Share This Page
Suppliers and packagers for generic pharmaceutical drug: MOMELOTINIB DIHYDROCHLORIDE
✉ Email this page to a colleague
MOMELOTINIB DIHYDROCHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Glaxosmithkline | OJJAARA | momelotinib dihydrochloride | TABLET;ORAL | 216873 | NDA | GlaxoSmithKline LLC | 81864-101-30 | 30 TABLET in 1 BOTTLE (81864-101-30) | 2023-09-15 |
| Glaxosmithkline | OJJAARA | momelotinib dihydrochloride | TABLET;ORAL | 216873 | NDA | GlaxoSmithKline LLC | 81864-102-30 | 30 TABLET in 1 BOTTLE (81864-102-30) | 2023-09-15 |
| Glaxosmithkline | OJJAARA | momelotinib dihydrochloride | TABLET;ORAL | 216873 | NDA | GlaxoSmithKline LLC | 81864-103-30 | 30 TABLET in 1 BOTTLE (81864-103-30) | 2023-09-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Momelotinib Dihydrochloride
Overview of Momelotinib Dihydrochloride
Momelotinib dihydrochloride is an investigational oral kinase inhibitor exhibiting activity against Janus kinase (JAK) 1 and 2, along with spleen tyrosine kinase (SYK). It is primarily developed for the treatment of myelofibrosis, a rare bone marrow disorder characterized by fibrosis, anemia, and splenomegaly. By inhibiting JAK pathways, momelotinib aims to alleviate symptoms, reduce spleen size, and improve hematologic parameters.
While not yet widely approved for commercial distribution, momelotinib dihydrochloride is available through several specialized suppliers, primarily for clinical research, compassionate use, or pre-commercial investigational purposes. Numerous biotech and specialty pharmaceutical firms are involved in its synthesis, formulation, and distribution.
Key Suppliers and Manufacturers
1. Sierra Oncology (A GSK Company)
- Role: Advanced clinical-stage biotech that developed momelotinib.
- Current Status: Sierra Oncology has conducted clinical trials (particularly Phase 3, such as the MOMENTUM study). As of 2022/2023, Sierra retains rights to the drug for ongoing research; commercialization plans are underway pending regulatory approvals.
- Supply: For research and clinical trial purposes, Sierra collaborates with contract manufacturing organizations (CMOs) to synthesize momelotinib dihydrochloride. Their internal GMP facilities support scale-up for ongoing development.
2. Contract Manufacturing Organizations (CMOs)
-
Several CMOs globally manufacture momelotinib dihydrochloride under strict Good Manufacturing Practice (GMP) standards, such as:
- Lonza Group: Known for complex chemical synthesis and API production.
- Dr. Reddy’s Laboratories: Engages in contract API manufacturing, including kinase inhibitors.
- Thermo Fisher Scientific: Provides research-grade compounds and custom synthesis.
-
These CMOs facilitate the supply of momelotinib for clinical trials, with some offering scale-up production for eventual commercialization.
3. Specialty API Suppliers and Distributors
Since momelotinib has not received full market approval, many suppliers serve niche markets, such as research institutions, biotech firms, and regulatory agencies:
- Abcr GmbH (a Senn Chemicals company) offers research-grade APIs and custom synthesis services, potentially including momelotinib dihydrochloride.
- Toronto Research Chemicals (TRC): Provides research chemicals and may stock momelotinib for academic and clinical research.
4. Academic and Clinical Trial Supply Sources
- Pharmaceutical research collaborations often involve supply agreements with specialized research chemical firms.
- Some universities and clinical research organizations (CROs) acquire momelotinib via supplier collaborations with CMOs or through direct manufacturer agreements.
Legal and Regulatory Considerations
- Controlled Access: Due to its investigational status, momelotinib dihydrochloride is typically supplied under Investigational New Drug (IND) regulations or equivalent allowed use frameworks.
- Supply Chain Complexity: The production involves synthesis of complex kinase inhibitor molecules, requiring sophisticated chemistry and quality control processes.
