Last Updated: June 9, 2026

Suppliers and packagers for generic pharmaceutical drug: OXYTOCIN


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OXYTOCIN

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Fresenius Kabi Usa OXYTOCIN oxytocin INJECTABLE;INJECTION 018248 NDA Cardinal Health 107, LLC 55154-9584-5 5 VIAL in 1 BAG (55154-9584-5) / 1 mL in 1 VIAL 2000-08-10
Fresenius Kabi Usa OXYTOCIN oxytocin INJECTABLE;INJECTION 018248 NDA Fresenius Kabi USA, LLC 63323-012-07 25 VIAL in 1 TRAY (63323-012-07) / 1 mL in 1 VIAL (63323-012-17) 2000-08-10
Fresenius Kabi Usa OXYTOCIN oxytocin INJECTABLE;INJECTION 018248 NDA Fresenius Kabi USA, LLC 63323-012-10 25 VIAL, MULTI-DOSE in 1 TRAY (63323-012-10) / 10 mL in 1 VIAL, MULTI-DOSE (63323-012-06) 2000-08-10
Fresenius Kabi Usa OXYTOCIN oxytocin INJECTABLE;INJECTION 018248 NDA Fresenius Kabi USA, LLC 63323-012-11 25 VIAL in 1 TRAY (63323-012-11) / 1 mL in 1 VIAL (63323-012-03) 2000-08-10
Fresenius Kabi Usa OXYTOCIN oxytocin INJECTABLE;INJECTION 018248 NDA Fresenius Kabi USA, LLC 63323-012-30 10 VIAL, MULTI-DOSE in 1 TRAY (63323-012-30) / 30 mL in 1 VIAL, MULTI-DOSE (63323-012-02) 2000-08-10
Fresenius Kabi Usa OXYTOCIN oxytocin INJECTABLE;INJECTION 018248 NDA Fresenius Kabi USA, LLC 65219-021-01 25 VIAL, SINGLE-DOSE in 1 TRAY (65219-021-01) / 1 mL in 1 VIAL, SINGLE-DOSE (65219-021-00) 2024-05-06
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for generic pharmaceutical drug: OXYTOCIN

Last updated: May 25, 2026

Oxytocin Drug Suppliers (API, Finished Dosage, and Contract Manufacturing)

Oxytocin is widely sourced globally because it is off-patent in most markets and available in multiple commercial strengths and dosage forms. The practical supplier map typically splits into (1) injectable oxytocin API and (2) finished-dose injectable products (vials/ampoules), plus (3) contract manufacturing organizations (CMOs) supporting sterile injectables.

The sections below identify the main supplier categories and the supplier sets that dominate the market in regulated regions, using observable market behavior: multiple branded and generic injectable offerings, recurring tender/stocking patterns, and repeated manufacturer presence in distribution networks.


Who are the main pharmaceutical suppliers of oxytocin injections?

Oxytocin is supplied as sterile injectable products (commonly 10 IU/mL in 1 mL ampoules or vials), sold as branded versions in some regions and as generics by multiple international manufacturers.

Top finished-dose manufacturers (common global presence)

Finished-dose oxytocin injectables are offered by multiple global generic and specialty sterile-drug manufacturers, with frequent availability through hospital wholesalers.

Commonly encountered suppliers include:

  • Ferring Pharmaceuticals (branded and/or legacy products in multiple markets)
  • Mylan / Viatris (generics presence across multiple regions historically)
  • Hospira (brand legacy in many markets; sterile injectables network)
  • Pfizer (historical brand presence in some regions depending on product line)
  • B. Braun (hospital-focused injectable supply in multiple geographies)
  • Sandoz (generic injectable supplier footprint)
  • Teva (generic injectable footprint in multiple markets)
  • Accord / Accord Healthcare (generic footprint in Europe and other regions)

These companies typically appear as either finished-dose labelers, marketing authorisation holders, or manufacturers behind commercial product offerings depending on the country.

Regional distributor and tender supply

In many hospital systems, oxytocin is procured via:

  • national tender lists
  • hospital group group purchasing organizations
  • wholesalers that repackage or stock multiple authorized labeler SKUs

Because oxytocin is used in delivery rooms, supply continuity matters more than differentiation, which drives multi-sourcing strategies.


Which companies supply oxytocin active pharmaceutical ingredient (API)?

Oxytocin API sourcing is usually done by fewer specialized peptide/API manufacturers, because peptide synthesis and cGMP sterile-adjacent controls for peptide APIs require specific capabilities. API supply chains can also serve as the base for sterile injectable finished-dose manufacture.

In practice, API is commonly sourced from a mix of:

  • global peptide API makers
  • generic API specialists supplying multiple finished-dose manufacturers
  • internal supply chains from vertically integrated sterile injectables companies

How oxytocin API is typically distributed

API often moves through:

  • converted into finished sterile injectables by a contract sterile manufacturer
  • packaged and released by a finished-dose manufacturer under its marketing authorisation

This means market “supplier” listings often reflect finished-dose labelers rather than API producers, unless explicitly stated in procurement documents.


What contract manufacturers make oxytocin sterile injections for other brands?

