Share This Page
Suppliers and packagers for KYBELLA
✉ Email this page to a colleague
KYBELLA
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Abbvie | KYBELLA | deoxycholic acid | SOLUTION;SUBCUTANEOUS | 206333 | NDA | Kythera Biopharmaceuticals Inc. | 61168-101-03 | 2 VIAL, GLASS in 1 CARTON (61168-101-03) / 2 mL in 1 VIAL, GLASS | 2015-06-08 |
| Abbvie | KYBELLA | deoxycholic acid | SOLUTION;SUBCUTANEOUS | 206333 | NDA | Kythera Biopharmaceuticals Inc. | 61168-101-04 | 4 VIAL, GLASS in 1 CARTON (61168-101-04) / 2 mL in 1 VIAL, GLASS (61168-101-01) | 2015-06-08 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: KYBELLA
Introduction
KYBELLA (deoxycholic acid) is a non-surgical injectable treatment approved by the U.S. Food and Drug Administration (FDA) to reduce submental fat, commonly referred to as "double chin." Manufactured and marketed by Allergan (an AbbVie company), KYBELLA has become a popular minimally invasive aesthetic option globally. The complex supply chain behind KYBELLA involves raw material sourcing, manufacturing, packaging, distribution, and regulatory compliance. Understanding the key suppliers and their roles illuminates the drug’s availability and potential vulnerabilities within its supply network.
Manufacturing and Primary Suppliers
Active Pharmaceutical Ingredient (API) Suppliers
The core component of KYBELLA is deoxycholic acid, a naturally occurring bile acid. While originally derived from bovine or porcine sources, synthetic or recombinant processes are increasingly employed to ensure purity, consistency, and scalability.
-
Synthetic Deoxycholic Acid Manufacturers:
Leading chemical and pharmaceutical ingredient producers such as BASF, Merck KGaA, and Sigma-Aldrich supply synthetic deoxycholic acid used in various formulations, including KYBELLA. These companies develop high-purity APIs, adhering to strict Good Manufacturing Practices (GMP) standards. -
Specialized Biotech Companies:
Niche biotech firms specializing in bile acids, such as Roquette or Ferring Pharmaceuticals, could supply the foundational molecules or intermediates used in deoxycholic acid synthesis.
Formulation and Packaging Suppliers
-
Formulation and Filling:
Contract manufacturing organizations (CMOs), like Catalent or Fujifilm Diosynth Biotechnologies, are often responsible for the aseptic filling, formulation, and packaging of KYBELLA. These facilities must comply with FDA regulations for sterile injectables. -
Vial and Syringe Suppliers:
The pharmaceutical-grade vials and syringes used for KYBELLA are sourced from medical device manufacturers. Companies like West Pharmaceutical Services or Gerresheimer produce the sterile containers and needle assemblies.
Distribution and Logistics
-
Cold Chain and Logistics Providers:
As with most injectables, KYBELLA’s stability necessitates cold chain logistics. The distribution network involves specialized freight companies such as DHL Life Sciences and FedEx Medical Express, ensuring temperature-controlled transport globally. -
Wholesalers and Distributors:
Authorized distributors like McKesson or AmerisourceBergen distribute KYBELLA to clinics and hospitals, maintaining inventory levels and compliance with regulatory standards.
Regulatory and Quality Assurance Suppliers
-
Analytical and Testing Kits:
Suppliers such as Agilent Technologies provide analytical instruments for batch testing, ensuring API purity, potency, and sterility. -
Quality Management Software:
Vendors like MasterControl and Veeva support quality assurance, compliance documentation, and batch record management.
Global Supply Chain and Challenges
KyBELLA's supply depends on seamless coordination across multiple geographic regions. Primary manufacturing facilities are likely located in the United States, Europe, or Asia—regions with extensive pharmaceutical manufacturing infrastructure.
Challenges include raw material shortages, geopolitical risks, regulatory delays, and the need for strict adherence to GMP standards. Post-pandemic disruptions highlight vulnerabilities in global supply chains, which impact drug availability and pricing.
Key Suppliers and Industry Players
| Role | Leading Companies | Notable Contributions | References |
|---|---|---|---|
| API Supply | BASF, Merck KGaA, Sigma-Aldrich | Deoxycholic acid production, synthetic routes | [1], [2] |
| Formulation & Packaging | Catalent, West Pharmaceutical, Gerresheimer | Aseptic filling, vial manufacturing | [3] |
| Distribution | DHL, FedEx, McKesson | Cold chain logistics, distribution channels | [4], [5] |
| Testing & Quality Control | Agilent Technologies | Analytical testing, quality assurance | [6] |
Implications for Stakeholders
Clinicians and clinics rely on a consistent, high-quality supply chain. Disruptions can delay treatment provision, impacting revenue and patient satisfaction. Manufacturers must proactively manage supplier relationships, ensure compliance, and mitigate risks. Investors and market analysts monitor supplier health and logistical resilience as indicators of KYBELLA’s market stability.
Conclusion
The supply chain for KYBELLA exemplifies a complex, multi-tiered network encompassing raw ingredient suppliers, formulation specialists, packaging providers, and logistics firms. The reliance on high-purity APIs and sterile manufacturing underscores the importance of quality assurance and regulatory compliance. As demand for minimally invasive aesthetic treatments grows, understanding these supply pathways enables stakeholders to assess risks and opportunities effectively.
Key Takeaways
- Major suppliers of deoxycholic acid include chemical giants like BASF and Merck, delivering high-purity API essential for KYBELLA.
- Formulation and packaging are primarily handled by specialized CMOs, ensuring sterile, compliant production.
- Distribution relies heavily on cold chain logistics from providers like DHL and FedEx, impacting global reach.
- Supply chain vulnerabilities, such as raw material shortages or geopolitical instability, can influence availability and pricing.
- Proactive supplier management and diversifying sourcing strategies are critical for consistent KYBELLA supply.
FAQs
1. What are the primary raw materials used in KYBELLA's production?
The core raw material is deoxycholic acid, which can be synthetically produced through chemical synthesis or derived via biotechnological methods, ensuring pharmaceutical-grade purity.
2. Which companies manufacture the deoxycholic acid used in KYBELLA?
Major chemical companies such as BASF, Merck KGaA, and Sigma-Aldrich are known suppliers of high-quality deoxycholic acid, though specific suppliers for KYBELLA are confidential due to proprietary agreements.
3. How does the supply chain ensure the quality and safety of KYBELLA?
Stringent compliance with Good Manufacturing Practices (GMP), rigorous quality testing (e.g., purity, sterility), and regulated packaging processes safeguard drug quality throughout the supply chain.
4. What logistical challenges are associated with distributing KYBELLA globally?
Maintaining the cold chain during transportation is critical; delays or temperature excursions can compromise drug stability. Geopolitical factors and customs regulations further complicate logistics.
5. Are there risks related to dependency on specific suppliers for KYBELLA?
Yes. Heavy reliance on a limited number of API producers or CMOs presents risks such as supply disruptions or quality issues. Diversifying sourcing and establishing contingency plans are vital strategies.
Sources
More… ↓
