BPI Labs stands out as both a Licensed Drug Manufacturer and a 503B Outsourcing Facility, setting a new standard in pharmaceutical manufacturing. Our products are manufactured in ISO5 clean environments using state-of-the-art robotic filling technology, ensuring precision and sterility in every batch. This advanced approach contrasts sharply with most other 503A and 503B facilities, which rely on human technicians and laminar flow hoods for their compounding and filling processes. By leveraging cutting-edge automation, we enhance product consistency, safety, and quality, delivering superior outcomes for patients and healthcare providers alike.

BPI Labs exclusively uses the base form of Tirzepatide and Semaglutide, identical to the FDA-approved GLP-1 products currently listed on shortage. Our GLP-1s do not include any sodium or acetate salt forms. It is important to note that products containing salt forms of Semaglutide and Tirzepatide have not demonstrated the same level of safety and efficacy. By using the base form, we ensure that our products meet the highest standards of quality and reliability.

BPI Labs' formulation is a ready-to-use solution, eliminating the need for reconstitution before administration to your patients. This ensures convenience, efficiency, and accuracy in dosing, enhancing the overall patient care experience.

The Tirzepatide and Semaglutide API (Active Pharmaceutical Ingredient) used by BPI Labs is exclusively sourced from validated FDA-registered manufacturers, all of whom have a Drug Master File (DMF) listed with the United States FDA.

BPI Labs only uses (DMF) Drug Master File active ingredients along with inactive ingredients to assure the purest ingredients are incorporated. BPI Labs does not rely on an API manufacturer C of A to assure quality. All API and inactive ingredients are tested upon arrival and must meet our strict standards and methods that are developed with our in- house QC chemistry lab and microbiology labs.

Our formulation contains Disodium Phosphate Dihydrate, serving as a preservative, Sodium Chloride to help prevent dehydration, Benzyl Alcohol as a solvent, and Water for Injection.

BPI Labs adheres to a strict policy of using only Tirzepatide and Semaglutide without any additional active ingredients. Unlike some compounding pharmacies that may incorporate vitamins or other medications, our Tirzepatide and Semaglutide formulation remains pure and focused solely on delivering the proven benefits of these GLP-1s. This approach prioritizes safety and efficacy, ensuring that our product maintains the highest standards of quality and reliability for patient care.

BPI Labs is an FDA registered drug manufacturer who produces commercial sterile products utilized throughout hospitals nationwide. BPI Labs is also a registered 503B Outsourcing Facility which executes with full cGMP operations with no difference from our commercial products.

BPI Labs has full chemistry and microbiology labs within our facility that allow us to meet more strict, self-generated guidelines and parameters. This way, we provide full confidence in producing industry leading results for our medical partners and their patients.

BPI has performed excursion studies that shows the our Semaglutide is stable for 15 days at temperatures as high as 95°F. Based on this, all of our GLP-1s are shipped to our customers or your patients without the need of cold packs.

BPI Labs is a FDA Registered Drug Manufacturer along with a 503B Outsourcing Facility. BPI Labs is one of only a few companies in the country that carry this dual licensure.

BPI Labs parent company is a Licensed Drug Manufacturer that produces commercially approved ANDA and NDA drugs, which provides the confidence that its medications are made under the same stringent standards as a pharmaceutical manufacturer. BPI Labs uses the same quality standards and same operating procedures to make all of Its 503B products as it does Its FDA approved drugs.

BPI Labs carries dual licensure as a Drug Manufacturer and a 503B Outsourcing Facility. They do this to support nationwide drug shortages, ensuring customers have access to the medications they need. The compounded medications BPI Labs sells are on the FDA drug shortage list and therefore have they have met the requirements to manufacture and sell these products.