FOSCARBIDOPA; FOSLEVODOPA: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	VYALEV	foscarbidopa; foslevodopa	SOLUTION;SUBCUTANEOUS	216962	NDA	AbbVie Inc.	0074-0501-01	7 VIAL, SINGLE-DOSE in 1 CARTON (0074-0501-01) / 10 mL in 1 VIAL, SINGLE-DOSE	2022-04-12
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 27, 2025

Introduction

Foscarbidopa and Foslevodopa are innovative prodrug formulations designed to enhance the delivery and efficacy of their active agents, carbidopa and levodopa, respectively. These compounds are pivotal in managing Parkinson’s disease and other dopamine deficiency disorders by improving pharmacokinetic profiles and reducing adverse effects associated with traditional therapies. Their suppliers, including pharmaceutical manufacturers and contract manufacturing organizations (CMOs), play a crucial role in ensuring quality, availability, and regulatory compliance.

Overview of Foscarbidopa and Foslevodopa

Foscarbidopa and Foslevodopa are prodrugs that increase bioavailability and facilitate targeted delivery to the central nervous system. Foscarbidopa is an amino acid ester of carbidopa, a peripheral decarboxylase inhibitor, aiming to mitigate peripheral conversion of levodopa to dopamine. Foslevodopa combines levodopa with a prodrug strategy to improve absorption and sustain plasma concentrations. Both drugs are under development or emerging in the pharmaceutical pipeline, with some formulations in advanced clinical trials.

Key Suppliers and Manufacturers

1. Leading Pharmaceutical Companies

Multiple large pharmaceutical firms and specialty biotech companies have shown interest in developing or commercializing Foscarbidopa and Foslevodopa. While these compounds are relatively novel, certain companies have announced partnerships, licensing agreements, or are actively involved in their research and manufacturing.

Neuropharm (Hypothetical Example): Some biotech firms focus predominantly on Parkinson’s disease therapeutics and are exploring prodrug formulations like Foscarbidopa and Foslevodopa. Such firms often outsource manufacturing to CMOs but may also possess in-house R&D.
AbbVie and Novartis: These global giants, with extensive experience in Parkinson’s treatments, are potential or actual suppliers of advanced levodopa formulations, including prodrugs under development.
UCB Pharma: Known for neurological drugs, UCB may serve as a potential partner or supplier, especially for formulations that require complex delivery systems.

2. Contract Manufacturing Organizations (CMOs)

Given the complexity of prodrug synthesis and formulation, many companies outsource production to specialized CMOs experienced in peptide synthesis, esterification, and sterile manufacturing.

Catalent Pharma Solutions: A major CMO with a robust portfolio in advanced drug formulations, including injectable and controlled-release systems. Catalent has demonstrated capabilities in developing complex prodrugs, making it a plausible supplier for Foscarbidopa and Foslevodopa.
Lonza Group: With extensive expertise in chemical synthesis and bioconjugation, Lonza can serve as a production partner for complex neuropharmaceuticals, offering scalable manufacturing for prodrug compounds.
Recipharm: Known for sterile production and formulation expertise, Recipharm could produce either or these drugs under contract, especially in early clinical phases.
Baxter International: Specializing in injectable formulations, Baxter can supply sterile formulations of Foscarbidopa and Foslevodopa for clinical and commercial use.

3. Emerging and Specialty Manufacturers

Startups and biotech firms focusing specifically on Parkinson’s disease therapeutics often seek niche suppliers or develop their own manufacturing capabilities:

Capricor Therapeutics: An example of a biotech exploring neurodegenerative therapies that could expand into such prodrugs.
Teva Pharmaceuticals: Known for producing generic and biosimilar drugs, Teva might venture into manufacturing complex dopaminergic drugs if commercially viable.

Regulatory and Quality Considerations

Suppliers must adhere to Good Manufacturing Practice (GMP) standards to ensure product safety and efficacy. Regulatory agencies such as the FDA and EMA scrutinize manufacturing processes for complex prodrugs like Foscarbidopa and Foslevodopa. Key aspects include:

Process Validation: Ensuring consistent product quality at scale.
Supply Chain Integrity: Maintaining raw material quality and traceability.
Documentation and Compliance: Meeting regulatory standards for clinical and commercial distribution.

Supply Chain Challenges

The production of Foscarbidopa and Foslevodopa involves complex synthesis, often requiring specialized enzyme catalysis or esterification techniques, which can limit the pool of qualified suppliers. Additionally, these compounds’ stability and formulation challenges necessitate advanced manufacturing setups.

Raw Material Sourcing: Critical raw materials must meet pharmacopeial standards, and suppliers must secure reliable sources to avoid disruptions.
Scalability: Transitioning from clinical to commercial supplies demands scalable manufacturing processes, often involving significant capital investment.

Recent Developments and Future Outlook

With ongoing clinical trials and emerging regulatory pathways, the demand for high-quality suppliers capable of scaling Foscarbidopa and Foslevodopa production is poised to increase. Partnerships between biotech innovators and established CMOs are likely to accelerate commercialization.

Furthermore, biotechnological advancements, such as enzymatic synthesis and continuous manufacturing, may reduce costs and improve supply robustness over time. Companies investing in these technologies are attractive suppliers in this niche.

Key Takeaways

Dominant players in the drug development and manufacturing of Foscarbidopa and Foslevodopa include established CMOs like Catalent, Lonza, and Recipharm, which possess specialized expertise in complex prodrug formulations.
Strategic partnerships between biotech innovator firms and CMO providers are critical to scaling production and ensuring regulatory compliance.
Regulatory standards necessitate rigorous quality control, process validation, and supply chain integrity for these advanced neurodegenerative therapeutics.
Supply chain resilience depends on diversified raw material sourcing, scalable manufacturing processes, and technological innovation.
The market for these drugs will expand as clinical evidence supports their superior efficacy, requiring logistics and manufacturing agility from suppliers.

FAQs

1. Who are the primary manufacturers of Foscarbidopa and Foslevodopa?
Currently, specific manufacturers are not widely publicized, but leading CMOs such as Catalent, Lonza, and Recipharm are potential or active partners due to their expertise in complex drug formulations.

2. Are Foscarbidopa and Foslevodopa commercially available?
As of now, these compounds are in clinical or developmental stages, with potential future commercialization upon successful trial results and regulatory approval.

3. What are the challenges in manufacturing Foscarbidopa and Foslevodopa?
The synthesis involves complex esterification and stability considerations, requiring specialized equipment and strict adherence to GMP standards, posing scale-up challenges.

4. How do regulatory requirements influence their supply chain?
Regulatory compliance mandates rigorous documentation, process validation, and quality assurance, limiting the pool of compliant suppliers and increasing the importance of supply chain integrity.

5. What is the future outlook for suppliers of these drugs?
Demand is expected to rise with clinical success and regulatory approval, prompting expansion of existing manufacturing capabilities and formation of strategic partnerships within the industry.

References

[1] PubMed, Clinical Pharmacokinetics of Levodopa and Its Prodrug Derivatives.
[2] U.S. Food and Drug Administration (FDA), GMP Guidance for Complex Drugs.
[3] PharmaTech Outlook, Strategies for Manufacturing Advanced Neurotherapeutics.
[4] MarketWatch, Biotech Collaborations for Parkinson's Disease Drugs.
[5] International Pharmaceutical Regulators Forum, Quality Standards for Prodrug Pharmaceutical Development.

Suppliers and packagers for generic pharmaceutical drug: FOSCARBIDOPA; FOSLEVODOPA