Last updated: May 31, 2026
GVOKE HypoPen (prufa-pi?): Who supplies it, who manufactures it, and what supply-chain/IP constraints matter
Executive summary: Gvoke HypoPen is supplied in the US market by Xeriant Pharmaceuticals, LLC (brand sponsor/distributor) under the Epinephrine autoinjector portfolio. The device-and-drug combination is manufactured under contract, with the drug substance and filled-device supply chain tied to alkaline-stability epinephrine formulation and autoinjector fill-finish controls typical for adrenaline products. Exact contract manufacturer identities for the HypoPen fill-finish and device are not recoverable from the provided inputs.
Who makes Gvoke HypoPen in the US market?
Short answer: Xeriant Pharmaceuticals, LLC is the US brand supplier/distributor for GVOKE HypoPen. The actual manufacturing entities for drug substance and the filled autoinjector are contract-based and require product-level label/manufacturing-site disclosures.
What supply-chain roles exist for an epinephrine autoinjector?
- Labeler/brand owner: US commercial sponsor (lists on the FDA label).
- Drug product manufacturer (fill-finish): manufactures the filled pen cartridge/needle assembly.
- Device maker: supplies the autoinjector mechanism (springs, needles, housings) integrated with the filled drug component.
- Quality system interfaces: primary packaging, subassembly traceability, and stability qualification for epinephrine (oxidation and light exposure controls).
What companies supply the drug product fill-finish for Gvoke HypoPen?
Short answer: Not determinable from the provided information.
Which fill-finish constraints drive supplier selection?
- Epinephrine chemical stability: formulation includes excipients and pH/antioxidant strategy to limit oxidative degradation.
- Particulate and closure integrity: sterility assurance and container-closure testing.
- Dose accuracy for autoinjectors: valving, needle actuation consistency, and dead-volume controls.
Who supplies the autoinjector device used in Gvoke HypoPen?
Short answer: Not determinable from the provided information.
Device components typically governed by supplier qualification
- Needle gauge and insertion reliability
- Actuation force tolerance
- Spring energy variance and delivery time window
- Safety interlock and needle shielding mechanisms
What is the FDA regulatory and labeling trail for Gvoke HypoPen supply?
Short answer: The most direct path is the US prescribing information and its “Manufactured for” / “Distributed by” lines, plus the label’s listing of manufacturer name and address. Those label-level manufacturing details are not included in the provided inputs.
Orange Book and device-drug combination implications
- Autoinjectors like Gvoke are regulated as drug products, but the product is a combination of drug and delivery device. Manufacturing responsibility typically appears in the label and in establishment listings, not in the Orange Book alone.
How many different suppliers are in the Gvoke HypoPen value chain?
Short answer: At least two supplier tiers are typical (brand sponsor and contract manufacturer), and often three (device, fill-finish, distribution). Exact counts for Gvoke HypoPen are not determinable from the provided information.
Common procurement structure for pen autoinjectors
- Long-term supply for:
- drug product filling and sterile processing
- device mechanisms and assembly
- Qualified alternates for:
- needle components
- subassemblies and packaging
What supplier-switching risks exist for epinephrine autoinjectors like Gvoke HypoPen?
Short answer: Supplier switches are constrained by container-closure qualification, delivery performance equivalence, and stability data expectations.
Key change-control triggers that slow or block substitution
- Needle actuation changes that affect delivered volume profile
- Changes in materials that affect epinephrine adsorption or leachables
- Container-closure substitute that impacts oxidation or light exposure
Which contract manufacturing organizations commonly support US epinephrine autoinjectors?
Short answer: Not determinable from the provided information.
Why generic “CDMO” lists are insufficient here
- The “right CDMO” for autoinjectors is specific to:
- sterile fill-finish capability for epinephrine
- autoinjector integration with validated device mechanics
- experience with stability and particulate controls for pen cartridges
Is Gvoke HypoPen supplied under any known licensing or exclusivity arrangement that affects manufacturing?
Short answer: Not determinable from the provided information.
What to look for in agreements and regulatory filings
- Manufacturing and supply agreements tied to brand exclusivity
- Supplement approvals requiring demonstrated comparability after supplier changes
What commercial/operational metrics determine supplier performance for Gvoke HypoPen?
Short answer: Not determinable from the provided information.
Supplier KPI set used in drug-device supply chains
- Fill-finish yield and OOS/OOE rates
- Sterility assurance pass rates
- Autoinjector actuation success and delivered dose accuracy
- On-time delivery and lead time for needle/device subcomponents
Key Takeaways
- Xeriant Pharmaceuticals, LLC is the US supplier/distributor for GVOKE HypoPen.
- Specific contract suppliers (drug fill-finish and autoinjector device manufacturer) are not identifiable from the provided inputs.
- For epinephrine autoinjectors, supplier substitution is constrained by epinephrine stability, container-closure interactions, sterile fill-finish controls, and autoinjector delivery performance equivalence.
FAQs
- What company is listed as “Distributed by” on the Gvoke HypoPen label?
- Do Gvoke HypoPen suppliers differ from other epinephrine autoinjectors like Auvi-Q, EpiPen, or Symjepi?
- What manufacturing sites typically appear for drug-device combination autoinjectors in US labeling?
- What supply-chain controls matter most for epinephrine oxidation and stability in an autoinjector?
- How do FDA requirements for change control affect switching the fill-finish or device manufacturer for an autoinjector?
References
- FDA. Labeling and prescribing information for Gvoke HypoPen (not provided in the input).
- FDA. Orange Book and drug product listing for Gvoke HypoPen (not provided in the input).
