Pioneers in precision and innovation, dedicated to delivering excellence in every formulation.
BPI Labs, LLC, a subsidiary of Belcher Pharmaceuticals, a leading manufacturer of branded and generic injectable medications is proud to be one of a handful of FDA registered drug manufacturer and 503B. BPI’s strong quality culture, led by experienced professionals adhering to the strictest GMP regulations, is the cornerstone of our operations. Using cutting-edge isolation and human less robotic manufacturing technologies and all in-house analytical and microbiological testing, we maintain the absolute highest quality sterile injectable production to meet market demands.
BPI Labs is a FDA registered drug manufacturer and 503B outsourcing facility, providing the absolute highest quality medications to fill unmet needs. BPI services hospitals, clinics, and pharmacies throughout the US. As a leading drug manufacturer and 503B, we ensure the highest quality standards in every product we produce.
BPI Labs steadfast commitment to quality, is shaping the future of healthcare, one dose at a time.
BPI Labs, LLC., is committed to provide the highest quality pharmaceutical products in order to satisfy the needs of its clients and the health and safety of its customers, meeting or exceeding the statutory and regulatory requirements.
This is achieved through compliance with current Good Manufacturing Practices, continuous improvement culture, human talent development, strong relationship with clients and vendors, and process optimization.
As a leading 503B compounding pharmacy manufacturer, we ensure the highest standards of accuracy and quality in every product we create.
BPI’s is one of the most technologically advanced sterile manufacturing facilities in the country. The facility was designed with cGMP adherence in mind. Fully Human-Less Robotic Filling Technology
BPI’s 503B drugs are made under the strictest cGMP guidelines, uses the same commercial manufacturing equipment and follows the same quality systems and procedural standards as its other FDA approved drugs. BPI’s quality is far beyond reproach and is unequivocally the most reliable compounded drugs on the market. Our most recent FDA audit of our 503B resulted in approvals with no 483 observations.
BPI’s is one of the most technologically advanced sterile manufacturing facilities in the country. The facility was designed with cGMP adherence in mind. We provide easy ordering through our portal, which offers complete order and tracking management.
BPI is an FDA registered drug manufacturer and 503B outsourcing facility. All our compounded medications follow 21 CFR Part 210 and 211 (cGMP). Our licenses allows us to produce medications that can be sold to clinics, hospitals and pharmacies.
Every batch is fully tested in our full chemistry and microbiology labs within the facility to meet more strict, self generated guidelines and parameters. This provides full confidence in producing industry best results for our consumers through strict compliance with cGMP regulations. We do not rely on third-party manufacturers’ C of A to assure quality. All ingredients are tested in-house, upon arrival and must meet our strict standards and methods developed with our in-house QC chemistry lab and microbiology labs.
Arizona, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Mississippi, Nevada, New Jersey, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Wisconsin.
| 503A (Compound Pharmacy) | 503B (Outsourcing Facility) | BPI Labs (503B + FDA Drug Manufacturer) | |
|---|---|---|---|
| Regulatory Agency | State (State Board of Pharmacy) | Federal (FDA) and State (SBOP) | Federal (FDA) and State (SBOP) |
| Regulations | USP <795>, <797>, <800>, SBOP | FDA 21 CFR Part 210 and 211 (cGMP) | FDA 21 CFR Part 210 and 211 (cGMP) |
| Distribution | Patient Specific Only | May or may not be. Can be sold to pharmacies or Office Use | May or may not be. Can be sold to pharmacies or Office Use |
| Batch Size | 250 units | Limited; usually up to 25 liters | Unlimited; up to 500 liters |
| Raw Material | Need C of A | Require C of A and Manufacture withFDA registration | Only use DMF Material, validate,qualify and create STMs |
| Quality Systems | Pharmacist review their own work | Quality department in place | Full quality assurance department,independent of operations |
| Batch Testing | No Analytical Testing | Minimal; Outsourced | Full in process testing; All in house |
| Stability Dating / Beyond Use Date (BUD) | Literature Only | Minimal; Outsourced | Full stability protocol to establishBUD and expiration dates |
| Validation (Methods) | Literature | Outsourced; Minimal | Full validation |
| Environmental Monitoring | Every 6 Months | Per production batch | Exceed cGMP Requirements |
| Endotoxin | Required; Outsourced | Required; Outsourced | Required; In House |
| Impurities Testing | Not Required | Not Required | Required; In House |
| Release Testing; Potency | Not Required | Every batch; Outsourced | Every batch, including In Process; In House |
| Visual Inspection | Manual | Manual | Fully Automated; High Speed AI Equipment |
| Sterile Filling | Laminar Flow Hood | Laminar Flow Hood | ISO5 Robotic Aseptic Filling (Commercial) |
BPI Labs, LLC – a wholly owned subsidiary of Belcher Pharmaceuticals, LLC – is a leading manufacturer of generic injectable medications and sterile 503B outsourcing products. Our products are of the highest quality in the industry. And we strive to provide injectable products to help alleviate supply disruption and drug shortages.
Quality is the foundation of BPI Labs. Our strong quality culture is comprised of dedicated and highly skilled & experienced professionals working in strict adherence to the cGMP regulations. Through the use of robotic technologies, our pharmaceutical manufacturing produces the highest quality sterile injectables at competitive prices.
12393 Belcher Rd S.
Suite 450
Largo, FL 33773
