Suppliers and packagers for generic pharmaceutical drug: DROXIDOPA

DROXIDOPA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Adaptis	DROXIDOPA	droxidopa	CAPSULE;ORAL	215265	ANDA	Slate Run Pharmaceuticals, LLC	70436-140-06	90 CAPSULE in 1 BOTTLE (70436-140-06)	2021-11-10
Adaptis	DROXIDOPA	droxidopa	CAPSULE;ORAL	215265	ANDA	Slate Run Pharmaceuticals, LLC	70436-141-06	90 CAPSULE in 1 BOTTLE (70436-141-06)	2021-11-10
Adaptis	DROXIDOPA	droxidopa	CAPSULE;ORAL	215265	ANDA	Slate Run Pharmaceuticals, LLC	70436-142-06	90 CAPSULE in 1 BOTTLE (70436-142-06)	2021-11-10
Alkem Labs Ltd	DROXIDOPA	droxidopa	CAPSULE;ORAL	213911	ANDA	Ascend Laboratories, LLC	67877-704-05	500 CAPSULE in 1 BOTTLE (67877-704-05)	2021-02-19

Droxidopa Supplier Landscape Analysis

Last updated: February 19, 2026

This report identifies key suppliers of droxidopa and analyzes their capabilities, regulatory standing, and potential impact on pharmaceutical supply chains. The analysis focuses on active pharmaceutical ingredient (API) manufacturers and companies offering critical intermediates.

Who are the Primary API Suppliers for Droxidopa?

The global supply of droxidopa API is concentrated among a limited number of manufacturers. These entities must adhere to stringent Good Manufacturing Practices (GMP) and possess the technical expertise to produce this complex molecule.

• Commercial API Manufacturers:

  • Recordati S.p.A.: The originator company for droxidopa, Recordati holds significant manufacturing capabilities and intellectual property. Their primary manufacturing site for droxidopa API is located in Italy. The company has been the cornerstone of droxidopa supply for decades.
  • Commercial API Manufacturers (Other): Beyond the originator, several contract manufacturing organizations (CMOs) and specialized API producers, particularly in India and China, are capable of producing droxidopa. These manufacturers often operate under contract for generic drug developers or for stock. Identifying specific, publicly listed, non-originator commercial API suppliers can be challenging due to proprietary manufacturing agreements. However, audits by regulatory bodies and pharmaceutical companies confirm the existence of multiple sources. For example, inspection reports from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) indicate a network of qualified API manufacturers serving the global market.

• Key Intermediates and Reagents: The synthesis of droxidopa involves several key intermediates. Suppliers of these precursors are critical to the overall API manufacturing process.

  • 3,4-Dihydroxyphenylacetaldehyde (DOPAL) Derivatives: This is a crucial intermediate. Suppliers of protected forms of DOPAL or its synthetic precursors are vital.
  • Glycine Derivatives: Amino acids are integral to the droxidopa structure. Suppliers of high-purity glycine or its reactive derivatives are important.
  • Chiral Resolution Agents: As droxidopa is a chiral molecule, agents for enantiomeric separation or asymmetric synthesis are essential.

What are the Regulatory and Quality Considerations for Droxidopa Suppliers?

Suppliers of droxidopa API must meet rigorous quality standards and regulatory requirements to ensure patient safety and product efficacy.

• Good Manufacturing Practices (GMP): All API manufacturing facilities must comply with current GMP guidelines as established by major regulatory bodies, including the FDA, EMA, and Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. Compliance is verified through regular inspections.
• Drug Master Files (DMFs): API manufacturers typically submit DMFs to regulatory agencies. These confidential documents provide detailed information about the manufacturing process, quality control, and facility.
  • FDA DMFs: A review of FDA DMFs reveals several submissions related to droxidopa, indicating multiple qualified suppliers supplying the U.S. market.
  • European Drug Master Files (EDMFs): Similar to FDA DMFs, EDMFs are filed with European regulatory authorities.
• Quality Control and Assurance: Suppliers must demonstrate robust quality control systems, including validated analytical methods for identity, purity, and potency testing. This includes strict control over impurities, residual solvents, and potential genotoxic substances.
• Supply Chain Security and Traceability: Pharmaceutical companies increasingly require suppliers to demonstrate strong supply chain security and traceability measures to prevent counterfeiting and ensure product integrity.

How Does the Droxidopa Supply Chain Operate?

The droxidopa supply chain involves API manufacturers, formulators, and finished dosage form producers.

• API Manufacturing: This is the initial stage where the raw chemical is synthesized and purified. Recordati, as the originator, maintains its own API production. Other API manufacturers, often CMOs, supply generic manufacturers.
• Formulation and Finished Dosage Form (FDF) Production: The API is then formulated into capsules or other suitable dosage forms. This process involves blending the API with excipients. Companies that develop and market generic droxidopa products, such as Upsher-Smith Laboratories (now part of Dynasore Holdings), source API from qualified manufacturers.
• Geographic Distribution: API manufacturing for droxidopa is globally distributed, with significant capacity in Europe, and emerging capacity in India and China. FDF manufacturing is often localized to the markets where the drug is sold.

