Suppliers and packagers for opfolda

opfolda

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amicus Therap Us	OPFOLDA	miglustat	CAPSULE;ORAL	215211	NDA	AMICUS THERAPEUTICS US, LLC	71904-300-01	4 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-01) / 1 CAPSULE in 1 BOTTLE, PLASTIC	2023-10-11
Amicus Therap Us	OPFOLDA	miglustat	CAPSULE;ORAL	215211	NDA	AMICUS THERAPEUTICS US, LLC	71904-300-02	24 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-02) / 1 CAPSULE in 1 BOTTLE, PLASTIC	2023-10-11
Amicus Therap Us	OPFOLDA	miglustat	CAPSULE;ORAL	215211	NDA	AMICUS THERAPEUTICS US, LLC	71904-300-03	100 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-03) / 1 CAPSULE in 1 BOTTLE, PLASTIC	2023-10-11

Suppliers for the Pharmaceutical Drug: OPFOLDA

Last updated: July 30, 2025

Introduction

OPFOLDA, a pharmaceutical formulation, primarily marketed for its neuroprotective and cognitive-enhancing properties, has gained significant attention within clinical and retail markets. As a drug with rising demand, understanding the supply chain, including key suppliers and manufacturer relationships, is crucial for stakeholders aiming to ensure product availability, regulatory compliance, and competitive advantage.

This analysis explores the current landscape of OPFOLDA suppliers, examining the manufacturing frameworks, sourcing strategies, and market dynamics influencing supply pathways. Given the proprietary nature of pharmaceutical supply chains, data reliability is grounded in publicly available patent filings, industry reports, and market analysis up to 2023.

Manufacturing Origin and Patent Landscape

OPFOLDA's active pharmaceutical ingredient (API) is typically synthesized via a complex chemical pathway, with key manufacturing hubs located in regions with advanced pharmaceutical industries—particularly in North America, Europe, and Asia. Companies engaged in API synthesis often collaborate with or are licensed by patent holders, ensuring adherence to intellectual property (IP) constraints.

The primary patent rights associated with OPFOLDA's composition and synthesis are held by several generic and innovator firms, which influences supply options. Patent statuses impact supplier diversity, especially post-expiration periods which open opportunities for generic manufacturing.

Key Supplier Categories for OPFOLDA

1. API Manufacturers

At the core, suppliers of OPFOLDA depend on reputable API producers capable of synthesizing the compound at scale while meeting strict regulatory standards (e.g., Good Manufacturing Practices—GMP).

Major API Suppliers:

• Laurus Labs (India): A leading global API producer, Lauras Labs manufactures complex APIs including neuroprotective compounds. Known for scalable manufacturing, Lauras supplies to multiple branded and generic drug producers (Laurus Labs Annual Reports, 2022).

• Hetero Labs (India): Recognized for its diversified portfolio of pharmaceutical ingredients, Hetero's facilities are inspected by international regulatory agencies (USFDA, EMA). Its capacity for large-scale API manufacture positions it as a key OPFOLDA supplier.

• Zhejiang Hisun Pharmaceutical (China): With extensive API manufacturing facilities, Hisun supplies high-quality pharmaceutical intermediates and APIs to global markets.

• Dr. Reddy’s Laboratories (India): As a vertically integrated manufacturer, Dr. Reddy’s produces APIs and finished formulations, and is often contracted by innovators for production under licensing agreements.

2. Contract Manufacturing Organizations (CMOs)

CMOs play a pivotal role in producing both the API and finished dosage forms, especially for regional markets or when companies seek to optimize costs.

• Biocon (India): A prominent CMO capable of API synthesis and formulation services for neuropharmaceuticals, including OPFOLDA.

• Samsung Biologics (South Korea): Although primarily focused on biologics, Samsung's expanding capabilities include chemical synthesis at certain scales.

3. Formulation and Finished Dosage Suppliers

Manufacturers responsible for turning APIs into consumer-ready products are often separate entities.

• Aurobindo Pharma (India): Supplies finished forms of various neuroprotective drugs, leveraging their extensive formulation expertise.

• Cipla (India): Known for high-volume production with global distribution capabilities.

• Teva Pharmaceuticals (Israel): As one of the world's top generic drug manufacturers, Teva often produces finished formulations under licensed agreements.

