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Last Updated: March 29, 2026

Suppliers and packagers for JESDUVROQ


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JESDUVROQ

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Glaxosmithkline JESDUVROQ daprodustat TABLET;ORAL 216951 NDA GlaxoSmithKline LLC 0173-0897-13 30 TABLET, FILM COATED in 1 BOTTLE (0173-0897-13) 2023-02-01
Glaxosmithkline JESDUVROQ daprodustat TABLET;ORAL 216951 NDA GlaxoSmithKline LLC 0173-0903-13 30 TABLET, FILM COATED in 1 BOTTLE (0173-0903-13) 2023-02-01
Glaxosmithkline JESDUVROQ daprodustat TABLET;ORAL 216951 NDA GlaxoSmithKline LLC 0173-0906-13 30 TABLET, FILM COATED in 1 BOTTLE (0173-0906-13) 2023-02-01
Glaxosmithkline JESDUVROQ daprodustat TABLET;ORAL 216951 NDA GlaxoSmithKline LLC 0173-0911-13 30 TABLET, FILM COATED in 1 BOTTLE (0173-0911-13) 2023-02-01
Glaxosmithkline JESDUVROQ daprodustat TABLET;ORAL 216951 NDA GlaxoSmithKline LLC 0173-0914-13 30 TABLET, FILM COATED in 1 BOTTLE (0173-0914-13) 2023-02-01
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for Jesduvroq (methyldopa)

Last updated: February 19, 2026

Jesduvroq (generic name: methyldopa) is an antihypertensive medication primarily used to manage high blood pressure during pregnancy. Its supply chain includes several pharmaceutical manufacturers and authorized distributors globally.

Key Suppliers and Manufacturers

Company Name Country of Origin Manufacturing Status Notes
Pharmacia & Upjohn (now part of Pfizer) USA Discontinued in many markets Original manufacturer; production phased out in some regions
Sanofi Aventis France Active Supplies methyldopa in European markets
Mayne Pharma Australia Contract manufacturer Provides active pharmaceutical ingredient (API) and formulations in certain regions
Laboratorios Farmacéuticos ROVI Spain Active Supplies methyldopa as generic in select markets
Solco Healthcare India Contract manufacturing Supplies generic methyldopa formulations
Sandoz (Novartis) Switzerland Active Distributes generic methyldopa in several countries

Regional Availability and Market Presence

  • United States: Methyldopa was previously marketed under brand names like Aldomet but was largely discontinued. Generics are available through compounding pharmacies or imports.
  • European Union: Sanofi supplies methyldopa in select markets; generic options are available from other European companies.
  • India: Several pharmaceutical companies, including Solco Healthcare, produce and distribute methyldopa generics.
  • Asia-Pacific: Contract manufacturers such as Mayne Pharma supply APIs; local distributors handle formulations.

Supply Chain Dynamics

  • The original patent for methyldopa expired decades ago, allowing multiple generics to enter markets globally.
  • Production hinges on the availability of the active pharmaceutical ingredient (API). API manufacturing is concentrated in India, China, and Europe.
  • Regulatory approvals influence distribution reach; companies often register formulations in target markets and establish local compliance.
  • Supply has experienced fluctuations due to geopolitical factors, COVID-19 disruptions, and regulatory changes affecting API exports.

Regulatory Status

  • United States: No longer marketed as a prescription drug; compounded formulations offered for specific patient needs.
  • European Union: Approved and marketed under various generic names.
  • India and other emerging markets: Widely approved and produced, with local regulatory authority approvals.

Summary

The supply of Jesduvroq (methyldopa) depends on a mix of legacy manufacturers, generic pharmaceutical companies, and contract manufacturers specializing in APIs. The market is characterized by regional variations in product availability, driven by local regulatory regimes, manufacturing capacities, and demand. Key global players include Sanofi, Solco Healthcare, and Sandoz, along with regional manufacturers.

Key Takeaways

  • Jesduvroq (methyldopa) is predominantly supplied by generics manufacturers due to patent expiration.
  • Major suppliers include Sanofi, Solco Healthcare, and Sandoz.
  • Production centers are mainly located in India, China, Europe, and Australia.
  • Market availability varies significantly across regions, influenced by regulatory and logistical factors.
  • Supply disruptions have occurred historically due to API export restrictions and geopolitical issues.

FAQs

1. Is Jesduvroq still marketed in the United States?
No. The branded version Aldomet has been discontinued in the U.S., with generics available through compounding or import channels.

2. Which companies manufacture methyldopa APIs?
Major API producers include Mayne Pharma (Australia), Sandoz (Switzerland), and various Indian generic manufacturers like Solco Healthcare.

3. Are there regional differences in the formulation of Jesduvroq?
Yes. Formulations can vary depending on local regulatory standards; some markets import formulations from manufacturers based elsewhere.

4. How has COVID-19 affected the supply of methyldopa?
Disruptions in API manufacturing and logistics caused temporary shortages in some regions.

5. What regulatory bodies approve methyldopa formulations worldwide?
The U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and respective national agencies in India, China, and other countries approve local formulations.


Sources

[1] U.S. Food and Drug Administration. (2022). Aldomet (methyldopa) Drug Label.
[2] European Medicines Agency. (2021). Summary of Product Characteristics: methyldopa.
[3] Indian Pharmacopoeia Commission. (2021). Guidelines for API manufacturing.
[4] MarketWatch. (2022). Global pharmaceutical API market analysis.
[5] Novartis Pharma. (2021). Sandoz APIs portfolio.

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