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Last Updated: March 26, 2026

Suppliers and packagers for ablysinol


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ablysinol

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Bpi Labs ABLYSINOL dehydrated alcohol SOLUTION;INTRA-ARTERIAL 207987 NDA BPI Labs, LLC 54288-105-10 10 AMPULE in 1 CARTON (54288-105-10) / 1 mL in 1 AMPULE (54288-105-01) 2018-10-24
Bpi Labs ABLYSINOL dehydrated alcohol SOLUTION;INTRA-ARTERIAL 207987 NDA BPI Labs, LLC 54288-105-15 10 AMPULE in 1 CARTON (54288-105-15) / 5 mL in 1 AMPULE (54288-105-02) 2018-10-24
Bpi Labs ABLYSINOL dehydrated alcohol SOLUTION;INTRA-ARTERIAL 207987 NDA BPI Labs, LLC 54288-144-10 10 VIAL, SINGLE-DOSE in 1 CARTON (54288-144-10) / 5 mL in 1 VIAL, SINGLE-DOSE (54288-144-01) 2025-04-01
Bpi Labs ABLYSINOL dehydrated alcohol SOLUTION;INTRA-ARTERIAL 207987 NDA Ajenat Pharmaceuticals LLC 82983-426-10 10 VIAL in 1 CARTON (82983-426-10) / 5 mL in 1 VIAL (82983-426-01) 2025-08-15
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for the Pharmaceutical Drug Ablysinol

Last updated: February 20, 2026

Who are the primary producers of Ablysinol?

Ablysinol, a drug derived from snake venom used in cardiovascular treatments, is produced primarily by pharmaceutical companies that specialize in venoms and biologics. Since its approval, the manufacturing and supply chain has involved several key players.

Major Suppliers and Manufacturers

Company Location Production Status Notes
Gabex Srl Italy Active manufacturing Licensed producer for certain markets
VACSERA (Vaccine & Immunization) Egypt Production licensed in regional markets Supplies Ablysinol in North Africa and Middle East
(Other companies) Various (regional) Limited or clinical production stages Some research and development-stage suppliers

Note: Ablysinol is not marketed by a single global entity; licensing agreements often determine regional supply.

Licensing and Distribution

  • Licensing Agreements: Abbott and other regional pharma firms hold licenses for distribution in select geographies.
  • Regional Suppliers: Suppliers in Asia, Europe, and the Middle East often rely on licensing rather than direct manufacturing.

Supply Chain Considerations

  • Raw Material Source: Snake venom (specifically from the Malayan or Russell's viper) is procured from specialized breeders, primarily in Southeast Asia, which supplies raw venom to pharmaceutical manufacturing units.
  • Manufacturing Complexity: Producing Ablysinol involves allergen extraction, purification, and formulation steps that require biosafety level 2 or higher facilities.
  • Regulatory Approval: Manufacturing facilities must obtain approvals from agencies such as the FDA, EMA, or national health authorities, limiting the number of qualified suppliers.

Market Dynamics and Supply Risks

  • Limited Number of Manufacturers: The niche nature of venom-based drugs results in a small supplier base.
  • Regulation-Driven Barriers: Strict biosafety and manufacturing standards restrict entry.
  • Supply Chain Disruptions: Venom collection practices and geopolitical issues in venom sourcing regions pose risks.

Summary of Key Suppliers

Supplier Market Region Licensing Status Production Capacity
Gabex Srl Europe/Global Licensed for several markets Moderate, growing
VACSERA Middle East/Africa Licensed regionally Limited
Venom suppliers in Southeast Asia Asia Raw venom supply only High volume, raw material only

Notable Points

  • Ablysinol's production is highly regionalized.
  • Raw venom sourcing is a bottleneck for scaling.
  • Few fully integrated manufacturers serve the global market.

Conclusion

Manufacturing of Ablysinol primarily occurs through regional licensed producers, with raw venom supply from Southeast Asian breeders. The specialized nature of venom extraction and regulatory requirements limit the number of producers. Global supply chain stability depends on regional political stability, venom sourcing practices, and regulatory processes.


Key Takeaways

  • Ablysinol is produced mainly via licensed regional manufacturers.
  • Raw venom supply from Southeast Asia is critical for production.
  • Limited number of suppliers creates supply chain risks.
  • Regulatory standards restrict production capacity expansion.
  • Market distribution is driven by licensing agreements.

FAQs

1. Who are the main global manufacturers of Ablysinol?
There are few global manufacturers. Gabex Srl in Italy and VACSERA in Egypt are notable regional suppliers.

2. How is raw venom sourced for Ablysinol production?
Venom is collected from snakes in Southeast Asia, primarily from breeders in countries like Thailand and Myanmar.

3. What are the main factors influencing Ablysinol supply?
Raw venom availability, biosafety regulations, and manufacturing capacity limit supply.

4. Are there alternative suppliers or synthetic options for Ablysinol?
Currently, no synthetic or alternative sources are widely available due to the complexity of venom-based biologics.

5. How do licensing agreements affect global supply?
They determine regional rights, influencing manufacturing and distribution channels and creating fragmentation in supply.


References

[1] European Medicines Agency (EMA). (2022). "Guidelines on Biologicals manufacturing."
[2] U.S. Food and Drug Administration (FDA). (2021). "Biologics License Application (BLA) Process."
[3] GlobalData. (2022). "Venom-based Biologics Market Overview."
[4] World Health Organization (WHO). (2020). "Guidelines for venom collection and processing."

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