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Suppliers and packagers for RECARBRIO
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RECARBRIO
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Msd Merck Co | RECARBRIO | cilastatin sodium; imipenem; relebactam | POWDER;INTRAVENOUS | 212819 | NDA | Merck Sharp & Dohme LLC | 0006-3856-02 | 25 VIAL, SINGLE-DOSE in 1 CARTON (0006-3856-02) / 20 mL in 1 VIAL, SINGLE-DOSE (0006-3856-01) | 2020-01-06 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Recarbrio
Introduction
Recarbrio (imipenem, cilastatin, and relebactam) is an advanced broad-spectrum antibiotic formulation designed to combat multidrug-resistant bacterial infections. Authorized for hospital use, particularly in complicated urinary tract infections (cUTIs) and intra-abdominal infections (cIAIs), Recarbrio's complex composition necessitates a reliable supply chain from multiple specialized manufacturers. Ensuring steady access to the constituent ingredients and finished drug products is vital given its critical role in combating resistant pathogens.
Manufacturing Components and Their Suppliers
Recarbrio's efficacy hinges on three primary components:
- Imipenem – a carbapenem antibiotic.
- Cilastatin – a dose-enhancer that prevents imipenem degradation.
- Relebactam – a β-lactamase inhibitor that extends antimicrobial activity.
Each component involves specialized chemical synthesis processes often conducted by different suppliers globally.
1. Suppliers of Imipenem
Imipenem serves as the cornerstone of Recarbrio's activity. It is produced via complex fermentation and chemical synthesis processes, requiring high-purity standards to ensure clinical safety.
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Major Manufacturers:
- Sandoz (Novartis division): Historically, Sandoz has supplied imipenem formulations, leveraging its global manufacturing footprint.
- Micros Laboratories (India): Known for synthesizing β-lactam antibiotics, including imipenem and related carbapenems.
- Hikma Pharmaceuticals: A globally recognized producer of injectable antibiotics, including imipenem-cilastatin formulations.
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Key Attributes of Suppliers:
- Regulatory Approvals: Suppliers must comply with US FDA, EMA, and other stringent regulatory agencies to ensure Good Manufacturing Practice (GMP) standards.
- Supply Capacity and Flexibility: Given the drug's critical nature, suppliers have scaled production to meet global demand surges, especially during health emergencies.
- Quality Control: Suppliers employ rigorous quality assurance protocols, including spectroscopic and chromatographic testing, to adhere to pharmacopeial standards.
2. Suppliers of Cilastatin
Cilastatin prevents renal degradation of imipenem, enhancing its durability and efficacy.
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Leading Suppliers:
- Sandoz (Novartis): A primary supplier for clinical and commercial formulations.
- Hikma Pharmaceuticals: Produces high-quality cilastatin, often integrated into fixed-dose combinations.
- Gral Latin America and other regional manufacturers: Supply cilastatin for regional distribution, ensuring sustained supply lines.
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Regulatory and Quality Standards:
Suppliers are required to meet stringent manufacturing standards. Cilastatin's synthesis involves complex chemical processes that must satisfy purity and stability requirements per pharmacopeial standards.
3. Suppliers of Relebactam
Relebactam, as a newer β-lactamase inhibitor, has a more limited manufacturer base owing to its recent approval and complex synthesis pathway.
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Primary Developer:
- Merck & Co. (MSD): Developed Recarbrio and supplies relebactam as part of its integrated manufacturing process.
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Contract Manufacturing and Licensing:
- Contract Manufacturing Organizations (CMOs): Some biotech firms licensed to produce relebactam on behalf of Merck, including specialized firms with capabilities in advanced organic synthesis.
- Supply Chain Considerations: The limited number of producers underscores the importance of supply chain stability. Merck's global manufacturing facilities are strategically located to meet worldwide demand.
Global Supply Chain Dynamics and Risks
The supply chain for Recarbrio is vulnerable to regional disruptions, regulatory delays, and capacity limitations. Notable considerations include:
- Geopolitical Factors: Trade restrictions, tariffs, and regional conflicts can impede component flow.
- Regulatory Approvals and Inspections: Suppliers must maintain GMP compliance to avoid penalties or supply halts.
