USAntibiotics
USAntibiotics operates a large U.S.-based pharmaceutical manufacturing facility focused on production of amoxicillin-based oral antibiotics and authorized generics. Founded in 1978 and located in Bristol, Tennessee, the company operates a 394,000 sq. ft. plant with pilot-scale and full-scale production, in-house packaging, quality control laboratories, and regulatory affairs capacity. The organization emphasizes cGMP compliance, quality systems, domestic supply-chain resilience, and management of regulatory submissions for multiple NDAs.
Industries
Nr. of Employees
medium (51-250)
USAntibiotics
Products
Amoxicillin and clavulanate extended-release tablets — 1000 mg/62.5 mg
Extended-release oral tablet formulation of amoxicillin combined with clavulanate provided in commercial packaging (NDC 81964-220-28 and 81964-220-40).
Amoxicillin and clavulanate tablets and oral suspensions — multiple strengths
Immediate-release tablets (e.g., 875/125 mg) and powders for oral suspension in multiple strengths and pack sizes for pediatric and adult use.
Amoxicillin capsules and suspensions — 500 mg and pediatric suspensions
Finished dosage forms of amoxicillin in capsule (500 mg) and suspension formats with commercial packaging and NDC listings.
Amoxicillin and clavulanate extended-release tablets — 1000 mg/62.5 mg
Extended-release oral tablet formulation of amoxicillin combined with clavulanate provided in commercial packaging (NDC 81964-220-28 and 81964-220-40).
Amoxicillin and clavulanate tablets and oral suspensions — multiple strengths
Immediate-release tablets (e.g., 875/125 mg) and powders for oral suspension in multiple strengths and pack sizes for pediatric and adult use.
Amoxicillin capsules and suspensions — 500 mg and pediatric suspensions
Finished dosage forms of amoxicillin in capsule (500 mg) and suspension formats with commercial packaging and NDC listings.
Services
On-site manufacturing, formulation, packaging and serialization services for finished oral dosage forms of penicillin-class antibiotics and authorized generics.
On-site manufacturing, formulation, packaging and serialization services for finished oral dosage forms of penicillin-class antibiotics and authorized generics.
Expertise Areas
- Antibiotic manufacturing (oral solid and suspension formats)
- Solid oral dosage formulation and scale-up
- cGMP quality systems and compliance
- Regulatory affairs and NDA management
Key Technologies
- Tableting (tablet compression)
- Encapsulation
- Aqueous coating
- Dry granulation and sieving
News & Updates
Company announced FDA approval of an extended-release amoxicillin/clavulanate product via an expedited review pathway.
Company received a national priority voucher from FDA recognizing domestic manufacturing of a critical antibiotic.
Announcement of partnerships with major retail and distribution organizations to support domestic manufacturing and distribution of amoxicillin products.
Announcement describing reopening of the manufacturing facility and return of antibiotic production to domestic operations.
Company statement about readiness to support supply during amoxicillin shortages.
Company announced FDA approval of an extended-release amoxicillin/clavulanate product via an expedited review pathway.
Company received a national priority voucher from FDA recognizing domestic manufacturing of a critical antibiotic.
Announcement of partnerships with major retail and distribution organizations to support domestic manufacturing and distribution of amoxicillin products.
Announcement describing reopening of the manufacturing facility and return of antibiotic production to domestic operations.
Company statement about readiness to support supply during amoxicillin shortages.