Suppliers and packagers for recarbrio

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

Suppliers and packagers for recarbrio

Last updated: April 26, 2026

Who supplies the inputs behind RECARBRIO (imipenem and cilastatin/relebactam)?

RECARBRIO is a fixed-dose antibacterial composed of imipenem and cilastatin plus relebactam. Public documentation on supplier chains is fragmented: filings typically identify the marketing authorization holder and manufacturing sites, not the full upstream supplier list for every active and excipient. Within the limits of what is consistently disclosed in regulatory and branded-manufacturing records, the following supplier relationships are identifiable at the drug-product level for RECARBRIO.

What parties are named in publicly available records as manufacturers or commercial suppliers?

Record type	Named supplier/manufacturer (publicly listed)	Geography	What it indicates
U.S. prescribing information / regulatory product labeling	Merck Sharp & Dohme LLC (U.S. marketing authorization holder)	U.S.	Branded product responsible party in the U.S.
U.S. product labeling (manufacturing site callouts)	Selected manufacturing sites listed for the drug product (by facility in the labeling)	U.S.	The company/facility that produces and releases RECARBRIO drug product for market
EMA product dossier / European branding records	Merck entities and named manufacturing sites	EU	Drug product manufacturing and release sites for the European market

Key point: For RECARBRIO, supplier identification in public sources most reliably resolves to (1) the brand authorization holder and (2) the named drug-product manufacturing and release facilities. Upstream suppliers for API and excipient inputs are not consistently published in a way that supports an authoritative, end-to-end “bill of materials supplier map” across jurisdictions.

Which parts of RECARBRIO supply chain are most clearly disclosed publicly?

1. Drug product manufacturing and release
   • Labeling and dossier documentation generally name the facility(ies) that manufacture and release the finished formulation, sometimes including contract manufacturing organizations.
2. Regulatory responsible party
   • U.S. and EU records identify the commercial sponsor or marketing authorization holder associated with RECARBRIO distribution.
3. Not consistently disclosed
   • Full upstream list of API suppliers for imipenem/cilastatin and relebactam
   • Full upstream list of excipients (by vendor)
   • Intermediates and sterile-fill partners in subcontractor chains unless specifically disclosed at the manufacturing site level in public listings

What does this mean for R&D and procurement decisions?

For due diligence and supplier onboarding, the practical path supported by public records is:

• Validate the drug-product manufacturing and release facility for each market (U.S., EU).
• Use that facility’s identity to drive supplier qualification for:
  • API procurement interfaces
  • Drug product sterile/aseptic handling responsibilities
  • Serialization and distribution controls

This approach aligns to what labeling and regulatory records actually disclose for RECARBRIO’s commercial product.

---

Key Takeaways

• Publicly verifiable supplier relationships for RECARBRIO are anchored to the marketing authorization holder and the named drug-product manufacturing and release facilities in labeling and regulatory product records.
• Upstream API and excipient vendor lists are not consistently disclosed in a way that supports a complete, authoritative supplier map from public sources alone.
• For procurement and supply assurance work, the most defensible starting point is the drug-product manufacturing/release site(s) named in the approved product documentation.

---

FAQs

1. Who is the marketing authorization holder for RECARBRIO in the U.S.?
   Merck Sharp & Dohme LLC is the U.S. marketing authorization holder shown in U.S. prescribing information.

2. Do public sources list the suppliers of the APIs for RECARBRIO (imipenem, cilastatin, relebactam)?
   Not in a consistent, complete way across jurisdictions. Public documentation most reliably identifies the finished drug-product manufacturing/release facilities rather than upstream API vendors.

3. What is the most reliable publicly disclosed “supplier” category for RECARBRIO?
   The drug-product manufacturing and release facility(ies) named in labeling and regulatory records.

4. Are supplier lists the same across the U.S. and Europe for RECARBRIO?
   They can differ by market because manufacturing and release sites can change by region, but both regions use named facilities in their respective regulatory/product records.

5. How should a buyer approach supplier qualification for RECARBRIO inputs based on public data?
   Start with the named drug-product manufacturing/release facility, then trace upstream API and excipient procurement through qualification questionnaires and contractual supply disclosures tied to that site.

---

References

[1] U.S. Food and Drug Administration. RECARBRIO (imipenem and cilastatin/relebactam) prescribing information. FDA label database.
[2] U.S. National Library of Medicine. RECARBRIO drug label information (DailyMed). DailyMed.
[3] European Medicines Agency. RECARBRIO (imipenem/cilastatin/relebactam) product information and EPAR documentation. EMA.