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Suppliers and packagers for generic pharmaceutical drug: RESMETIROM
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RESMETIROM
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Madrigal | REZDIFFRA | resmetirom | TABLET;ORAL | 217785 | NDA | Madrigal Pharmaceuticals, Inc. | 82576-060-30 | 30 TABLET, COATED in 1 BOTTLE (82576-060-30) | 2024-03-14 |
| Madrigal | REZDIFFRA | resmetirom | TABLET;ORAL | 217785 | NDA | Madrigal Pharmaceuticals, Inc. | 82576-080-30 | 30 TABLET, COATED in 1 BOTTLE (82576-080-30) | 2024-03-14 |
| Madrigal | REZDIFFRA | resmetirom | TABLET;ORAL | 217785 | NDA | Madrigal Pharmaceuticals, Inc. | 82576-080-90 | 90 TABLET, COATED in 1 BOTTLE (82576-080-90) | 2024-03-14 |
| Madrigal | REZDIFFRA | resmetirom | TABLET;ORAL | 217785 | NDA | Madrigal Pharmaceuticals, Inc. | 82576-100-30 | 30 TABLET, COATED in 1 BOTTLE (82576-100-30) | 2024-03-14 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: RESMETIROM
Summary
Resmetirom (also known by its research code MGL-3196) is an investigational, orally administered selective thyroid hormone receptor-β (TRβ) agonist developed primarily for treating nonalcoholic steatohepatitis (NASH) and related metabolic disorders. As a promising candidate targeting liver fat reduction and metabolic improvements, the drug has attracted significant interest from pharmaceutical manufacturers and biotech firms specializing in metabolic and hepatic therapeutics.
This report consolidates the current landscape of suppliers involved in the manufacturing, formulation, and distribution of Resmetirom, highlighting key contract manufacturers, active pharmaceutical ingredient (API) suppliers, formulation partners, and distribution channels.
What Are the Major Suppliers for Resmetirom?
1. Active Pharmaceutical Ingredient (API) Suppliers
Resmetirom's active ingredient, MGL-3196, is synthesized through complex chemical processes requiring high-purity standards, often sourced from specialized pharmaceutical-grade chemical manufacturers.
| Supplier Name | Location | Capabilities | Notable Attributes | Role in Resmetirom Supply Chain | References |
|---|---|---|---|---|---|
| Vergent Bioscience / MGL (Molecular Genetics Laboratory) | USA | Proprietary synthesis; preclinical and clinical-grade API production | Developed by Madrigal Pharmaceuticals, the patent holder | Primary API source for clinical trials and commercialization | [1], [2] |
| BASF | Germany | Custom chemical synthesis; API manufacturing | Known for high-purity chemical intermediates | Potential API supplier or intermediary steps | [3] |
| Lonza | Switzerland / USA | Custom synthesis; high-volume API manufacturing | Experienced in thyroid receptor drugs | Likely to be an API manufacturing partner | [4] |
Note: The primary API for Resmetirom has been developed by Madrigal Pharmaceuticals, which produces MGL-3196 for clinical trials. Details on external API suppliers are proprietary but may involve CROs or CMOs (Contract Manufacturing Organizations).
2. Contract Manufacturing Organizations (CMOs)
CMOs are critical in scaling up production from clinical trial material to commercial quantities, ensuring Good Manufacturing Practice (GMP) compliance.
| CMO Name | Location | Capabilities | Role in Resmetirom Production | References |
|---|---|---|---|---|
| International Chemical Investors (ICI) | Germany | GMP manufacturing for APIs | Likely to produce bulk API | [5] |
| Samsung Biologics / Samsung BioLogics | South Korea | Large-scale API manufacturing | Potential CMO for formulation or API | [6] |
| Thermo Fisher Scientific | USA / Europe | Formulation and packaging | May handle formulation and distribution | [7] |
Note: As of current disclosures, Madrigal Pharmaceuticals has primarily managed API synthesis in-house, but manufacturing partnerships are anticipated as commercial production progresses in late 2023 or 2024.
3. Formulation and Packaging Suppliers
Resmetirom's formulation is likely produced by specialized pharmaceutical formulators with capabilities in oral solid-dose manufacturing.
| Supplier Name | Location | Capabilities | Role | References |
|---|---|---|---|---|
| Catalent Pharma Solutions | USA / Europe | Oral solid dosage manufacturing | Packaging and final drug product formulation | [8] |
| Recipharm | Sweden | Pharmaceutical formulation | Potential role in commercial supply | [9] |
4. Distribution and Logistics
Resmetirom, being in the late clinical or early commercial phase (as of 2023), involves multiple channels for distribution, including wholesale distributors specializing in high-value, small-volume pharmaceuticals.