- Raw Material Sourcing: Precursors and active pharmaceutical ingredients (APIs) depend on reliable suppliers; shortages can impact production timelines.
- Manufacturing Capacity Expansion: The ongoing need for capacity increases, especially amid antimicrobial resistance challenges, prompts continuous investment in manufacturing facilities.
Key Industry Partnerships and Licensing Agreements
Major pharmaceutical companies often establish strategic alliances:
- Merck’s Vertical Integration: Owns extensive manufacturing capabilities for relebactam, ensuring supply continuity.
- Licensing and Contract Manufacturing: Many regional suppliers operate under licensing agreements with originators, facilitating localized production and reducing lead times.
Regulatory and Quality Considerations
Suppliers for Recarbrio must navigate complex regulatory landscapes:
- Compliance with GMP: Critical for market authorization across jurisdictions.
- Documentation and Traceability: Enhanced batch tracking and documentation are standard to meet regulatory audits.
- Validation Processes: Suppliers undergo rigorous validation to ensure consistency in potency, purity, and stability.
Emerging Trends and Future Outlook
- Supply Chain Diversification: To mitigate risks, companies are diversifying supplier bases, investing in regional manufacturing hubs.
- Technology Adoption: Implementation of advanced continuous manufacturing techniques promises increased efficiency and product consistency.
- Sustainable Manufacturing: There's a push towards environmentally sustainable practices aligned with global regulations.
Conclusion
The supply network for Recarbrio comprises a curated selection of high-caliber, GMP-compliant manufacturers specializing in the synthesis of imipenem, cilastatin, and relebactam. Major industry players such as Novartis (Sandoz), Hikma Pharmaceuticals, and Merck are central to the supply chain, ensuring the continuous availability of this critical antibiotic. The global pharmaceutical landscape remains vigilant to supply chain vulnerabilities, emphasizing diversification, quality assurance, and regulatory compliance as pillars for uninterrupted supply.
Key Takeaways
- Recarbrio's production depends on multiple specialized suppliers for imipenem, cilastatin, and relebactam, with key players including Novartis (Sandoz), Hikma Pharmaceuticals, and Merck.
- Supply chain stability is critical due to the complex synthesis, stringent quality standards, and limited manufacturer base for relebactam.
- Regional manufacturing hubs and strategic licensing agreements help mitigate geopolitical and logistical risks.
- Regulatory compliance and high quality assurance standards underpin all suppliers, ensuring safety and efficacy.
- Ongoing industry initiatives focus on diversification and sustainability to address future supply challenges for vital antibiotics like Recarbrio.
Frequently Asked Questions (FAQs)
1. Who are the main manufacturers of Recarbrio’s active ingredients?
Major manufacturers include Novartis (Sandoz) for imipenem and cilastatin, Hikma Pharmaceuticals, and Merck & Co. for relebactam. These companies operate globally, adhering to strict GMP standards.
2. How is supply chain security maintained for critical antibiotics like Recarbrio?
Through diversification of supplier bases, regional manufacturing facilities, strategic licensing agreements, and rigorous regulatory oversight, companies ensure minimal disruptions.
3. Are there regional differences in Recarbrio component sourcing?
Yes. Regional suppliers serve local markets, often through licensing and regional manufacturing to reduce dependency on centralized sources, enhancing supply resilience.
4. What challenges could disrupt the supply of Recarbrio?
Potential disruptions include geopolitical tensions, raw material shortages, regulatory delays, manufacturing capacity constraints, or compliance issues at supplier facilities.
5. How are new suppliers qualified to produce Recarbrio’s components?
They undergo comprehensive qualification processes, including GMP audits, validation studies, quality control assessments, and regulatory approvals before integration into the supply chain.
Sources
- [1] FDA Drug Approvals Database. Recarbrio: Product information and manufacturing details.
- [2] European Medicines Agency (EMA). Recarbrio Summary of Product Characteristics.
- [3] Merck & Co. Official disclosures on relebactam manufacturing capabilities.
- [4] Industry reports on global antibiotic manufacturing capacity and strategic partnerships.
- [5] Pharmaceutical industry trade publications covering supply chain trends and infrastructure investments.
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