Manufacturing of Amoxicillin trihydrate 500 mg Oral Capsules

The contract authorizes the large-scale manufacturing of 500 mg amoxicillin trihydrate oral capsules in both 60-count and 100-count bottle configurations, with full compliance to FDA and USP standards governing stability, potency, and sterility. The scope encompasses all phases of production including batch formulation, encapsulation, rigorous quality control testing, and assignment of accurate expiration dates to ensure product integrity throughout its shelf life. All manufacturing activities must adhere to current good manufacturing practices to guarantee consistent quality and safety for end-use patients. Production is to be performed at the designated place of performance in Bristol, Tennessee, with the contract issued under the U.S. Department of Health and Human Services through its Aspr/orm-Sns office. The work falls under NAICS code 325412, identifying it as pharmaceutical preparation manufacturing, and is structured as a subcontract with no set-aside provisions specified. The solicitation was posted on June 26, 2026, and all deliverables must meet federal regulatory requirements to ensure the capsules are suitable for clinical use and distribution within the U.S. healthcare system.