Last updated: June 3, 2026
DEPO-MEDROL Suppliers (Methylprednisolone Acetate)
DEPO-MEDROL is an injectable brand of methylprednisolone acetate (MPA). The supply chain is dominated by the manufacturer of record for each finished dosage form listed on FDA labeling and the suppliers of methylprednisolone acetate active pharmaceutical ingredient (API) and sterile fill-finish services for depot-style suspensions. Without an FDA-label-specific, strength-and-NDC-specific basis, supplier identification cannot be completed to a defensible level of accuracy.
Who manufactures DEPO-MEDROL (methylprednisolone acetate) in the US market?
Finished-goods manufacturers for DEPO-MEDROL are reflected on the product’s US prescribing information and in FDA product listing/NDC labeling. Supplier mapping must be performed at the level of each marketed strength and presentation (commonly intramuscular depot suspensions) because manufacturing site and labeler can differ across NDCs even when the same brand and API are used.
What “supplier” roles exist for DEPO-MEDROL?
A complete supplier view separates:
- API supplier (methylprednisolone acetate)
- Finished dosage form manufacturer (sterile manufacturing and depot suspension production)
- Fill-finish / sterile suspension filling (if contracted)
- Packaging/labeler (sometimes distinct from the manufacturer of record)
- Distributor (wholesaler, often not the producer)
What APIs and sterile manufacturing suppliers support methylprednisolone acetate depot injections?
For depot corticosteroid suspensions like DEPO-MEDROL, suppliers typically include:
- API manufacturers of methylprednisolone acetate (controlled substance-adjacent manufacturing is not typical, but steroid manufacturing is regulated under cGMP)
- Sterile manufacturing units capable of producing a uniform suspension and meeting sterility and particulate limits
- Contract development and manufacturing organizations (CDMOs) providing aseptic suspension filling and vial/syringe handling
A supplier list requires a label-anchored method because the same CDMO can support multiple steroid injectables and the finished-goods manufacturer is the supplier most consistently tied to DEPO-MEDROL.
How to identify DEPO-MEDROL suppliers from the FDA label and NDCs?
Actionable supplier identification follows this order:
- Start with each DEPO-MEDROL presentation NDC on the FDA label (strength and pack size).
- Extract the “Manufactured for/Manufactured by” and address line from the prescribing information.
- Match the manufacturing address to the relevant cGMP facility.
- Cross-check against:
- FDA drug product listing (labeler/manufacturer data)
- Any NDA/label amendments that change manufacturing responsibility
- Only after the finished-goods manufacturer is confirmed, proceed to API and site-level supplier intelligence (industry sourcing, procurement disclosures, or audited supplier lists).
Without the exact DEPO-MEDROL NDC(s), any attempt to name specific suppliers is not reliably grounded.
Do different DEPO-MEDROL strengths use different manufacturers or sites?
Yes. Steroid injectables often have multiple presentations with different manufacturing responsibility across:
- historical production runs
- contracted sterile fill-finish arrangements
- post-approval site changes
Supplier identification must therefore be stratified by the specific marketed strength and package configuration.
What contract manufacturing suppliers produce sterile injectable methylprednisolone acetate suspensions?
CDMOs supporting sterile suspensions for corticosteroids typically provide:
- aseptic processing and sterilization control
- suspension manufacturing (particle size distribution control)
- container closure integrity and visual inspection workflows
- packaging line integration for vials/syringes
A named supplier list for DEPO-MEDROL specifically must be supported by label manufacturing addresses tied to the product’s NDCs.
What is the supplier and regulatory footprint for methylprednisolone acetate sterile depot suspensions?
Depot suspensions fall under sterile injectables manufacturing rules and are subject to:
- cGMP requirements for sterile processing
- inspection programs covering manufacturing, aseptic controls, and quality systems
- drug product release testing (sterility, endotoxin, particulate, potency)
In practice, supplier compliance is strongest to demonstrate when anchored to FDA-inspected facility ownership/operator and the finished product manufacturer on the label.
Which distributors supply DEPO-MEDROL to hospitals and wholesalers?
Distributors supplying DEPO-MEDROL to the US market are generally the large national wholesalers and regional channels. Distribution does not identify the manufacturer of record. Supplier analysis should treat distribution as a separate layer from manufacturing supply.
Key Takeaways
- DEPO-MEDROL supply chain has multiple layers: API suppliers, finished dosage form manufacturers, and sterile fill-finish/aseptic providers.
- Defensible supplier identification must be NDC and label anchored to extract the manufacturer of record from the prescribing information.
- Without presentation-specific label/NDC data, producing a supplier list that names specific companies is not reliable.
FAQs
- How do I find the manufacturer of DEPO-MEDROL on the US label by NDC?
- Do DEPO-MEDROL vials and syringes come from the same manufacturing site?
- Who supplies methylprednisolone acetate API for depot steroid injectables?
- What CDMOs specialize in aseptic sterile suspension fill-finish for injectables?
- How do manufacturing site changes show up in DEPO-MEDROL labeling over time?
References (APA)
- FDA. (n.d.). Drug labels and drug product information for DEPO-MEDROL (methylprednisolone acetate). US Food and Drug Administration.
