Suppliers and packagers for risperdal

risperdal

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	RISPERDAL	risperidone	SOLUTION;ORAL	020588	NDA	Janssen Pharmaceuticals, Inc.	50458-305-03	30 mL in 1 BOTTLE (50458-305-03)	1996-06-10
Janssen Pharms	RISPERDAL	risperidone	SOLUTION;ORAL	020588	NDA	Janssen Pharmaceutical, Inc.	50458-596-01	30 mL in 1 BOTTLE (50458-596-01)	1996-06-10
Janssen Pharms	RISPERDAL	risperidone	SOLUTION;ORAL	020588	NDA	REMEDYREPACK INC.	70518-3760-0	10 CUP, UNIT-DOSE in 1 BOX (70518-3760-0) / 2 mL in 1 CUP, UNIT-DOSE (70518-3760-1)	2023-06-12

Suppliers and packagers for risperdal

Last updated: May 31, 2026

Risperdal Suppliers: API, Manufacturing, and Packaging Sources by Formulation and Market

Risperdal (risperidone) is supplied through a layered chain: (1) active pharmaceutical ingredient (API) production, (2) solid or liquid drug-product manufacturing, and (3) finished-goods packaging and distribution. The set of “suppliers” that matter for IP, procurement, and regulatory diligence are the marketing authorization holder (MAH) for each country, the finished-dose manufacturers listed on regulatory filings, and the API sites supporting drug-product release.

No complete, accurate supplier list for Risperdal can be produced from the information provided.

Which companies are Risperdal suppliers for the API and drug product?

A supplier map for Risperdal must separate API manufacturers from finished-dose manufacturers because the Orange Book lists only certain US patent-linked drug-product information, while supply chains are reflected in NDA/ANDA facility lists, FDA Drug Registration and Listing (DRLM), and regional regulatory dossiers.

What is typically listed for Risperdal drug-product manufacturing?

For a branded CNS product like Risperdal, the FDA labeling typically points to a US distributor/holder and may list manufacturing sites through DRLM or the NDA. For non-US markets, listings are in each regulator’s product dossier.

What is typically used to identify the API supplier?

API suppliers are usually identified via:

• FDA DRLM for API establishments where applicable
• Site references in NDAs and supplement reporting
• Quality agreements tied to DMF holders or API re-packagers
• Compliance and inspection databases tied to site-level operations

What is the Orange Book status of Risperdal and what does that imply for suppliers?

If the objective is “supplier identification,” Orange Book status is used mainly to connect drug-product NDA/labeler with patent-protected dosage forms that have specific manufacturing and labeling responsibilities in the US.

Why Orange Book status matters to supplier mapping

• The labeler/holder in the Orange Book is the entity responsible for the NDA submission and marketing.
• Patent-protected forms affect which generic entrants can use which manufacturing routes, which in turn affects supplier selection for drug product.

Which Orange Book fields drive supplier decisions?

• NDA holder/labeler
• Dosage form and route (tablets, ODT, solution, long-acting injectable)
• Listed patents tied to the specific NDA and strength

Which Risperdal dosage forms have distinct supplier chains (tablets vs ODT vs injection)?

Risperdal is marketed across multiple formulations, and each formulation usually maps to different manufacturing lines and packaging suppliers.

How formulations change supplier sourcing

• Oral solids (tablets/ODT) use compression and blending lines
• Oral solutions use liquid manufacturing, filling, and container-closure validation
• Long-acting injectables (where applicable) require sterile manufacturing, pen/vial fill-finish, and cold-chain logistics

What patents protect Risperdal manufacturing and formulations, and do they constrain suppliers?

Supplier constraints are driven by whether the procurement target is for:

• branded manufacturing under license from the NDA holder
• generic manufacturing using a Paragraph IV route
• contract manufacturing that can legally operate within the applicable patent landscape

How supplier restrictions appear in real-world contracting

• Restriction clauses aligned to method patents and formulation patents
• Supply-chain gating to sites cleared for the relevant regulatory dossier
• License-based supply from contract manufacturers with validated technology platforms

Do biosimilars or biologics rules apply to Risperdal suppliers?

Risperdal is a small-molecule (risperidone). Biosimilar frameworks do not apply in the same way they do for biologics.

When does Risperdal lose exclusivity in major markets, and how does that affect suppliers?

Exclusivity and patent timelines determine:

• timing of generic launches
• switching opportunities in procurement
• potential requalification requirements for alternative manufacturers

What “exclusivity” means for supplier risk

• US patent expiration controls Paragraph IV strategies and launch dates
• Country-level data exclusivity impacts dossier acceptance timelines
• IRB/PMAs are not typically relevant for small-molecule CNS products, but manufacturing changes still drive regulatory updates

What generic entry risks exist for Risperdal in the US and EU that could change supplier rosters?

Generic entry changes suppliers in two ways:

1. generic drug product suppliers replace branded procurement
2. branded suppliers face price pressure, which can lead to site changes through contractual renegotiation

How to assess generic entry risk without a supplier roster

A supplier risk model needs patent-by-patent status and Orange Book listings linked to dosage forms, which are not provided here.

What manufacturing/IP barriers block switching Risperdal suppliers?

Switching typically triggers:

• process validation gaps
• regulatory comparability requirements
• stability and shelf-life confirmation
• changes in container-closure systems and packaging vendors

Packaging vendor barriers

Packaging for Risperdal strengths and formats includes:

• blister systems and film laminates for tablets/ODT
• bottle/closure systems for solution
• sterile packaging systems for injectables
  These require validated change control and regulatory reporting.

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Key Takeaways

• Risperdal supplier mapping must distinguish API sources, finished-dose manufacturers, and packaging/distribution entities.
• Orange Book and regulatory listing data drive the correct “supplier” definition for procurement and IP diligence.
• A complete and accurate supplier list cannot be generated from the information provided.

FAQs

1. How do I identify the contract manufacturer behind Risperdal tablets vs Risperdal solution?
2. Which FDA database fields show finished-dose manufacturing sites for a branded NDA like Risperdal?
3. Do Risperdal long-acting injectable products use different sterile manufacturing suppliers than oral formulations?
4. How do Orange Book labeler and NDA holder changes affect supplier contracting and compliance?
5. What triggers FDA or EMA requalification when switching Risperdal drug-product manufacturing sites?

References

1. FDA. Drug Registration and Listing System (DRLS). U.S. Food and Drug Administration.
2. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.