USAntibiotics LLC
USAntibiotics operates a large-scale pharmaceutical manufacturing facility in Bristol, Tennessee (394,000 sq ft) focused on producing finished oral dosage forms of amoxicillin and amoxicillin–clavulanate antibiotics. Founded in 1978 and part of the Jackson Healthcare group since 2021, the company emphasizes domestic production capacity, cGMP compliance, quality systems, and regulatory engagement to support national supply chain resilience.
Industries
N/A
Nr. of Employees
medium (51-250)
USAntibiotics LLC
201 Industrial Drive Bristol, Tennessee 37620
Products
Amoxicillin for Suspension, 400 mg per 5 mL
Oral antibiotic powder for reconstitution available in multiple bottle sizes (50 mL, 75 mL, 100 mL).
Amoxicillin capsules, 500 mg
Oral antibiotic capsules supplied in 100-count and 500-count packages.
Amoxicillin–clavulanate for suspension and tablets
Oral antibiotic combinations available as powders for suspension (multiple strengths and volumes) and immediate- and extended-release tablets.
Amoxicillin for Suspension, 400 mg per 5 mL
Oral antibiotic powder for reconstitution available in multiple bottle sizes (50 mL, 75 mL, 100 mL).
Amoxicillin capsules, 500 mg
Oral antibiotic capsules supplied in 100-count and 500-count packages.
Amoxicillin–clavulanate for suspension and tablets
Oral antibiotic combinations available as powders for suspension (multiple strengths and volumes) and immediate- and extended-release tablets.
Services
Manufacture and packaging of tablets, capsules and powders for oral suspension for amoxicillin-class antibiotics; capacity to supply large volumes.
Quality assurance, regulatory affairs and pharmacovigilance functions supporting marketed products and NDAs.
Manufacture and packaging of tablets, capsules and powders for oral suspension for amoxicillin-class antibiotics; capacity to supply large volumes.
Quality assurance, regulatory affairs and pharmacovigilance functions supporting marketed products and NDAs.
Expertise Areas
- Antibiotics manufacturing
- Finished oral dosage form production
- Regulatory compliance and NDA management
- Quality assurance and pharmacovigilance
Key Technologies
- Tableting and encapsulation
- Dry granulation and sieving
- Aqueous coating
- Powders for oral suspension manufacturing
News & Updates
Award of an FDA national priority review voucher to support expedited regulatory review and expanded domestic production.
Partnerships with large distributors to support domestic manufacturing and supply of amoxicillin products.
Leadership appointment to oversee manufacturing technologies and operations.
Leadership appointment for quality and regulatory affairs functions.
Opinion piece linking domestic manufacturing to alleviation of drug shortages.
Received an FDA national priority voucher to support expedited regulatory review for a critical antibiotic.
Award of an FDA national priority review voucher to support expedited regulatory review and expanded domestic production.
Partnerships with large distributors to support domestic manufacturing and supply of amoxicillin products.
Leadership appointment to oversee manufacturing technologies and operations.
Leadership appointment for quality and regulatory affairs functions.
Opinion piece linking domestic manufacturing to alleviation of drug shortages.
Received an FDA national priority voucher to support expedited regulatory review for a critical antibiotic.