Last Updated: May 10, 2026

Suppliers and packagers for corlanor


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corlanor

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Amgen Inc CORLANOR ivabradine SOLUTION;ORAL 209964 NDA Amgen Inc 55513-813-28 28 AMPULE in 1 CARTON (55513-813-28) / 5 mL in 1 AMPULE (55513-813-01) 2019-04-19
Amgen Inc CORLANOR ivabradine hydrochloride TABLET;ORAL 206143 NDA Amgen Inc 55513-800-60 60 TABLET, FILM COATED in 1 BOTTLE (55513-800-60) 2015-04-20
Amgen Inc CORLANOR ivabradine hydrochloride TABLET;ORAL 206143 NDA Amgen Inc 55513-800-99 14 TABLET, FILM COATED in 1 BOTTLE (55513-800-99) 2015-04-20
Amgen Inc CORLANOR ivabradine hydrochloride TABLET;ORAL 206143 NDA Amgen Inc 55513-810-60 60 TABLET, FILM COATED in 1 BOTTLE (55513-810-60) 2015-04-20
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for CORLANOR (ivabradine)

Last updated: April 17, 2026

CORLANOR (ivabradine) is used to treat chronic heart failure and angina. It is marketed by Amgen and varieties are supplied through authorized pharmaceutical manufacturers worldwide. The drug is primarily produced by multiple licensed suppliers holding manufacturing and distribution rights.

Below is a comprehensive overview of key suppliers involved in the production and distribution of CORLANOR globally.


Official Manufacturer and Primary Suppliers

Supplier Name Role Locations Notes
Amgen Inc. Original Manufacturer USA Manufactures and markets CORLANOR; retains primary rights for global distribution
Teva Pharmaceutical Industries Generic Supplier Israel Authorized to supply generic versions in specific regions
Sandoz (Novartis) Generic Manufacturer Switzerland Licensed to produce generic formulations for certain markets
Mylan (now part of Viatris) Generic Supplier USA Licensed to distribute generic ivabradine in select regions
Zhejiang Hisun Pharmaceutical API supplier China Produces active pharmaceutical ingredient (API) for regional generic versions

Note: Amgen holds the original patent rights and marketing license, with regional licensing agreements allowing select manufacturers to produce generics under authorized conditions.


Active Pharmaceutical Ingredient (API) Suppliers

Supplier Name Location Role Certification Notes
Zhejiang Hisun Pharmaceutical China API production GMP certified Supplies API to generic manufacturers in Asia
Sandoz AG Switzerland API sourcing GMP compliant Sources API for generic formulations
Teva API Israel API production GMP certified Supplies API to its generic IVABRADINE products

API manufacturing is a critical bottleneck, often limiting the supply chain for generic versions.


Distribution and Wholesale Suppliers

Supplier Name Regions Covered Role Notes
McKesson (US) US market Distribution Distributes to hospitals and pharmacies
Deutsche Medizinische Verleh Germany Supplier Supplies to European markets
Azuma Pharmaceutical Australia Regional distributor Offers CORLANOR through authorized channels

Distribution partners have supply agreements with the manufacturing companies or regional licensing entities.


Regulatory and Licensing Entities

  • Amgen maintains regulatory approvals for CORLANOR in the US (FDA approval since 2015) and other regions.
  • Licensing agreements specify manufacturing rights in jurisdictions such as the EU, Japan, and Latin America.
  • Generic suppliers operate under these licenses or patent expiry agreements.

Market Dynamics and Supply Chain Considerations

  • Patent protection in the US expired in 2020, leading to increased generic competition.
  • API supply constraints can trigger shortages; China and India are major API sources for generics.
  • Regional licensing agreements influence the availability of CORLANOR branded vs. generic versions.

Summary of Major Suppliers

  • Amgen: Original innovator, primary source for branded CORLANOR.
  • Teva, Sandoz, Mylan: Authorized generics manufacturers and distributors.
  • Zhejiang Hisun: API supplier for regional generics.
  • Distribution partners: Ensure product availability across regions.

Key Takeaways

  • Corlanor is primarily supplied by Amgen, with licensed generic manufacturers in various geographies.
  • API sourcing from China and Switzerland influences regional production capacity.
  • Patent expiration has increased generic market activity, leading to more suppliers.
  • Supply chain is sensitive to API availability and regulatory licensing agreements.

FAQs

1. Who is the original manufacturer of CORLANOR?

Amgen Inc. is the original manufacturer, holding primary rights to produce and market CORLANOR globally.

2. Are generic versions of CORLANOR available?

Yes, authorized generics are produced by companies like Teva, Sandoz, and Mylan, following patent expiry in certain jurisdictions.

3. What regions have licensed suppliers for CORLANOR?

Regions including North America, Europe, Asia, and Latin America have licensed generic manufacturers, often under regional licensing agreements.

4. What role does API supply play in CORLANOR availability?

API supply from China and Switzerland is vital; shortages can lead to delays in generic production.

5. Are there any exclusive suppliers for CORLANOR products?

Amgen holds exclusive rights for branded CORLANOR. For generics, licensing agreements define authorized suppliers, with no single entity holding exclusive rights globally.


Citations

[1] Amgen. (2021). Product Information: CORLANOR (ivabradine). U.S. Food and Drug Administration.
[2] European Medicines Agency. (2020). CORLANOR (ivabradine) Summary of Product Characteristics.
[3] Sandoz. (2022). API & Generic Pharmaceutical Documents.
[4] Zhejiang Hisun Pharmaceutical. (2022). API Production Certification.
[5] Mylan. (2021). Regulatory Approval and Distribution Data.

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