Suppliers and packagers for DURAMORPH PF

DURAMORPH PF

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hikma	DURAMORPH PF	morphine sulfate	INJECTABLE;INJECTION	018565	NDA	Hikma Pharmaceuticals USA Inc.	0641-6019-10	10 AMPULE in 1 CARTON (0641-6019-10) / 10 mL in 1 AMPULE (0641-6019-01)	1984-09-18
Hikma	DURAMORPH PF	morphine sulfate	INJECTABLE;INJECTION	018565	NDA	Hikma Pharmaceuticals USA Inc.	0641-6020-10	10 AMPULE in 1 CARTON (0641-6020-10) / 10 mL in 1 AMPULE (0641-6020-01)	1984-09-18
Hikma	DURAMORPH PF	morphine sulfate	INJECTABLE;INJECTION	018565	NDA	Hikma Pharmaceuticals USA Inc.	0641-6039-01	20 mL in 1 AMPULE (0641-6039-01)	1984-09-18

Suppliers and packagers for DURAMORPH PF

Last updated: June 4, 2026

Duramorph PF (morphine sulfate injection) suppliers: who manufactures, packages, and supplies the branded product?

Duramorph PF is the branded, preservative-free injectable form of morphine sulfate used for analgesia (including perioperative and obstetric settings). The supply chain for a branded injectable typically includes (1) the drug substance and drug product manufacturing site(s), (2) the packaging and labeling site(s), and (3) distributors/wholesalers that supply hospitals and pharmacies.

If you need a supplier map for Duramorph PF, the authoritative way to identify the manufacturing and distribution parties is the product’s FDA labeling and the Orange Book/Drug Applications and Labeling records tied to the NDC(s) for the exact dosage strength and presentation (Duramorph PF is not a single monolithic SKU). Those records list the manufacturing/packaging sites and sponsor holders used in regulatory submissions.

Who supplies Duramorph PF to hospitals and distributors?

Answer: In the US market, branded hospital injectables are generally supplied through national wholesalers and specialized hospital distributors, while the underlying manufacturer is identified on the FDA label for each NDC strength/presentation.

How to identify the “supplier” that matters

For procurement, litigation, or licensing diligence, “supplier” can mean different legal or operational entities:

• Labeler / Marketing authorization holder (the firm responsible for the listed drug product in regulatory submissions)
• Manufacturer of record (drug product manufacturing site)
• Packager/labeler (packaging and labeling site)
• Wholesaler/distributor (the commercial distribution channel into accounts)

What determines the correct supplier list

Duramorph PF exists in multiple strengths and vial formats. Each NDC can point to different manufacturing and packaging arrangements. Without tying to the exact NDC(s) and strength/presentation, any supplier list is incomplete.

What companies manufacture Duramorph PF drug product under NDA/labeling?

Answer: The drug product manufacturer is the company listed under the “Manufactured for” / “Distributed by” sections of the FDA-approved labeling for the relevant NDC.

Common manufacturing role split for injectables

For preservative-free injectables, the supply chain often separates:

• Sterile bulk manufacturing
• Aseptic filling
• Vial/ampule packaging
• Labeling and distribution

These functions can sit with the same company or be split across contractors.

Why suppliers differ by NDC

Different vial sizes or strengths can be produced on different lines, at different aseptic fill/finish sites, or packaged by different contractors. That can shift the “supplier” entity even when the active ingredient is unchanged.

Which patent holders and licensing entities control Duramorph PF’s branded supply?

Answer: Brand supply does not require a single “supplier” controlling entity; it is controlled by the marketing authorization and manufacturing supply agreements, while patent exclusivity can affect competitive entry timing.

Branded morphine sulfate injection: typical IP scope that affects supply

For legacy opioids in branded formats, IP often includes one or more of:

• formulation patents (for specific packaging/preservation-free presentation)
• manufacturing/sterility and process patents
• method-of-use patents for specific clinical protocols

Why this matters to supplier mapping

If there are formulation/process patents tied to a specific presentation, the branded label’s manufacturing partner may be contractually constrained, and alternative fill/finish sites may have different access to the protected process.

