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Suppliers and packagers for CONCERTA
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CONCERTA
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Janssen Pharms | CONCERTA | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021121 | NDA | Janssen Pharmaceuticals, Inc. | 50458-585-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-585-01) | 2000-08-01 |
| Janssen Pharms | CONCERTA | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021121 | NDA | Janssen Pharmaceuticals, Inc. | 50458-586-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-586-01) | 2000-08-01 |
| Janssen Pharms | CONCERTA | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021121 | NDA | Janssen Pharmaceuticals, Inc. | 50458-587-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-587-01) | 2000-08-01 |
| Janssen Pharms | CONCERTA | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021121 | NDA | Janssen Pharmaceuticals, Inc. | 50458-588-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-588-01) | 2000-08-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for CONCERTA
Concerta (methylphenidate) suppliers: who manufactures, supplies, and sources the drug in the US and abroad?
Concerta is a branded extended-release methylphenidate product owned by Janssen Biotech, Inc. (Janssen). The commercial and regulatory supply chain is split between (1) the marketing authorization holder and (2) the listed manufacturers tied to FDA labeling and drug product manufacturing sites used for commercial distribution.
Key supplier pattern: Concerta is not a single-source “API supplier” model; it is a finished-dose drug supply model where multiple parties can be involved across API (methylphenidate HCl) and finished-dose manufacturing, packaging, testing, and release.
Who supplies Concerta in the US and what manufacturers are listed for the finished drug?
The FDA drug product listing and label manufacturing sections identify the finished product manufacturing sites responsible for manufacturing, packaging, and release for marketed strengths and dosage forms. For Concerta, the supply chain is typically concentrated among a small set of branded-finished-dose manufacturing partners and packaging/testing contractors used for commercial batches.
What to look for in FDA labeling and databases (high-signal supplier identifiers)
- Applicant/Marketing Authorization holder (brand owner): determines regulatory responsibility for commercial supply.
- Manufacturer of drug product: identifies where the extended-release tablets are made.
- Packager/Distributor: identifies where packaging and distribution are controlled.
- Testing/release sites: identifies analytical testing and batch disposition responsibility.
Dosage forms covered by the Concerta supply chain
- Extended-release oral tablets
- Strengths commonly include 18 mg, 27 mg, 36 mg, 54 mg (varies by product availability and label updates).
(Note: supplier names tied to each strength and site are taken from FDA labeling and listing records. If you run a listing pull for “Concerta methylphenidate ER tablets” you will find the site-level manufacturers and packagers.)
Which companies supply the methylphenidate active ingredient used to make Concerta?
Concerta uses methylphenidate hydrochloride as the active ingredient. The API supply chain for methylphenidate typically involves:
- dedicated API manufacturers for controlled substances chemical intermediates and final API,
- API importers or distributors,
- contract manufacturing organizations (CMOs) that can produce methylphenidate API and deliver it to the finished-dose tablet manufacturer.
API sourcing structure in controlled-substance CNS stimulants
For methylphenidate ER brands, API supply constraints are driven by:
- DEA controlled substance handling and logistics,
- validated synthetic routes for methylphenidate HCl,
- batch release testing,
- inspection and qualification of supplier sites.
What is typically disclosed vs. what is not
- Finished-dose manufacturers are usually more directly identifiable from FDA drug labeling.
- API suppliers may be harder to map precisely unless disclosed via:
- DMF references,
- inspection history,
- labeling/manufacturing section crosswalks,
- supplier statements in regulatory documentation.
What is the manufacturing model for Concerta extended-release tablets (tablet technology and supplier roles)?
Concerta’s commercial supply is built around extended-release tablet manufacturing. The core supplier roles are:
1) Finished-dose tablet manufacturer (core drug product supplier)
- Manufactures the ER tablet structure and excipient blend.
- Runs process controls for dissolution and release profiles.
- Conducts in-process and release testing or contracts it out.
2) Packaging supplier (secondary supply)
- Performs bottle filling, blister packaging, labeling application.
- Manages compliance labeling and controlled distribution requirements.
3) Testing and batch release (QC supplier role)
- Analytical testing for content uniformity, dissolution, impurity profile.
- Batch disposition and documentation package review.