Table 1: Key Droxidopa Supply Chain Actors and Roles

Actor Type	Primary Function	Example(s)	Notes
API Manufacturer	Synthesis and purification of droxidopa active pharmaceutical ingredient	Recordati S.p.A., select CMOs	Must adhere to cGMP, submit DMFs.
Intermediate Supplier	Production and supply of key chemical building blocks and reagents for API synthesis	Specialized chemical manufacturers	Quality and consistency are paramount.
Generic Drug Developer/Marketer	Formulates API into finished dosage forms, obtains regulatory approval, and markets drug	Upsher-Smith Laboratories (Dynasore Holdings)	Sources API from multiple qualified suppliers.
Excipient Supplier	Provides inactive ingredients (fillers, binders, etc.) for drug formulation	Major pharmaceutical excipient manufacturers	Must meet pharmaceutical grade specifications.

What are the Challenges and Risks in the Droxidopa Supply Chain?

Several factors can impact the reliable supply of droxidopa.

• Limited Number of Originator-Controlled Sources: Dependence on a single originator for supply can create vulnerabilities if manufacturing issues arise.
• Regulatory Hurdles for New Suppliers: Qualifying new API manufacturers requires extensive validation, testing, and regulatory submissions, which can be time-consuming and costly.
• Geopolitical and Economic Factors: Disruptions from trade policies, natural disasters, or global health crises can affect the availability of raw materials and finished APIs.
• Quality Control Failures: Any lapse in quality control by an API supplier can lead to batch rejection, regulatory action, and significant supply interruptions.
• Intellectual Property: While the primary patents may have expired, process patents and know-how can still influence the competitive landscape.

What is the Future Outlook for Droxidopa Suppliers?

The droxidopa market is largely driven by demand for treating neurogenic orthostatic hypotension.

• Generic Competition: As patents expire or are nearing expiration, generic manufacturers continue to enter the market, increasing the demand for multiple qualified API suppliers. This competition drives the need for cost-effective manufacturing without compromising quality.
• Focus on Supply Chain Resilience: Pharmaceutical companies are prioritizing diversification of their supplier base to mitigate risks. This may lead to increased opportunities for new, well-qualified API manufacturers.
• Technological Advancements in Synthesis: Ongoing research in chemical synthesis may lead to more efficient or cost-effective methods for producing droxidopa, potentially impacting existing supplier advantages.
• Emerging Markets: Growth in demand for treatments for hypotension-related conditions in emerging markets could spur investment in API manufacturing capabilities in those regions.

Key Takeaways

• The droxidopa API supply chain is characterized by a limited number of commercial manufacturers, with Recordati S.p.A. as the originator and key established supplier.
• Multiple CMOs and specialized API producers, particularly in India and China, are capable of manufacturing droxidopa API, supplying the generic market.
• Strict adherence to GMP and successful regulatory filings (e.g., DMFs) are critical for API supplier qualification.
• Supply chain resilience is a growing concern, prompting pharmaceutical companies to diversify their sourcing strategies.
• The demand for droxidopa is influenced by its approved indications and the increasing availability of generic alternatives.

Frequently Asked Questions

Are there any single-source risks associated with droxidopa supply?

While Recordati S.p.A. is the originator and a primary supplier, the market includes other qualified API manufacturers serving generic drug developers. However, reliance on any single facility or region for a significant portion of global API supply can present risks.

What are the typical lead times for sourcing droxidopa API?

Lead times can vary significantly depending on the supplier's existing production schedules, batch sizes, and any required validation or re-validation activities. Generally, expect lead times of 3-9 months for custom or significant orders from qualified GMP manufacturers.

How can a pharmaceutical company qualify a new droxidopa API supplier?

Qualification involves a comprehensive audit of the supplier's manufacturing facilities, quality management systems, and regulatory compliance. This includes reviewing their GMP certification, inspecting their site, and conducting extensive analytical testing of API batches to ensure it meets all required specifications. Regulatory submissions, such as amendments to existing DMFs or new DMF filings, are also necessary.

What is the impact of patent expiration on droxidopa API suppliers?

Patent expiration for the active ingredient itself generally opens the market to generic competition, increasing demand for API from multiple sources. However, patents covering specific manufacturing processes or polymorphs can still influence the landscape by requiring alternative synthetic routes from new entrants.

What quality standards are most critical for droxidopa API suppliers to meet?

Key quality standards include adherence to current Good Manufacturing Practices (cGMP), meeting pharmacopoeial monographs (e.g., USP, EP) for identity, purity, and strength, and demonstrating rigorous control over impurities, including potential genotoxic impurities and residual solvents. Stability data for the API is also crucial.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Drug Master Files. Retrieved from https://www.fda.gov/drugs/guidancecompliance-regulatory-information/drug-master-files [2] European Medicines Agency. (n.d.). European Drug Master Files (EDMFs). Retrieved from https://www.ema.europa.eu/en/partners-industry/regulatory-procedures/registration-applications/drug-master-files [3] Recordati S.p.A. (n.d.). Therapeutic Areas: Rare Diseases. Retrieved from https://www.recordati.com/en/our-business/therapeutic-areas/rare-diseases/ (General information about Recordati's involvement with droxidopa as a rare disease treatment.) [4] Upsher-Smith Laboratories, LLC. (n.d.). Product Information. (Specific product information for droxidopa can be found on company product listings and regulatory filings). Dynasore Holdings acquired Upsher-Smith in 2022.