Business Details
FDA-Registered 503B Pharmaceutical Compounding Services
Hybrid Pharma stands as a leader in formulating high-quality sterile and non-sterile pharmaceutical compounds for human and animal use. As an FDA-registered 503B outsourcing facility, we specialize in producing limited-quantity medications during shortages while adhering to stringent quality standards. Our cleanroom suite exceeds USP <797> requirements, and our quality control laboratory operates under cGMP guidelines with state-of-the-art analytical equipment. With a team of experienced pharmacists, technicians, and chemists, we focus on modifying existing formulations and developing new ones to enhance stability and bioavailability.Our mission centers on delivering medications of unmatched quality and purity to healthcare providers while prioritizing patient safety through rigorous sterility and stability testing. We serve hospitals, clinics, and outpatient centers with injectable medications and customized compounding solutions. Our commitment to exceeding industry standards is reflected in our bi-annual facility certifications, frequent environmental monitoring, and adherence to both USP and cGLP protocols. By integrating scientific expertise with advanced manufacturing practices, we address critical medication needs and contribute to improved patient outcomes.
Services
Sterile Compounding
Non-Sterile Compounding
Quality Control Testing
Formulation Development
Clinical Trial Support
Injectable Medications
Community Pharmacy Services
Research & Development
Medication Delivery
E-Script Processing
Highlights and features
- We operate as an FDA-registered 503B outsourcing facility with federal compliance oversight.
- Our cleanroom exceeds USP requirements with bi-annual independent certification.
- We employ state-of-the-art analytical equipment for cGMP-compliant quality testing.
- Our team includes pharmacists and chemists with expertise in formulation development.
- We maintain rigorous environmental monitoring with quarterly viable air sampling.
Services
Sterile Compounding
We produce sterile injectable medications including intramuscular, intravenous, and subcutaneous formulations under USP guidelines. Our cleanroom facilities exceed federal standards with bi-annual certification. Pharmacists prepare customized sterile compounds for hospitals and clinics during drug shortages.
Non-Sterile Compounding
Our non-sterile compounding includes oral, sublingual, and topical medications tailored to specific patient needs. We develop formulations with enhanced bioavailability using advanced pharmaceutical chemistry techniques. All preparations follow strict quality assurance protocols for consistency and purity.
Quality Control Testing
We conduct comprehensive sterility, stability, and purity testing using HPLC, UV spectrophotometry, and osmometry. Our laboratory performs both in-house and third-party validation to ensure compliance with cGMP and USP standards for all compounded products.
Formulation Development
Our scientists specialize in improving existing drug formulations and creating new compounds with enhanced stability and bioavailability. We develop customized solutions for clinical trials and commercial applications using validated research methodologies and pharmaceutical engineering techniques.
Community Pharmacy
We provide compounded and commercial medications to individual patients with prescriptions. Our services include e-script processing, insurance billing, and delivery options for both sterile and non-sterile medications while maintaining compliance with state pharmacy regulations.
Questions
What services does Hybrid Pharma provide?
We specialize in sterile and non-sterile pharmaceutical compounding, 503B outsourcing, formulation development, quality control testing, and medication delivery for healthcare providers.
What is a 503B outsourcing facility?
As FDA-registered 503B facilities, we produce sterile compounded medications in bulk quantities during shortages under cGMP regulations with federal oversight.
How does Hybrid Pharma ensure medication quality?
We maintain USP <797>-compliant cleanrooms, perform sterility and stability testing, conduct quarterly air sampling, and use validated protocols for all analytical testing.
Do you accept insurance for pharmacy services?
Yes, we accept Medicare, Medicaid, Workers' Compensation, and most major insurance plans for compounded and commercial medications.
Can Hybrid Pharma compound medications for animals?
Yes, we formulate sterile and non-sterile compounds for both human and veterinary applications under FDA-regulated conditions.
