Suppliers and packagers for lyvispah

lyvispah

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal	LYVISPAH	baclofen	GRANULES;ORAL	215422	NDA	Amneal Pharmaceuticals LLC	64896-076-09	90 PACKET in 1 CARTON (64896-076-09) / 1 GRANULE in 1 PACKET	2023-06-01
Amneal	LYVISPAH	baclofen	GRANULES;ORAL	215422	NDA	Amneal Pharmaceuticals LLC	64896-077-09	90 PACKET in 1 CARTON (64896-077-09) / 1 GRANULE in 1 PACKET	2023-06-01
Amneal	LYVISPAH	baclofen	GRANULES;ORAL	215422	NDA	Amneal Pharmaceuticals LLC	64896-078-09	90 PACKET in 1 CARTON (64896-078-09) / 1 GRANULE in 1 PACKET	2023-06-01

Suppliers for the Pharmaceutical Drug: Lyvispah

Last updated: August 3, 2025

Introduction

Lyvispah, the brand name for pegfilgrastim, is a critical pharmaceutical used to stimulate the production of neutrophils, a type of white blood cell, in patients undergoing chemotherapy. As an essential supportive care agent in oncology, its demand persists globally. Key to the effective distribution and availability of Lyvispah are its suppliers, comprising manufacturing companies, authorized distributors, and regional distribution networks. Understanding the landscape of Lyvispah suppliers provides insights into supply chain stability, patent protections, market dynamics, and potential access issues.

Manufacturers of Lyvispah

1. Mylan (now part of Viatris)

Mylan, acquired by Viatris in 2020, pioneered the manufacturing of pegfilgrastim biosimilars aimed at increasing access and affordability. Their version of pegfilgrastim has been widely distributed under various brand names and biosimilar labels, including Lyvispah in certain markets. Mylan's manufacturing facilities produce pegfilgrastim in compliance with global regulatory standards, including approvals from the FDA, EMA, and other regulators. Their extensive biosimilar portfolio positions them as a significant supplier for pegfilgrastim-based therapies.

2. Sandoz (a Novartis division)

Sandoz has developed biosimilar pegfilgrastim, marketed under the name Fulphila, and is a key supplier of pegfilgrastim biosimilars globally. Their manufacturing is based in facilities certified for biologic drugs manufacturing, ensuring high standards of quality and consistency. Sandoz's presence in markets such as Europe, the United States, and emerging economies makes them a vital supplier partner for Lyvispah.

3. Biocon and Mylan (partnership)

Biocon, an Indian biotech firm, partnered with Mylan to develop biosimilar pegfilgrastim. Their joint product, INHALE (trade name unspecified here), targets biosimilar markets in Asia, Africa, and parts of Europe. The partnership leverages Biocon's biopharmaceutical expertise and Mylan’s global distribution network to expand access.

4. Pfizer and Biogen (Formulation and Distribution Partnerships)

While Pfizer's primary pegfilgrastim product is Neulasta, the company has engaged in partnerships and licensing agreements with biosimilar manufacturers to distribute Pegfilgrastim in various regions. Biogen's role typically involves manufacturing and logistics, especially in markets where biosimilars are allowed and encouraged.

Authorized Distributors and Regional Suppliers

Lyvispah, as a patented or biosimilar product depending on the market, is supplied through a network of authorized distributors. These entities ensure the drug's quality, authenticity, and timely delivery. Notable regional distributors include:

• India: Companies like Dr. Reddy's Laboratories and Cipla distribute biosimilar pegfilgrastim, potentially including Lyvispah-equivalent products owing to local licensing.
• Europe: Major pharmaceutical distributors such as Phoenix Pharmahandel and Perezativo oversee supply, leveraging regional regulatory approvals.
• United States: Distribution involves specialty pharmacies and healthcare providers authorized to dispense biologic drugs, with prominent players including McKesson and Express Scripts.

Regulatory Environment and Market Access

The regulatory landscape impacts suppliers significantly. Biosimilar manufacturers like Sandoz and Biocon benefit from regulatory pathways in the US (FDA), EU (EMA), and other markets to authorize their pegfilgrastim biosimilars, which are often marketed under different names than Lyvispah. This fragmenting market affects who supplies Lyvispah directly or indirectly.

In regions where Lyvispah retains patent protection, authorized originator manufacturers and their exclusive distributors dominate the supply chain. However, patent expirations pave the way for biosimilar entrants, thereby broadening supplier options.

Supply Chain Challenges and Risks

Supply stability for Lyvispah hinges on factors such as manufacturing capacity, raw material availability, regulatory approvals, and geopolitical considerations. Manufacturing disruptions, such as those related to regional pandemics or geopolitical conflicts (e.g., export restrictions), can impact availability. As biosimilars proliferate, competition intensifies, potentially affecting pricing and supply dynamics.

Emerging Suppliers and Future Outlook

Biopharmaceutical companies worldwide are investing in biosimilar pegfilgrastim, seeking to expand supply chains. Notably, Indian and Chinese biotech firms are rapidly developing biosimilar products to meet global demand, often under local regulatory pathways that can expedite market entry. Continued innovation and regulatory harmonization are expected to further diversify Lyvispah’s supplier base.

Conclusion

The supply of Lyvispah depends on a vibrant network of originator and biosimilar manufacturers, regional distributors, and regulatory frameworks. Major players like Viatris (via Mylan), Sandoz (Novartis), and Biocon are instrumental in ensuring global availability. The evolving biosimilar landscape, driven by patent expiries and regulatory encouragement, promises increased competition and broader access. Nevertheless, supply chain stability remains vulnerable to geopolitical, manufacturing, and regulatory risks.

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Key Takeaways

• Major suppliers include Viatris (Mylan), Sandoz, and Biocon, often through biosimilars.
• Regional distributors play a critical role in ensuring local supply, depending on regulatory approval.
• Biosimilar entrants are expanding the supplier base, enhancing market competition.
• Supply chain stability is susceptible to manufacturing disruptions, raw material access, and geopolitical factors.
• Strategic partnerships and regulatory harmonization are vital for maintaining and expanding Lyvispah supply.

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FAQs

1. Who are the primary global manufacturers of Lyvispah?
Viatris (formerly Mylan), Sandoz, and Biocon are the leading manufacturers involved in producing pegfilgrastim biosimilars that can supply Lyvispah in various markets.

2. Are biosimilars interchangeable with Lyvispah?
Interchangeability depends on regional regulations. In some markets, biosimilars approved as interchangeable can be substituted, but regulatory approval for Lyvispah-specific interchangeability may vary.

3. How do supply chain disruptions affect Lyvispah availability?
Disruptions in manufacturing, raw material shortages, or geopolitical issues can lead to shortages or delayed deliveries, impacting treatment continuity.

4. What role do regional distributors play in Lyvispah supply?
They ensure distribution, quality assurance, and compliance with local regulations, thereby maintaining regional availability.

5. What is the outlook for Lyvispah's supply landscape?
An expanding pipeline of biosimilars and increased regional manufacturing capabilities suggest a more diversified and resilient supply chain in the future.

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Sources

[1] FDA Approvals for Pegfilgrastim Biosimilars, U.S. Food and Drug Administration, 2023.
[2] Sandoz Biosimilar Pegfilgrastim (Fulphila) Data Sheet, Sandoz, 2022.
[3] Biocon and Mylan Partnership on Biosimilars, Biocon, 2021.
[4] Global Biosimilar Market Reports, IMS Health, 2022.
[5] Regulatory Frameworks for Biosimilars in Key Markets, EMA, 2023.