How do you identify “true” Concerta suppliers for procurement: Orange Book listings, label sections, and site-level GMP?
Procurement-grade supplier identification uses a tri-layer verification approach:
Layer A: FDA drug product listing and label “Manufactured for / Distributed by”
- Confirms the marketing authorizing entity and site(s) that manufacture and package the drug product.
Layer B: Orange Book coverage and strength-specific manufacturing
- The Orange Book identifies active ingredient and may link to product identifiers and patent coverage.
- It does not always enumerate API suppliers, but it helps tie product-level manufacturing/marketing to the correct brand.
Layer C: GMP inspection readiness
- For supply contracts, the operational supplier must have:
- validated ER tablet capability,
- controlled-substance GMP systems,
- stable dissolution and release specification performance.
How many suppliers support Concerta distribution and what is the typical redundancy?
Brand stimulant supply chains often use:
- a primary finished-dose manufacturer,
- at least one alternate or secondary packaging/testing site,
- regional or global distribution partners for fulfillment.
The goal is continuity for chronic-use medicines where shortages trigger:
- allocation,
- substitute dispensing pathways,
- regulatory reporting.
Does Concerta have multiple manufacturing sites or is it concentrated to one finished-dose supplier?
Most large branded CNS stimulants show concentration at the finished-dose tablet stage with additional redundancy at packaging and testing. The supplier concentration profile for Concerta can be verified by checking:
- label “Manufactured by” site entries,
- packaging line descriptions,
- changes across label revisions.
What are the supply risks for Concerta (API shortages, manufacturing delays, controlled-substance logistics)?
API and intermediate risks
- Limited synthetic route capacity for methylphenidate HCl.
- Regulatory constraints around controlled-substance manufacturing.
Finished-dose risks
- ER tablet release specs are sensitive to manufacturing conditions.
- Supply is impacted by equipment downtime, scale-up changes, and batch failures.
Packaging and distribution risks
- Packaging material lead times (bottles, labels) can delay release.
- Distribution holds when batch release documentation is incomplete.
How does Concerta supply compare with generic methylphenidate ER suppliers?
Generic supply typically broadens manufacturing
- Generics often have multiple ANDA-specific generic tablet manufacturers.
- Supplier redundancy is usually higher across multiple generic entrants.
Brand supply can be narrower
- Branded ER products can use fewer manufacturing partners to protect quality consistency and release performance.
What suppliers matter most for contracting: finished-dose manufacturer vs. API supplier?
For procurement and supply assurance, the highest-impact suppliers are:
- Finished-dose tablet manufacturer (critical path for production capacity and release specs).
- Packaging and labeling supplier (critical path for sell-through readiness).
- QC and batch release site (critical path for compliance release).
- API supplier (critical path for sustained production runs, especially under controlled-substance constraints).
Key Takeaways
- Concerta supply is structured around finished-dose tablet manufacturing and packaging, with the brand owner holding regulatory responsibility.
- Finished-dose manufacturers are the most actionable “supplier” counterparties for procurement because they tie directly to marketed product release.
- Methylphenidate API sourcing can involve additional upstream suppliers, but API-specific supplier names are less consistently exposed publicly than finished-dose sites.
- Supply continuity risks come from ER manufacturing constraints, controlled-substance logistics, and batch release testing.
FAQs
Which company makes Concerta tablets?
Concerta is manufactured through FDA-labeled finished-dose manufacturing sites supporting the branded product authorization holder.
Who supplies methylphenidate API for Concerta?
API is sourced from methylphenidate hydrochloride supply channels used by branded manufacturers; API supplier identities are typically not as consistently listed publicly as finished-dose sites.
Are there multiple manufacturers for Concerta different strengths?
Concerta strength supply can involve the same or different manufacturing/packaging sites depending on label updates and batch sourcing.
What supply partner roles are most critical for Concerta continuity?
Finished-dose manufacturing, packaging, and batch release/testing sites are the critical path.
How do Concerta suppliers differ from generic methylphenidate ER suppliers?
Generics often have broader manufacturing networks across entrants; branded Concerta may be more concentrated among selected finished-dose partners.
References (APA)
(No sources were provided in the prompt and no public supplier/site records were supplied for verification, so no citations can be produced.)
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