What is the Orange Book status of Duramorph PF and what does it imply for sourcing?

Answer: Orange Book status is checked per NDC and strength. If the product is a listed drug with active patents, that does not directly name the manufacturing supplier, but it frames the degree of regulatory and IP freedom for competitors.

Orange Book listings to check for each NDC

• Patent numbers and expiration dates
• Submission type (drug substance vs drug product vs method of use)
• Patent scope (formulation vs process vs indication)

Practical implication for procurement

• If patents are still active, alternative branded sourcing may come only from the same label holder or authorized contract partners.
• If patents are expired, suppliers can shift more readily through generic or authorized distributor channels.

Does Duramorph PF have generic or authorized-entry risks that change supplier availability?

Answer: Supplier availability changes when competitors file and win access routes (e.g., FDA approvals for the same dosage form and strength, or switching due to drug shortages).

The entry mechanisms that alter supply chain

• Generic approvals for morphine sulfate injection presentations
• Substitution at pharmacy procurement level
• Hospital formularies switching branded products

How that impacts “who supplies”

When generic competitors gain approvals, wholesalers may carry multiple labelers, which increases sourcing flexibility for hospitals. That does not change the branded manufacturer but changes the commercial supply options.

What manufacturing/IP barriers exist for Duramorph PF re-sourcing or contract fill/finish?

Answer: For preservative-free sterile injectables, key barriers are usually:

• aseptic processing capability
• sterile fill/finish validation
• control strategy for particle burden and microbiological acceptance
• documentation traceability required under cGMP

If there are formulation or process patents tied to the exact preservative-free presentation, contract manufacturing may be constrained by licensing rights.

Comparative supplier map: Duramorph PF vs other preservative-free morphine sulfate injections

Answer: Supplier structure typically differs by brand label and NDC, even among preservative-free morphine sulfate products.

What to compare

For each product, map:

• labeler/marketing authorization holder
• NDCs and presentation
• manufacturing site(s)
• packaging/labeling site(s)
• distribution channel partners

Why this matters

In procurement and outage risk management, the key is whether alternative suppliers share the same bottleneck fill/finish lines or regulator-licensed sterile sites.

Key Takeaways

• “Supplier for Duramorph PF” must be defined by role: labeler/marketing authorization holder, drug product manufacturer, packager/labeler, and commercial distributor.
• The only defensible supplier list is tied to the exact NDC(s) for the Duramorph PF strength and vial presentation, using the FDA label and regulatory records.
• Patent/Orange Book status shapes competitive entry and can indirectly affect whether branded production is tied to specific authorized manufacturing partners.
• For sterile preservative-free injectables, supply resilience depends on fill/finish capacity, aseptic process validation, and cGMP documentation control.

FAQs

1. How do I identify the manufacturer and packager for Duramorph PF by NDC?
   Check the “Manufactured for/Distributed by” and packaging/labeling sections of the FDA-approved label for the specific NDC strength/presentation.

2. Is Duramorph PF supplied by multiple manufacturers or only one?
   Multiple manufacturers are possible across strengths and NDCs due to line capacity and contract packaging arrangements, but confirmation requires NDC-specific label review.

3. Do Duramorph PF patents affect who can supply the injectable?
   They can affect whether competitors can lawfully market a competing version and whether authorized manufacturing partners can replicate protected formulation/process attributes.

4. What typically causes Duramorph PF supply shortages?
   Sterile fill/finish constraints, batch rejection rates, aseptic capacity limits, and upstream drug substance supply disruptions.

5. How can hospitals switch between Duramorph PF and alternatives without changing patient outcomes?
   They typically switch by NDC-equivalent presentation and dosing equivalents under pharmacy and therapeutics committee policies, guided by FDA labeling and substitution rules.

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026-06-05).
2. U.S. Food and Drug Administration. Drug Labeling (DailyMed and FDA labeling records for morphine sulfate injection, preservative-free). (Accessed 2026-06-05).
3. U.S. FDA. Drugs@FDA database for morphine sulfate injection products associated with Duramorph PF brand presentations. (Accessed 2026-06-05).