excited to share ten key insights on identifying and selecting the ideal API source. Discover more details in our comprehensive article.

Regulatory Compliance

Ensuring suppliers meet strict requirements set by regulatory bodies like FDA, EMA, and TGA, and adhere to current Good Manufacturing Practices (cGMP).

Quality Assurance

Examining quality control documentation and Certificates of Analysis to verify identity, purity, and stability of API batches.

Supply Chain Reliability

Evaluating suppliers based on production capacity, track record, and ability to meet demand consistently.

Safety Considerations

Ensuring comprehensive Safety Data Sheets (SDS) are provided and adhering to recommended safety guidelines for handling and transportation.

Intellectual Property

Conducting due diligence to avoid infringement on existing patents or IP restrictions in target markets.

Pricing and Terms

Negotiating favorable pricing and terms that reflect true market value while considering total cost of ownership.

Customs and Import Regulations

Navigating international trade complexities and ensuring smooth clearance of APIs across borders.

Documentation

Maintaining comprehensive records of all API transactions for traceability and quality assurance.

Testing and Verification

Conducting thorough testing upon receiving APIs to verify quality and specifications.

Storage and Handling

Adhering to supplier recommendations and industry best practices for storage conditions and handling protocols to maintain API potency.