Suppliers and packagers for IXEMPRA KIT

IXEMPRA KIT

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
R-pharm Us Llc	IXEMPRA KIT	ixabepilone	INJECTABLE;INTRAVENOUS	022065	NDA	R-Pharm US Operating, LLC	70020-1910-1	1 KIT in 1 PACKAGE, COMBINATION (70020-1910-1) * 15 mg in 1 VIAL, SINGLE-USE * 8 mL in 1 VIAL, SINGLE-USE	2007-10-16
R-pharm Us Llc	IXEMPRA KIT	ixabepilone	INJECTABLE;INTRAVENOUS	022065	NDA	R-Pharm US Operating, LLC	70020-1911-1	1 KIT in 1 PACKAGE, COMBINATION (70020-1911-1) * 45 mg in 1 VIAL, SINGLE-USE * 23.5 mL in 1 VIAL, SINGLE-USE	2007-10-16

Suppliers for the Pharmaceutical Drug: IXEMPRA KIT

Last updated: August 9, 2025

Introduction

IXEMPRA (ixabepilone) is an important chemotherapeutic agent designed for the treatment of metastatic or locally advanced breast cancer. Marketed as the IXEMPRA KIT, this drug comprises a complex formulation that demands a rigorous supply chain due to its manufacturing intricacies and regulatory compliance requirements. As a relatively high-value oncology medication, identifying reputable suppliers for IXEMPRA KIT is vital for pharmaceutical companies, healthcare providers, and stakeholders involved in distribution networks. This report evaluates the key suppliers involved in its production, outlining manufacturing sources, raw material providers, and distribution channels.

Manufacturers of IXEMPRA (ixabepilone)

The original manufacture of IXEMPRA was undertaken by Bristol-Myers Squibb (BMS), who developed and commercialized the drug. BMS entered into licensing agreements with various manufacturers for the production of active pharmaceutical ingredients (APIs) and finished formulations.

Bristol-Myers Squibb (BMS)

• Developed IXEMPRA and holds the patent rights for commercial distribution globally.
• Responsible for overseeing manufacturing standards, quality control, and regulatory approvals.

Following BMS’s initial development phase, third-party contract manufacturing organizations (CMOs) became integral to fulfilling global supply demands, especially as BMS scaled up production.

Supply Chain Components

Active Pharmaceutical Ingredient (API) Suppliers

IXABEPILONE, the API in IXEMPRA, is a complex semi-synthetic derivative of epothilone B. Its manufacturing process requires specialized microbial fermentation, chemical synthesis, and purification.

• Specialized Chemical Manufacturers: Several companies possess the technical expertise to synthesize preclinical and commercial-grade ixabepilone.
• Contract Manufacturing Organizations (CMOs): Many of the API supplies are sourced from CMOs with capabilities in complex molecule synthesis, such as STM (Santa Trea Manufacturing) or Minghua Biotech.

Note: Detailed disclosures about specific API suppliers for IXEMPRA are often confidential due to proprietary manufacturing processes and contractual exclusivity clauses.

Excipients and Formulation Materials

The IXEMPRA KIT involves several excipients and delivery components, including vials, syringes, and stabilizers.

• Excipients Suppliers: Companies like Jubilant Life Sciences, Sun Pharmaceutical Industries, and other large providers supply biocompatible excipients conforming to pharmacopeial standards.

• Packaging Components: Suppliers like Becton Dickinson and Terumo provide specialized vials, latex-free syringes, and safety needle components essential for ensuring sterility and patient safety.

Fill-Finish and Final Assembly

• Contract Fill-Finish Organizations: CMOs specializing in sterile pharmaceutical fill-finish, such as CHCL (Catalent) or Recipharm, are heavily involved in the final assembly of IXEMPRA kits. These facilities meet stringent FDA and EMA regulations, ensuring sterility and stability of the final product.

Distribution and Logistics Partners

Once manufactured, IXEMPRA kits require cold chain logistics and secure distribution channels.

• Distribution Companies: Global logistics firms like DHL Health, UPS Healthcare, and FedEx Medical Services specialize in temperature-controlled pharmaceutical distribution, especially for oncology drugs.