Sterile injectable contract manufacturing is where “brand owners” often outsource bulk sterile filling and finishing. For oxytocin, CMOs typically cover:

  • sterile liquid filling into ampoules and vials
  • siliconized ampoule line compatibility
  • freeze tolerance and viscosity handling
  • aseptic processing and sterility assurance
  • packaging into trays or hospital packs

Covers usually used in sterile injection CMO capability matrices

  • Aseptic processing (aseptic filling lines)
  • Penicillin-safe suites (not relevant unless used for cross-industry; often included)
  • QA release testing and stability program management
  • Container closure system compatibility
  • Batch record support for peptide stability

While exact CMO subcontractors vary by product and country, the commercial reality is that multiple oxytocin brands share the same sterile filling infrastructure through subcontracting.


Which countries have the largest oxytocin supply networks and authorized manufacturers?

Oxytocin is most reliably available where hospital procurement is mature and where generic sterile injectable capacity exists.

High-supply jurisdictions

  • United States (multiple labeled generics via established sterile networks; frequent wholesaler availability)
  • European Union (high generic manufacturer density; multiple marketing authorisations)
  • United Kingdom (similar EU-linked authorization and distribution channels, post-Brexit changes)
  • India (large generic sterile and API base; frequent export)
  • China (domestic supply plus export routes)
  • Canada (select authorized manufacturers)

Where shortages tend to matter operationally

Supply disruptions tend to impact countries that rely heavily on a small number of tender-listed SKUs or a limited set of importers.


What formulations and strengths are supplied by major oxytocin manufacturers?

Oxytocin market supply is dominated by injectable liquid products.

Common oxytocin injectable dosage forms

  • Injectable solution (sterile)
  • Concentrations commonly marketed include 10 IU/mL
  • Presentation formats:
    • 1 mL ampoules
    • 5 mL vials in some markets
    • multi-dose vials depending on country and hospital protocol

Practical procurement note

Hospitals standardize around IU per mL and pack format for delivery room workflows. This drives brand loyalty to specific SKUs more than to “manufacturer” identity.


How do supply chains differ between branded oxytocin and generics?

Branded products

Branded products often come from manufacturers with:

  • legacy supply continuity
  • centralized quality oversight and stable procurement
  • fewer tender substitutions

Generic products

Generic products often compete on:

  • price
  • pack size
  • availability in tender windows
  • substitution flexibility in formularies

Because oxytocin is standardized, generic acceptance depends on regulator-approved equivalence and supplier reliability.


What are typical lead times and distribution models for oxytocin suppliers?

Distribution model

Oxytocin usually follows:

  • bulk manufacturing release
  • distributor warehousing
  • hospital direct shipment on PO schedules

Lead-time behavior in practice

Lead times shorten for:

  • established multiple-source suppliers
  • markets where finished-dose generics are stocked in wholesaler distribution centers

Lead times lengthen during:

  • API-level disruptions
  • sterile manufacturing line shutdowns
  • import container constraints
  • tender-induced order spikes

What supplier risks exist for oxytocin supply continuity?

The core operational risks include:

  • sterile injectable batch failures (sterility assurance, particulate issues)
  • peptide stability handling and storage condition deviations
  • container closure compatibility issues (ampoule breakage rates, seal integrity)
  • regulatory variation in batch release criteria per jurisdiction

For buyers, risk is mitigated by:

  • multi-sourcing
  • qualifying alternative packs
  • maintaining safety stock around critical formulary SKUs

How to compare oxytocin suppliers for procurement: what to evaluate?

A procurement scoring model for oxytocin suppliers typically uses:

  1. Regulatory status: approved marketing authorisation in the buying jurisdiction
  2. Product form: ampoule vs vial, and IU/mL concentration alignment
  3. Supply reliability: historical fill rates and stockout rates via tender records
  4. Quality system: sterile aseptic capability, batch release turnaround
  5. Packaging logistics: hospital-friendly pack configuration and labeling compliance
  6. Commercial terms: landed cost, MOQs, delivery lead time, allocation rules

Key Takeaways

  • Oxytocin injections are supplied primarily as finished-dose sterile injectables, with multiple globally established generic suppliers and legacy branded suppliers.
  • The supplier ecosystem is multi-layered: fewer specialized peptide/API suppliers feed a broader set of sterile injectable finished-dose manufacturers and CMOs.
  • Procurement continuity depends on sterile manufacturing capacity, regulatory release stability, and multi-sourcing discipline rather than on differentiated product technology.

FAQs

Which oxytocin manufacturers supply 10 IU/mL ampoules in hospitals?

Multiple global generic and established sterile injectable suppliers offer 10 IU/mL presentations in ampoules depending on country tender lists and regulatory approvals.

Are there differences in excipients that affect substitution between oxytocin brands?

Substitution can be sensitive to excipient composition and container closure system, even when the active ingredient is equivalent. Hospital formulary decisions typically rely on regulator-approved equivalence plus compatibility with administration protocols.

Do oxytocin supplies rely on a small number of peptide API producers?

Peptide API production is specialized, so the upstream pool is narrower than the downstream finished-dose supplier set, which increases the importance of multi-sourcing at the API or filled-dose level.

What is the best way to secure continuous oxytocin supply for delivery rooms?

Qualify more than one approved SKU (pack format and concentration) and maintain safety stock aligned to your procurement lead times.

Which region has the widest availability of oxytocin generics?

Markets with high generic sterile injectable capacity and mature wholesaler distribution networks, commonly including parts of Europe, India, and the US, tend to have the widest availability.


References

  1. FDA Orange Book. U.S. Food and Drug Administration. (Product listings and exclusivity status for oxytocin generics where available).
  2. EMA product information and publicly available EPAR/SmPC databases for approved oxytocin-containing products. European Medicines Agency.
  3. WHO Model Lists and procurement guidance for oxytocin as an essential medicine. World Health Organization.

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