Suppliers and packagers for generic pharmaceutical drug: BELINOSTAT

BELINOSTAT

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Acrotech Biopharma	BELEODAQ	belinostat	POWDER;INTRAVENOUS	206256	NDA	Acrotech Biopharma Inc	72893-002-01	1 VIAL in 1 CARTON (72893-002-01) / 10 mL in 1 VIAL	2014-07-21

Suppliers for the Pharmaceutical Drug: Belinostat

Last updated: February 19, 2026

Who are the main manufacturers of belinostat?

Belinostat is a histone deacetylase (HDAC) inhibitor approved by the U.S. Food and Drug Administration (FDA) for the treatment of peripheral T-cell lymphoma (PTCL). Its production involves specialized chemical synthesis, quality controls, and regulatory approvals. The primary suppliers involved in its manufacturing and distribution include:

1. Spectrum Pharmaceuticals

• Role: Original developer and commercial supplier under the brand name Beleodaq.
• Market: United States, select international markets.
• Production: Manufactures belinostat through licensing agreements with contract manufacturing organizations (CMOs).
• Status: Provides the drug through proprietary distribution channels; ongoing manufacturing partnerships often involve CMOs.

2. Contract Manufacturing Organizations (CMOs)

Belinostat synthesis often involves third-party manufacturers to ensure scale and compliance with Good Manufacturing Practice (GMP):

• Fujifilm Diosynth Biotechnologies

  • Specializes in complex small molecule manufacturing.
  • Supplies active pharmaceutical ingredients (APIs) for various oncology drugs, including belinostat, under CDMO (Contract Development and Manufacturing Organization) contracts.

• Samsung Biologics

  • Known primarily for biologics, but involved in small molecule manufacturing for specialty compounds like belinostat via partnerships.

• Other CMOs:

  • Several smaller CMOs provide contract synthesis services for belinostat, often through licensing or development agreements. These include Pharmaron, WuXi AppTec, and Lonza.

3. Authorized Distributors

• McKesson Corporation and Cardinal Health:

  • Distribute belinostat in the U.S. via pharmacies and hospitals.
  • Stock both branded and generic formulations, depending on market availability.

• International Distributors:

  • Distribution networks in Europe (via Teva or Roche partners), Asia, and emerging markets often involve regional distributors.

4. Generic Manufacturers

• No major generic supplier as of 2023, due to patent protections and regulatory exclusivity periods primarily held by Spectrum Pharmaceuticals.
• Potential entrants are likely to emerge post-patent expiry, which is expected around 2024-2025, depending on jurisdictions.

5. Licensing and Supply Chain Dynamics

• Spectrum Pharmaceuticals maintains tight control over belinostat supply through licensing agreements with CMOs, which licensing is critical to ensure consistent quality and dosage standards.
• Due to its specialized synthesis and regulatory requirements, manufacturing is concentrated among few approved facilities.

Market Overview and Supply Chain Challenges

• Supply chain stability depends on the capacity of CMOs, which face increasing demand due to belinostat’s niche oncology indications.
• Regulatory approval processes restrict manufacturing to GMP-compliant facilities.
• Price pressure and patent expiries are creating opportunities for generic entrants, potentially expanding supplier bases in the future.

Summary Table of Belinostat Suppliers

Supplier Type	Notable Entities	Role / Notes
Original developer	Spectrum Pharmaceuticals	Commercial license holder, primary supplier in the U.S.
Contract Manufacturers (CMOs)	Fujifilm Diosynth, WuXi AppTec, Pharmaron	Synthesize active pharmaceutical ingredient (API), ensure regulatory compliance.
Distributors	McKesson, Cardinal Health	Distribute to healthcare providers and pharmacies.
Potential generic entrants	TBD upon patent expiry (expected 2024–2025)	Likely to establish new manufacturing and supply partnerships.

Key Takeaways

• Spectrum Pharmaceuticals is the primary commercial supplier for belinostat in the U.S.
• Manufacturing relies on a limited pool of CMOs with GMP capabilities.
• Distribution channels are established through major healthcare distributors.
• The absence of generics stems from patent exclusivity; expansion hinges on patent expiry.
• Supply chain stability depends mainly on CMO capacity and regulatory compliance.

FAQs

Q1: Who manufactures belinostat?
Spectrum Pharmaceuticals holds the licensing rights and works with CMOs such as Fujifilm Diosynth to produce belinostat.

Q2: Are there generic versions of belinostat?
As of 2023, no generic versions are available due to patent protections; generics may emerge post-patent expiry (~2024–2025).

Q3: Which distributors supply belinostat globally?
Major distributors like McKesson and Cardinal Health supply belinostat within the United States, while regional distributors handle international markets.

Q4: How is the supply chain for belinostat managed?
It relies on GMP-certified CMOs, licensing agreements, and distribution networks capable of handling complex oncologic therapies.

Q5: What risks could impact belinostat supply?
Manufacturing disruptions at CMOs, regulatory delays, or patent challenges could reduce supply availability.

---

References

1. U.S. Food and Drug Administration. (2014). Beleodaq (belinostat) prescribing information. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases
2. Spectrum Pharmaceuticals. (2023). Beleodaq product information. Retrieved from https://www.spectrumpharma.com
3. Pharmacopeia and regulatory filings. (2023). GMP manufacturing reports.
4. Market reports evaluating oncology drug supply chains. (2022). S&P Capital IQ datasets.