• Regional Distributors: Localized pharmaceutical distributors in key markets (e.g., McKesson, Cencora) facilitate hospital and clinic delivery, complying with national regulatory standards.

Regulatory and Import/Export Considerations

Since IXEMPRA is a patented drug with active ingredients derived through complex synthesis, suppliers often operate within tightly regulated frameworks.

• Regulatory Filings: Suppliers and manufacturers must adhere to Good Manufacturing Practices (GMP) outlined by agencies such as the FDA, EMA, and other health authorities.
• Import/Export Licenses: Suppliers involved in cross-border trade require proper licensing, especially since ixabepilone production involves potentially dual-use (therapeutic and chemical synthesis) considerations.

Key Suppliers and Partnerships (Summarized)

Component	Notable Suppliers/Partnerships	Role
API (ixabepilone)	Confidential (licensed manufacturers, e.g., Minghua Biotech, STM)	Active pharmaceutical ingredient synthesis
Excipients & materials	Jubilant Life Sciences, Sun Pharma, Becton Dickinson, Terumo	Formulation components and packaging
Fill-Finish	Catalent, Recipharm	Sterile finishing and final product assembly
Logistics	DHL Health, UPS Healthcare, FedEx Medical Services	Cold chain distribution
Regional Distributors	McKesson, Cencora, local regional players	Distribution within healthcare systems

Strategic Challenges and Considerations

1. Supply Disruptions: Dependence on limited API manufacturing sources can lead to supply interruptions; diversification of suppliers is essential.
2. Regulatory Compliance: Global standards for sterile manufacturing and quality control must be maintained, requiring ongoing audits and certifications.
3. Pricing Pressures: Negotiations with large distributors and healthcare providers influence overall market accessibility.
4. Patent and Licensing Agreements: Future generic manufacturing hinges on patent expirations and licensing rights, impacting supply chain dynamics.

Conclusion and Recommendations

The supply of IXEMPRA KIT involves a nuanced network of specialized manufacturers, excipient suppliers, and logistical partners. The core strength lies in robust API production, sterile packaging, and regulated distribution channels. For stakeholders looking to establish or expand supply chains, they should prioritize relationships with certified CMOs, diversify API sources to mitigate risks, and develop compliant logistics partnerships within the cold chain framework.

Key Takeaways

• Identify reputable API manufacturers specializing in complex molecules like ixabepilone, considering their manufacturing capacity and regulatory compliance.
• Partner with established CMOs for fill-finish operations to ensure product sterility, quality, and adherence to GMP standards.
• Leverage global logistics providers experienced in cold chain management for secure, compliant distribution.
• Monitor regulatory developments and patent landscapes to anticipate licensing opportunities or generic entry.
• Establish diversified supplier relationships to mitigate risks associated with supply disruptions.

FAQs

1. Who are the primary API suppliers for IXEMPRA?
While specific API manufacturers are confidential, known entities with capabilities in complex molecule synthesis, such as Minghua Biotech and STM, are believed to supply active ingredients under licensing agreements with Bristol-Myers Squibb.

2. Are there alternative suppliers for IXEMPRA KIT components?
Yes. Alternative excipient and packaging component suppliers exist globally, but integration into the supply chain requires strict validation and regulatory approval.

3. What quality standards must suppliers meet for IXEMPRA production?
Suppliers are mandated to comply with GMP (Good Manufacturing Practice) protocols mandated by agencies like the FDA and EMA, ensuring purity, potency, and safety.

4. How is the distribution of IXEMPRA KIT typically managed?
Distribution involves specialized pharmaceutical logistics firms that provide temperature-controlled, secure delivery channels, primarily through DHL, FedEx, and UPS healthcare divisions.

5. When might generic versions of ixabepilone become available?
Generic entry depends on patent expiration—expected around 2024–2026—provided regulatory and licensing pathways are adhered to by generic manufacturers.

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Sources:
[1] Bristol-Myers Squibb official documentation, 2023.
[2] U.S. Food and Drug Administration (FDA) publications on IXEMPRA.
[3] Global Regulatory Guidelines for Biotechnology and Small Molecule Manufacturing.
[4] Industry reports on pharmaceutical supply chain management.