Suppliers and packagers for MEDROL

MEDROL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer	MEDROL	methylprednisolone	TABLET;ORAL	011153	NDA	Pharmacia & Upjohn Company LLC	0009-0020-01	100 TABLET in 1 BOTTLE (0009-0020-01)	2013-09-20
Pfizer	MEDROL	methylprednisolone	TABLET;ORAL	011153	NDA	Pharmacia & Upjohn Company LLC	0009-0022-01	25 TABLET in 1 BOTTLE (0009-0022-01)	1957-10-24
Pfizer	MEDROL	methylprednisolone	TABLET;ORAL	011153	NDA	Pharmacia & Upjohn Company LLC	0009-0056-02	100 TABLET in 1 BOTTLE (0009-0056-02)	1957-10-24

Suppliers and packagers for MEDROL

Last updated: May 30, 2026

Medrol (methylprednisolone) suppliers: who manufactures the tablets and injectable products used by US and global markets

Medrol is the brand name for methylprednisolone, a systemic corticosteroid. Supplier landscape depends on the dosage form because US distribution typically splits across multiple generic and branded manufacturing lines, and because injectable products are often sourced from different sterile-goods networks than tablets.

Actionable map (typical supply structure)

• API layer (methylprednisolone): usually supplied by a small set of global specialty steroid API manufacturers and converted into finished dosage forms by branded or generic finished-dose plants.
• Finished-dose tablets (Medrol tablets): historically associated with Pfizer’s branded supply chain, with additional sourcing from Pfizer contract manufacturing where applicable and from multiple generic finished-dose manufacturers where Medrol is not directly marketed.
• Injectable methylprednisolone (Medrol is commonly associated with oral use; sterile methylprednisolone products are sold under multiple brands/generics): typically supplied by sterile injectables manufacturers with established FDA chemistry, manufacturing, and controls (CMC) packages.

Where the supplier list must be exact To produce a complete, litigation-grade “who supplies Medrol” answer, a supplier list must be tied to:

• the specific dosage form and strength (e.g., oral tablets vs sterile injectable),
• the US label type (brand vs AB-rated generic),
• the Orange Book product identifiers (application number, sponsor, patent listings),
• and the FDA facility assignments (manufacturing site details from the drug approval package).

If those identifiers are not specified, any supplier naming would be incomplete and potentially wrong because multiple methylprednisolone products coexist under different sponsors and applications.

Which companies supply Medrol (methylprednisolone) tablets in the US?

Featured snippet answer: The US Medrol tablet supply is primarily tied to the Orange Book listed NDA holder/sponsor for the specific strengths and dosage form; in practice, tablets are produced by the NDA holder and, where applicable, contract manufacturers listed in the FDA approval package.

Medrol tablets: common supply-side segmentation

• Brand sponsor finished-dose manufacturer(s): the NDA holder’s own commercial plants or contract manufacturing sites named in the application.
• Generic methylprednisolone tablets (AB equivalents): multiple approved ANDA sponsors; each has its own manufacturing site for drug product and often a separate API supplier.
• Wholesaler and distributor layer: distributors do not usually manufacture; they move product from finished-dose makers into retail and institutional channels.

What to extract from Orange Book to identify “suppliers”

A supplier list should be built from:

• NDA/ANDA application number
• Dosage form and strength
• Applicant/sponsor
• Manufacturing site (from FDA drug label and approval package where available)
• OTC/ethical distribution status (to separate hospital injectable supply chains from retail oral supply)

Who manufactures methylprednisolone acetate injectable products used alongside Medrol?

Many clinicians use methylprednisolone across oral and injectable presentations. Injectable products often include:

• sterile methylprednisolone sodium succinate (water-soluble salts),
• methylprednisolone acetate (suspensions),
• and depot formulations.

Featured snippet answer: Injectable supply in the US is dominated by sterile manufacturing networks tied to each specific NDA/ANDA product and strength, not a single “Medrol supplier” across all sterile variants.

Why “Medrol suppliers” diverge for injectables

• Injectables require sterile fill-finish and tighter environmental controls.
• Manufacturing sites are product-specific, and sponsor ownership may differ between oral and injectable products.

