Semaglutide Injection

No, BPI formulation is a ready to use product that does not have to be reconstituted.

BPI has performed excursion studies that shows the product is stable at temperatures as high as 104°F for up to 5 days.  Once received, the product should be placed in the refrigerator.

BPI Semaglutide vials are intended to be stored under refrigeration between 2°C to 8°C (36°F to 46°F) and protected from freezing and light.

The product has 12 months dating from the manufacturing date when refrigerated.

BPI uses only the base form of Semaglutide, similar, to the FDA approved Semaglutide products currently on shortage.  BPI Semaglutide does not contain a sodium or acetate salt form.  Products containing salt forms have not been shown to be safe and effective.

Semaglutide  API (Active Pharmaceutical Ingredients) only comes from FDA registered and inspected manufacturers.  BPI has validated suppliers in Asia and Europe.  All suppliers are validated by BPI quality team.  BPI has validated several suppliers to ensure consistent supply of product.

BPI only uses Drug Master File (DMF) Active and Inactive ingredients to assure the purest materials are incorporated. BPI 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.

A Drug Master File (DMF) is a submission to the FDA that’s provides confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.  Only DMF material can be used for the filing of a human drug application with the FDA.

Disodium Phosphate Dihydrate, Sodium Chloride, Benzyl Alcohol and Water for Injection

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

Being a registered drug manufacturer that produces approved ANDA and NDA drugs, provides the confidence all BPI 503B drugs are made under the same robust standards.  BPI uses the same quality standards, same operating procedures and same commercial manufacturing equipment to make all 503B products as it does FDA approved drugs.

No, BPI Semaglutide is considered a compound drug.  Having an NDC number does not mean the product is FDA approved.

Since BPI is an FDA registered drug manufacturer, the FDA has issued BPI a labeler code (54288).  Due to our SOP’s, every product produced at BPI’s facility must have an NDC number. Additionally, the FDA has guidance stating drug manufactures with 503B license to issue a NDC to products.  This is unlike 503A compounding pharmacies that have no FDA oversight and are not issued any FDA labeler codes nor are required to list compounded items with the FDA.

BPI registers every 503B NDC with the FDA twice a year as per guidelines.  BPI has chosen not to list its Semaglutide NDC’s with the drug databases because it is not an approved drug nor is it applicable for insurance reimbursement.

BPI does not use any third party testing for its Semaglutide products.  BPI is a drug manufacture and as such, does all its own testing internally.  This level of full testing is the same quality procedures used for all of BPI’s FDA approved drugs.

The reason 503A pharmacies utilize third party testing is because they do not have their own internal testing capabilities and are required to provide some basic tests, such as potency.

BPI 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 best results for our consumers