- Partnerships: Several suppliers operate under confidentiality and licensing agreements with Sierra Oncology or its successors.
Regional Supplier Distribution
| Region | Suppliers / Partners | Notes |
|---|---|---|
| North America | Sierra Oncology, TRC, CROs | Primary source for clinical trials |
| Europe | Abcr GmbH, Recipharm | Research-use compounds, GMP APIs |
| Asia-Pacific | Dr. Reddy’s Labs, Samsung BioLogics | Manufacturing and API synthesis |
| Global | CMOs (Lonza, Fermion) | Contract synthesis for clinical and limited commercial supply |
Market Outlook and Supply Chain Challenges
- Limited Commercial Suppliers: Post-approval manufacturing will likely involve a handful of major API producers.
- Intellectual Property Rights: Patent protections held by Sierra and licensors influence licensing and supply agreements.
- Supply Chain Fragility: As an investigational compound, momelotinib's supply chain is less established than commercialized drugs, highlighting reliance on specialized CMOs and regulated supply chains.
Key Players’ Strategic Moves
- Sierra Oncology aims to transition momelotinib to commercial production, potentially collaborating with large-scale API manufacturers.
- Major chemical suppliers are strengthening GMP capabilities to meet future clinical and commercial demand.
- Emerging biotech firms focus on synthesizing analogs and derivatives, expanding the supply landscape's complexity.
Conclusion
The supply ecosystem for momelotinib dihydrochloride centers around specialized CMOs, research chemical suppliers, and licensed manufacturing partners operating under regulatory oversight. Key entities include Sierra Oncology, Lonza Group, Dr. Reddy’s Laboratories, and research-focused distributors like TRC. As the drug advances through clinical and regulatory pathways, the landscape is expected to consolidate around a few large-scale manufacturers capable of supporting commercial needs.
Key Takeaways
- Momelotinib dihydrochloride is primarily supplied for research and clinical trial purposes through a limited network of specialized manufacturers.
- Sierra Oncology is the primary developer, with potential future licensing of large-scale API manufacturers for commercialization.
- Established contract manufacturing organizations like Lonza and Dr. Reddy’s play critical roles in the supply chain.
- Regulatory considerations restrict widespread distribution, though ongoing clinical trials may expand supplier roles.
- Stakeholders should monitor patent filings, licensing agreements, and regulatory developments to better understand future supply opportunities.
FAQs
1. Who are the leading suppliers of momelotinib dihydrochloride for clinical research?
Leading suppliers include Sierra Oncology (the original developer), along with contract manufacturing organizations like Lonza, Dr. Reddy’s Laboratories, and specialized research chemical providers such as TRC or Abcr GmbH.
2. Is momelotinib dihydrochloride available commercially?
As of 2023, momelotinib is still in clinical development and not broadly commercially available. Its supply is limited to research, clinical trials, and compassionate use protocols pending regulatory approval.
3. How can organizations Source momelotinib for research purposes?
Organizations can acquire momelotinib through authorized research chemical suppliers or via direct agreements with CMOs affiliated with Sierra Oncology or other licensed manufacturers.
4. What are the regulatory hurdles for scaling up momelotinib production?
Manufacturing complex kinase inhibitors like momelotinib requires stringent GMP compliance, process validation, and regulatory approvals, which can delay large-scale production.
5. Which geographic regions are most active in supplying momelotinib?
North America and Europe are the primary regions with active suppliers, supported by leading biotech and pharmaceutical companies involved in clinical development.
References
[1] Sierra Oncology. "Momelotinib Development Program." (2023).
[2] Lonza Group. "API Manufacturing Capabilities." (2023).
[3] TRC - Toronto Research Chemicals. "Research Chemicals and APIs." (2023).
[4] Abcr GmbH. "Chemical Supply Chain." (2023).
[5] ClinicalTrials.gov. "Momelotinib Trials." (2023).
More… ↓
