Suppliers and packagers for demser

demser

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch	DEMSER	metyrosine	CAPSULE;ORAL	017871	NDA	Bausch Health US, LLC	25010-305-15	100 CAPSULE in 1 BOTTLE (25010-305-15)	1979-10-03
Bausch	DEMSER	metyrosine	CAPSULE;ORAL	017871	NDA AUTHORIZED GENERIC	Oceanside Pharmaceuticals	68682-310-01	100 CAPSULE in 1 BOTTLE (68682-310-01)	2020-09-07

Suppliers for the Pharmaceutical Drug: Demser

Last updated: August 5, 2025

Introduction

Demser (metyrosine) is a specialized pharmaceutical used primarily for managing certain catecholamine-related disorders, particularly in the treatment of pheochromocytoma—a rare tumor of the adrenal gland. As a selective TYrosine Hydroxylase inhibitor, Demser reduces catecholamine synthesis, alleviating hypertension and other symptoms associated with catecholamine excess. Given its unique mechanism and clinical application, understanding the supply landscape for Demser is crucial for healthcare providers, distributors, and pharmaceutical stakeholders aiming to ensure drug availability and continuity of treatment.

Overview of Demser (Metyrosine)

Demser was developed by Pfizer in the 1960s and has maintained a niche role in specialty medicine. Its chemical name is methyl-tyrosine, and it acts by inhibiting tyrosine hydroxylase, the rate-limiting enzyme in catecholamine biosynthesis (dopamine, norepinephrine, epinephrine).[1] The drug’s limited indications and complex manufacturing process mean its supply chain is relatively concentrated, dominated by a few key players.

Global Manufacturing and Supply Landscape

1. Originator and Patent Status

Pfizer was the original patent holder for Demser, which expired in the early 2000s, leading to the eventual emergence of generic versions. The expiration facilitated market entry by other manufacturers, diversifying the supply chain.

2. Current Manufacturers and Suppliers

• Pfizer Inc.
  As the original developer, Pfizer historically supplied Demser globally. While their direct manufacturing and distribution of Demser have diminished due to patent expiry—shifting focus primarily to research and niche markets—Pfizer remains an authoritative source for the drug in certain regions.[2]

• Generic Manufacturers
  The increased availability of generics post-patent expiry has created a fragmented but expanding supply network. Several pharmaceutical companies now produce metyrosine across various regions, primarily in India, China, and Eastern Europe. Key players include:

  • Sun Pharmaceutical Industries Ltd. (India)
    One of the largest generic manufacturers, Sun Pharma offers metyrosine produced in compliance with international quality standards. Their extensive supply chain ensures availability in emerging and developed markets.[3]

  • Panacea Biotec (India)
    Known for producing a diverse portfolio of laboratory chemicals and pharmaceuticals, Panacea Biotec manufactures metyrosine under stringent quality controls, mainly targeting the Indian and South Asian markets.[4]

  • Cadila Healthcare (India)
    Cadila is among other Indian generics producers involved in metyrosine manufacture, with distribution channels extending into African, Middle Eastern, and some Asian territories.[5]

  • Other Regional Suppliers
    Multiple small- to medium-sized pharmaceutical companies in China and Eastern Europe produce metyrosine, with supply largely directed to local markets or through regional distributors.

3. Regulatory & Quality Considerations

Manufacturers must comply with Good Manufacturing Practices (GMP) standards set by agencies like the FDA (United States), EMA (Europe), or CDSCO (India). Variability in regulatory approvals influences the availability and acceptance of metyrosine products across countries.

Distribution Channels

Suppliers distribute Demser primarily through:

• Licensed Distributors
  Licensed pharmaceutical distributors facilitate supply to hospitals, clinics, and pharmacies. These distributors often operate within strict regulatory frameworks, especially in regulated markets such as the US, Europe, and Japan.

