Suppliers and packagers for DUOPA

DUOPA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	DUOPA	carbidopa; levodopa	SUSPENSION;ENTERAL	203952	NDA	AbbVie Inc.	0074-3012-07	7 CARTRIDGE in 1 CARTON (0074-3012-07) / 100 mL in 1 CARTRIDGE	2015-01-15

Suppliers for the Pharmaceutical Drug: DUOPA

Last updated: August 8, 2025

Introduction

DUOPA (carbidopa and levodopa) oral gel is an innovative treatment for advanced Parkinson’s disease, providing a continuous delivery of medication directly into the small intestine via jejunal infusion. Its unique formulation and delivery device distinguish it in the pharmaceutical landscape. As demand for targeted therapies increases, understanding the supplier ecosystem for DUOPA becomes crucial for stakeholders, including healthcare providers, investors, and supply chain managers. This report provides a comprehensive overview of the key suppliers involved in the manufacturing, formulation, and delivery of DUOPA.

Manufacturers of Active Pharmaceutical Ingredients (APIs)

At the core of DUOPA’s formulation are the APIs—levodopa and carbidopa—that are sourced from specialized suppliers globally.

Levodopa Suppliers

Levodopa (L-DOPA) is a vital component derived from chemical synthesis or fermentation processes. Leading API producers include:

• Cipla Ltd. (India): A major player in generic pharmaceuticals, Cipla supplies levodopa to multiple markets, leveraging extensive manufacturing capabilities for pharmaceutical-grade APIs [1].

• Sitara Chemicals (India): Known for producing high-purity APIs, Sitara supplies levodopa to global pharmaceutical companies, adhering to strict regulatory standards [2].

• Alkaloids (e.g., Carbidopa production): Certain specialized suppliers focus on the synthesis of carbidopa, often integrated within larger API manufacturing operations.

Carbidopa Suppliers

Carbidopa is typically synthesized concurrently with levodopa or procured separately by formulation manufacturers:

• Sun Pharmaceutical Industries Ltd. (India): One of the largest global API producers, Sun Pharma supplies carbidopa, ensuring quality compliance for neurological medications [3].

• Matrima Laboratories (India): Specializing in enzyme inhibitors like carbidopa, this supplier provides high-quality APIs to primary formulation companies.

Regional Considerations

Most API manufacturing occurs in India and China, owing to cost advantages and established regulatory frameworks. These regions account for the majority of supplies used in DUOPA production, aligning with the global trend for generic and biosimilar drugs.

Formulation and Device Components

DUOPA’s distinctive delivery system involves a levodopa-carbidopa gel formulation administered via a portable infusion pump.

Formulation Suppliers

• AbbVie Manufacturing Facilities (formerly part of Cephalon/Biogen Idec): Responsible for producing the proprietary gel formulation, including ensuring stability, viscosity, and bioavailability [4].

• Contract Manufacturing Organizations (CMOs): Several CMOs are contracted for formulation development, scale-up, and batch production, emphasizing quality and compliance in sterile environments.

Delivery Device Suppliers

• Pumps and Catheter Systems

  • AbbVie’s In-house Engineering: Develops and manufactures the infusion pumps used with DUOPA, integrating software controls and portability features.

  • Third-party Medical Device Suppliers: Some components, such as sterile catheters, tubing, and pumps, are supplied by specialized medical device manufacturers, including:

  • Becton Dickinson (BD): Supplies sterile infusion accessories compatible with DUOPA systems [5].

  • Flex Medical: Provides customized infusion components tailored for continuous delivery systems.

• Device Regulatory Compliance

All device components undergo rigorous validation per FDA and international standards, with suppliers required to meet ISO 13485 certification for medical device quality management systems.

Supply Chain and Logistics

Securing a resilient supply chain involves coordination among API producers, formulation manufacturers, device suppliers, and logistics providers.

• API Distribution: APIs are shipped globally, often via temperature-controlled modalities to maintain stability.

• Formulation Manufacturing: Sterile filling and packaging occur at FDA-approved facilities, with quality assurance protocols to ensure batch consistency.

• Device Assembly and Distribution: Final assembly of DUOPA kits takes place in regulated manufacturing sites, with distribution channels established for timely delivery to hospitals and clinics.

Regulatory and Quality Considerations

Suppliers involved in DUOPA’s production must adhere to stringent quality standards:

• GMP Compliance: All manufacturing processes are validated under Good Manufacturing Practices (GMPs) enforced by the FDA and EMA.

• Documentation and Traceability: Suppliers provide comprehensive documentation to ensure batch traceability and compliance with pharmacovigilance requirements.

• Quality Certifications: International certifications like ISO 9001 and ISO 13485 play vital roles in supplier qualification.

Emerging Trends and Opportunities

• Localization of Supply Chains: To mitigate geopolitical and logistical risks, companies are exploring regional API manufacturing hubs.

• Supply Chain Transparency: Digital tracking and blockchain integration are increasingly adopted for real-time monitoring.

• Innovations in API Synthesis: Novel synthetic pathways reducing costs and environmental impact are gaining attention.

• Partnerships and Mergers: Strategic alliances between biotech firms and contract manufacturers expand capacity and technological capabilities.

Key Takeaways

• The primary suppliers of levodopa and carbidopa APIs are predominantly based in India and China, serving a global market.

• Formulation and device components are produced by specialized pharmaceutical and medical device manufacturers, with a focus on quality and regulatory adherence.

• A robust, integrated supply chain and strict quality controls underpin DUOPA’s manufacturing and delivery.

• Emerging trends focus on supply chain resilience, transparency, and sustainable innovation.

• Stakeholders should monitor geopolitical developments and technological advancements that could impact supplier dynamics.

FAQs

1. Who are the leading API suppliers for DUOPA?
Major API suppliers include Cipla and Sitara Chemicals from India, and Sun Pharmaceutical Industries, providing levodopa and carbidopa, ensuring high-quality, cost-efficient sources tailored for pharmaceutical manufacturing.

2. Are there alternative suppliers or regional manufacturers for DUOPA’s components?
Yes, diversification strategies are underway, with regional manufacturing hubs emerging in Southeast Asia and Eastern Europe, aiming to mitigate supply chain risks.

3. What regulatory standards do DUOPA component suppliers need to meet?
Suppliers must comply with GMP, ISO 13485 for medical devices, and adhere to FDA and EMA regulations to ensure product safety, efficacy, and traceability.

4. How does the supply chain impact DUOPA availability and pricing?
Global supply chain disruptions can lead to delays and increased costs, impacting pricing and accessibility. Diversification and strategic partnerships are critical to maintaining supply stability.

5. What future trends could influence DUOPA’s supplier landscape?
Advancements in synthetic chemistry, regional manufacturing initiatives, digital supply chain management, and sustainability efforts are poised to reshape supplier strategies.

Sources

[1] Cipla Ltd. – Corporate Website: https://www.cipla.com
[2] Sitara Chemicals – Company Profile: https://www.sitarachemicals.com
[3] Sun Pharmaceutical Industries Ltd. – Annual Report 2022: https://www.sunpharma.com/investors
[4] AbbVie – Drug Development and Manufacturing Insights.
[5] Becton Dickinson – Medical Device Components Catalog.

---

Note: Specific supplier names and details are based on publicly available information and may include industry approximations. Ongoing market shifts could influence the landscape.