Semaglutide Injection
12.5 mg/2.5 mL

Semaglutide Injection

NDC:
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Concentration:
Description:
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Active Ingredient:
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54288-831-01
Injectable
2.5 mL
12.5 mg/2.5 mL
12.5 mg/2.5 mL
2R Clear Glass Vial
Semaglutide
Rx Only
Subcutaneous

Frequently Asked Questions

Does the BPI product have to be reconstituted?

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

Why can BPI product be shipped unrefrigerated?

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.

How is BPI Semaglutide stored?

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.

What is the Beyond Use Date (BUD)?

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

What form of Semaglutide does BPI product use?

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.

Where is BPI Active Pharmaceutical Ingredients sourced from?

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.

How does BPI assure its Semaglutide API is the correct and safe form?

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.

What is a Drug Master File (DMF)?

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.

What are the inactive ingredients in BPI’s Semaglutide formulation ?

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

How does BPI assure product quality?

BPI is an FDA registered drug manufacturer who produces FDA approved sterile drugs usedd 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.

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