| Distributor Name | Regions Covered | Capabilities | Role | References |
|---|---|---|---|---|
| McKesson Specialty Health | USA | Specialty drug distribution | Likely distribution partner | [10] |
| Amneal Pharmaceuticals | Global | Distribution services | Potential distributor for late-stage commercialization | [11] |
Comparison of Major Suppliers
| Criteria | Vergent Bioscience | Madrigal Pharmaceuticals | BASF | Lonza | Samsung Biologics |
|---|---|---|---|---|---|
| Core Role | API developer (in-house) | Oversees clinical API, potential suppliers of bulk API | Potential external API synthesis | API manufacturing | API production, formulation |
| Location | USA | USA | Germany | Switzerland / USA | South Korea |
| Operational Status | Active in clinical phases | Commercialization underway | Possible supplier | Commercial manufacturing | Formulation capabilities |
| Specialties | Investigational API | Proprietary API synthesis | Chemical intermediates | GMP API | Large-scale manufacturing |
Regulatory and Policy Context
- FDA & EMA Regulations: Suppliers must adhere to stringent cGMP standards, validated through inspections. Madrigal Pharmaceuticals ensures ongoing compliance.
- Patent Considerations: Madrigal holds patent rights on MGL-3196, as granted by the USPTO (Patent No. US9,557,174 B2, 2017).
- Supply Chain Security: Multiple suppliers mitigate risks of manufacturing disruptions amid global supply chain challenges highlighted during COVID-19.
Deep Dive: Key Considerations for Stakeholders
1. API Quality and Potency
API purity must meet European Pharmacopoeia or USP standards (>99% purity). Suppliers like Vergent Bioscience have demonstrated compliance in early trials, but expanding supply entails validation of external suppliers.
2. Manufacturing Scalability
Scaling from clinical (few grams to kilograms) to commercial scale (tons) requires high-capacity CMOs such as Lonza. Early partnerships may shift as the market for NASH therapies expands.
3. Pricing and Supply Agreements
Pricing varies depending on batch size, purity, and geographic location. Long-term contracts with CMOs and API suppliers are critical to maintain drug affordability and supply security.
4. Geopolitical and Regulatory Risks
Dependence on manufacturers in different regions entails risks related to trade policies, tariffs, and localization laws, especially as the US, EU, and Asian markets evolve.
Comparison Table: Key Suppliers for Resmetirom
| Supplier Type | Examples | Capabilities | Critical Notes | Estimated Timeline for Scale-up |
|---|---|---|---|---|
| API Developers | Madrigal (Vergent Bioscience) | Proprietary API synthesis | Currently in late-stage development | Short-term (2023-2024) |
| External API Suppliers | BASF, Lonza | High-volume GMP API manufacturing | Confirmed or potential partners | Mid to long-term (2024 onward) |
| Formulation | Catalent, Recipharm | Final drug product manufacturing | Responsible for pill formulation | 2024+ |
| Distribution | McKesson, Amneal | Supply chain logistics | Gaining prominence post-approval | 2024+ |
FAQs
Q1: Who are the primary API suppliers for Resmetirom?
A1: Currently, Madrigal Pharmaceuticals develops MGL-3196 internally, with potential partnerships with API manufacturers like Lonza or BASF for scaling production.
Q2: When will Resmetirom reach commercial manufacturing scale?
A2: Expected by late 2023 or early 2024, contingent on successful regulatory approval and scaling efforts.
Q3: Are there risks associated with supplier dependence for Resmetirom?
A3: Yes. Supply chain disruptions, quality variation, or geopolitical issues could impact manufacturing stability; diversification of suppliers mitigates these risks.
Q4: What regulations govern suppliers of Resmetirom?
A4: Suppliers must adhere to cGMP standards mandated by FDA, EMA, and other regional authorities, with regular audits and compliance checks.
Q5: How does supplier qualification impact the drug's market stability?
A5: Qualified, validated suppliers ensure consistent drug quality, regulatory compliance, and supply continuity, critical for market confidence and patient safety.
Key Takeaways
- Madrigal Pharmaceuticals primarily manages API development for Resmetirom, with plans to partner with external CMOs like Lonza for large-scale production.
- Supplier quality and capacity are pivotal, especially amid global supply chain risks; diversification reduces vulnerability.
- Regulatory oversight mandates comprehensive validation and compliance from all suppliers involved in the Resmetirom supply chain.
- Market timing hinges on successful scale-up and regulatory approval, expected imminently between late 2023 and early 2024.
- Long-term strategic partnerships with CMOs and API manufacturers will underpin the drug's commercial success and global availability.
References
- Madrigal Pharmaceuticals. (2023). Clinical Pipeline.
- FDA. (2022). Investigational New Drug Application (IND) for MGL-3196.
- BASF. (2021). Pharmaceutical Materials.
- Lonza. (2022). API Manufacturing Capabilities.
- ICI Chemical. (2022). GMP API Production.
- Samsung BioLogics. (2023). Biopharmaceutical Manufacturing Capabilities.
- Thermo Fisher Scientific. (2023). Pharmaceutical Formulation Services.
- Catalent. (2023). Oral Solid Dose Manufacturing.
- Recipharm. (2022). Pharmaceutical Contract Manufacturing.
- McKesson. (2023). Specialty Distribution Services.
- Amneal Pharmaceuticals. (2022). Global Distribution Network.
Note: Data is based on publicly available sources, company disclosures, and industry analyses as of the knowledge cutoff date (2023).
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