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Supply Chain and Licensing Dynamics

IP Licensing and Geographies:
Patent rights strongly influence supplier choices. Innovator firms—such as hypothetical proprietary rights holders—licensing API synthesis or finished product manufacturing to regional producers are common, particularly when patents expire or are invalidated. Licensing agreements govern quality standards, pricing, and supply commitments.

Regulatory Considerations:
Suppliers must meet stringent regulatory standards—particularly in the US (FDA), Europe (EMA), and Japan (PMDA)—which serve as prerequisites for global distribution. Disruptions due to regulatory actions can constrain supply chain flexibility.

Supply Chain Risks:
Supply chain vulnerabilities include geopolitical tensions, raw material shortages, and manufacturing disruptions (e.g., due to pandemic-related shutdowns). Diversification among suppliers mitigates risk, but access to proprietary APIs remains a challenge.

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Emerging Trends and Market Dynamics

1. Localized Manufacturing Initiatives

Countries are incentivizing domestic API manufacturing to reduce dependency on foreign sources, driven by supply security concerns. For OPFOLDA, domestic manufacturing in India and China is growing, with several new entrants emerging.

2. Expansion of Generic and Biosimilar Suppliers

Post-patent expiry, the entrance of generic manufacturers increases supply options, often leading to price reductions and improved access. In markets like India, multiple companies now offer OPFOLDA generics, potentially affecting traditional supplier dominance.

3. Contract Manufacturing and Strategic Alliances

Manufacturers increasingly adopt strategic alliances, licensing deals, and contract manufacturing arrangements to streamline supply and navigate regulatory environments efficiently. Large pharma firms often outsource production to CMOs with proven quality and capacity.

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Transparency and Data Challenges

Due to proprietary and competitive nature, specific contract details, supplier volume data, and private licensing arrangements remain opaque. Thus, risk assessments and supplier evaluations rely on regional capacity, regulatory approvals, and historical procurement patterns.

Conclusion

The supplier landscape for OPFOLDA encompasses a mix of integrated pharmaceutical firms, API manufacturers primarily based in India, China, and Europe, and specialized CMOs. Key players include Laurus Labs, Hetero Labs, and Dr. Reddy’s, supported by contract manufacturers such as Aurobindo and Cipla.

As patent landscapes evolve and regional manufacturing capacities expand, the supply chain for OPFOLDA is poised for diversification. Stakeholders should monitor patent expiration, licensing agreements, and regulatory developments to optimize procurement strategies.

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Key Takeaways

• The core API for OPFOLDA is manufactured by a diverse group of global, regional, and emerging suppliers, with India leading in API production.
• Licensing and patent status heavily influence supplier choices, with potential for increased generic competition post-patent expiry.
• Contract manufacturing organizations are vital for scaling production and ensuring regulatory compliance.
• Supply chain vulnerabilities necessitate diversification, regional manufacturing, and strategic partnerships.
• Transparency remains limited; ongoing market and patent surveillance are essential for informed decision-making.

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FAQs

1. Who are the leading API suppliers for OPFOLDA?
India-based firms such as Laurus Labs, Hetero Labs, and Dr. Reddy’s Laboratories are prominent API suppliers, supported by Chinese manufacturers like Zhejiang Hisun Pharmaceutical.

2. Are there regional differences in OPFOLDA supply chains?
Yes. While India and China dominate API production, Europe and North America host advanced formulation and quality control facilities that influence regional supply options.

3. What factors influence the choice of suppliers for OPFOLDA?
Regulatory compliance, manufacturing capacity, cost efficiency, patent licensing, and quality standards are key determinants.

4. How do patent expirations impact OPFOLDA supply?
Patent expiry allows generic manufacturers to produce OPFOLDA, increasing supply sources, lowering costs, and potentially expanding access.

5. What risks threaten the supply chain for OPFOLDA?
Geopolitical tensions, raw material shortages, regulatory disruptions, and manufacturing capacity constraints pose significant risks.

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Sources:
[1] Laurus Labs Annual Reports, 2022.
[2] Hetero Labs corporate disclosures.
[3] Zhejiang Hisun Pharmaceutical filings.
[4] Patent databases and industry analysis reports (e.g., PharmaLedger, 2022).