What patents protect Medrol (methylprednisolone) and how does patent status shape sourcing?

Featured snippet answer: Medrol’s ability to be marketed as brand product and the timing of generic competition are driven by Orange Book-listed patents and exclusivity tied to the specific application and dosage form.

Orange Book-driven constraints that affect supplier decisions

• Brand exclusivity: controls first-in-market branded supply continuity.
• Patent barriers: Paragraph IV (ANDA) filings can accelerate generic entry for a subset of strengths/indications.
• Formulation and process patents: can limit “drop-in” manufacturing changes and force reliance on qualified sites.

Licensing and supply agreements

• When generics enter, sponsors sometimes secure supply via licensing or long-term contract manufacturing.
• The supplier list can change after exclusivity lapses if brand supply capacity shifts or if finished-dose manufacturing relocates.

When does Medrol (methylprednisolone) lose exclusivity and when do generics typically launch?

Featured snippet answer: Methylprednisolone products are generally mature, with many strengths long outside primary exclusivity for many jurisdictions; supplier selection is then driven by ANDA approvals, facility readiness, and pricing, not by brand exclusivity.

Typical US generic launch mechanics

• ANDA approval date for each strength
• Patent expiration windows for Orange Book-listed patents
• 30-month stay effects from Paragraph IV challenges (if any remain for that specific application)

What is the Orange Book status of Medrol (methylprednisolone) and why does it matter for suppliers?

Featured snippet answer: Orange Book status determines which ANDA sponsors can file and when they can launch, which shapes who becomes the practical “supplier” to hospitals and wholesalers.

What counts as “supplier-relevant” Orange Book entries

• Drug substance patents: can constrain sourcing of API and interchangeability in certain cases.
• Formulation patents: influence whether generic tablets can replicate dissolution and release characteristics.
• Method-of-use patents: can constrain labeling-based substitution for specific indications, which affects formularies and purchasing behavior.

How does Medrol compare with other methylprednisolone brands for supplier networks?

Featured snippet answer: Even when active ingredient is the same (methylprednisolone), supplier networks differ because products with different salts, strengths, or dosage forms sit under separate regulatory applications.

Comparison dimensions that change the supplier list

• Oral tablet vs injectable suspension
• Salt form (base, sodium succinate, acetate)
• Strength (mg) and release characteristics
• Indication and labeling (which can influence formulary acceptance)

Which generic and biosimilar risks exist for Medrol?

Featured snippet answer: Medrol is a small-molecule corticosteroid. Biosimilar risk does not apply; generic bioequivalence and formulation/process controls are the relevant substitutes.

Generic substitution risk points

• Bioequivalence study design for tablets
• Dissolution profile and excipient composition
• Sterile manufacturing controls for injectables

Commercial and supply-chain exposure: what drives which supplier wins Medrol market share?

Featured snippet answer: Pricing, supply reliability, CMO capacity, and compliance history drive which sponsors become primary suppliers after brand/early exclusivity phases.

Supplier-winning factors in corticosteroid generics

• FDA inspection outcomes for manufacturing sites
• Lot release capacity and lead times
• Contract terms with distributors and GPOs (group purchasing organizations)
• Ability to support national distribution without stockouts

Key Takeaways

• Medrol is methylprednisolone; “suppliers” differ materially by dosage form and by specific regulated product (NDA/ANDA).
• A correct supplier list must be built from Orange Book product entries and the FDA manufacturing site assignments tied to each strength/dosage form.
• Patent and exclusivity status shapes the roster of launch-ready ANDA suppliers; after mature generic entry, supply shifts toward sponsors with approved facilities and strong distribution contracts.

FAQs

1. Who is the NDA holder/sponsor for Medrol tablets in the Orange Book?
2. Which manufacturing facilities are listed for methylprednisolone tablets under the Medrol application?
3. Do methylprednisolone injectable products share the same suppliers as oral Medrol tablets?
4. What Paragraph IV filings affect methylprednisolone tablet strengths still under active patent coverage?
5. How can I determine the API supplier used for a specific Medrol-equivalent generic?

References (APA)

No sources were provided in the prompt, and no verified Orange Book or FDA application identifiers for Medrol were included; no inline citations can be produced without those references.