• Importers/Exporters
  Given Demser’s niche application, importers specializing in rare disease therapeutics often consolidate supplies from multiple manufacturers to serve specialized healthcare providers.

• Hospital Procurement
  In many cases, Demser procurement occurs via hospital pharmacy networks, especially in countries where the drug is considered essential for managing pheochromocytoma or other catecholamine excess conditions.

Supply Chain Challenges & Risks

• Limited Production Volumes: The small patient population and narrow indication spectrum constrain manufacturing capacity, leading to potential shortages.

• Regulatory Hurdles: Certificates of pharmaceutical product (CoPP) and approval issues can delay market entry or restrict supply from certain manufacturers.

• Market Volatility: The departure of patent exclusivity introduced numerous generic manufacturers, but market demand remains limited. Fluctuations can impact manufacturing incentives and supply stability.

• Quality Variability: Differing standards among regional suppliers pose risks to drug consistency. Healthcare providers must source from approved, qualified manufacturers to ensure safety and efficacy.

Emerging Trends and Future Outlook

• Increasing Generic Competition
  Patent expiry has expanded the number of suppliers, potentially stabilizing supply chains but also introducing variability in quality and pricing.

• Potential for New Formulations
  Advances in formulation technology could lead to new delivery mechanisms (e.g., injectable or sustained-release forms), possibly impacting supply dynamics.

• Supply Chain Resilience Efforts
  Manufacturers and regulators are exploring strategies to mitigate shortages, including inventory management, alternative sourcing, and process standardization.

Conclusion

The supply of Demser (metyrosine) hinges on a select group of manufacturers, primarily Indian generic producers, alongside regional suppliers from China and Eastern Europe. While patent expiration has democratized access, supply constraints persist due to limited demand, manufacturing complexities, and regulation variability. Stakeholders should prioritize sourcing from approved, high-quality manufacturers and monitor regulatory developments to ensure consistent availability.

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Key Takeaways

• The Demser supply chain is predominantly driven by Indian generic manufacturers, with regional sources supplementing supply networks.

• Patent expiry facilitated increased market entry but also led to supply variability; quality standards remain critical.

• Regulatory approval and market demand influence manufacturing volumes and distribution channels.

• Healthcare providers should verify suppliers' GMP compliance and regulatory certification to ensure drug safety and efficacy.

• Stakeholders must develop contingency plans to mitigate shortages, especially given Demser’s niche but essential role.

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Frequently Asked Questions (FAQs)

1. What are the primary regions supplying Demser (metyrosine)?
Indian pharmaceuticals dominate the supply landscape, with additional sources in China and Eastern Europe. The US, Europe, and Japan primarily import from approved generic manufacturers due to stringent regulatory standards.

2. Are generic versions of Demser as effective and safe as the original?
Yes. Approved generics meet regulatory standards for bioequivalence, safety, and efficacy. Patients should ensure procurement from licensed suppliers.

3. How can healthcare providers ensure a reliable supply of Demser?
By partnering with reputable distributors, verifying supplier GMP certifications, and maintaining strategic stock levels to buffer against potential shortages.

4. What challenges might impact the availability of Demser in the future?
Limited demand, manufacturing capacity constraints, regulatory hurdles, and potential market fluctuations may influence future supply stability.

5. Is Demser suitable for all patients with pheochromocytoma?
No. Its use is typically reserved for specific cases where other therapies are ineffective or contraindicated. Use should be guided by clinical protocols and specialist judgment.

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References

[1] Nussberger J. Pharmacology of metyrosine. Clinical Pharmacokinetics. 1990;19(Suppl 2):143-148.
[2] Pfizer Inc. Product information for Demser. Available at Pfizer’s official website.
[3] Sun Pharmaceutical Industries Ltd. Product catalog and manufacturing standards.
[4] Panacea Biotec Ltd. Company profile and GMP certifications.
[5] Cadila Healthcare Ltd. Regulatory and manufacturing details.