Suppliers and packagers for pentasa

pentasa

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Takeda Pharms Usa	PENTASA	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	020049	NDA	Takeda Pharmaceuticals America, Inc.	54092-189-81	240 CAPSULE in 1 BOTTLE (54092-189-81)	1993-05-10
Takeda Pharms Usa	PENTASA	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	020049	NDA	Takeda Pharmaceuticals America, Inc.	54092-191-12	120 CAPSULE in 1 BOTTLE (54092-191-12)	2004-07-08

Suppliers and packagers for pentasa

Last updated: May 31, 2026

Pentasa (mesalazine) Suppliers: Manufacturers, API Sources, and Contract Supply Footprints by Region

Pentasa is the brand for mesalazine (5-aminosalicylic acid; 5-ASA) used in inflammatory bowel disease. Commercial supply chains typically split between (1) mesalazine API and (2) finished-dose manufacture for oral delayed-release and rectal formulations. This article maps the major known supplier landscape for Pentasa products by dosing form and trading geography, and ties supply relationships to the most common commercialization patterns for mesalazine brands (multiple finished-dose manufacturers, shared API nodes, and regional packaging).

Who manufactures Pentasa tablets and suppositories (finished-dose supply)?

Pentasa oral products and rectal products are manufactured by branded-finished-dose partners in multiple countries rather than a single global source. In practice, brand owners appoint (or license) finished-dose manufacturing sites that produce specific strengths and dosage forms: delayed-release tablets, controlled-release granules, and rectal suppositories or enemas (depending on country).

What finished-dose forms exist for Pentasa

• Oral delayed-release tablets (multiple strengths)
• Oral controlled-release granules (where marketed)
• Rectal suppositories and enemas (where marketed)

How finished-dose supply is usually structured for Pentasa

• API purchase from qualified mesalazine suppliers
• Finished-dose production at one or more validated manufacturing sites per region
• Country-specific packaging and labeling by local wholesalers or regional depots

Which companies supply mesalazine API used to make Pentasa?

Pentasa is a mesalazine product, so the key upstream input is mesalazine API (5-ASA). API suppliers for mesalazine are widely distributed globally because mesalazine is a mature, high-volume generic molecule. Finished-dose manufacturers typically source mesalazine API through:

• Direct contracts with API producers
• Intermediaries (traders/agents) with qualified supply chains
• Licensed supply relationships tied to regulatory filings

Why API sourcing matters for Pentasa

Because mesalazine is the active ingredient, supplier qualification, impurity profiles (notably related substances), and stability specs drive downstream release. Brand supply failures tend to show up as manufacturing holds at finished-dose sites rather than as direct API shortages, unless an upstream API node loses capability.

What are the key supply sites for Pentasa in Europe?

In Europe, Pentasa is sold under a brand controlled through regional subsidiaries and marketing authorizations. Finished-dose products are produced under GMP and released by national or EU-authorized quality entities. The supply footprint generally includes:

• EU finished-dose manufacturing sites for oral and rectal formats
• Parallel packaging operations in distribution hubs per member state

What regulatory registrations indicate about suppliers

For multi-country brands like Pentasa, the manufacturer-of-finished-product listed on each national authorization often changes by:

• dosage form
• strength
• market author
• packaging location

That naming typically reflects the actual GMP release site for each country-specific label.

What are the Pentasa supplier options in the US (FDA commercialization footprint)?

Pentasa is marketed in the US and is associated with FDA-listed product manufacturing and labeling. For US supply, upstream API suppliers and finished-dose manufacturers may differ from the EU due to:

• filing ownership and manufacturing site strategy
• cost and lead-time optimization
• reliance on established contract manufacturers for mature oral and rectal generics-like chemistries

What FDA listings show about supplier structure

The US “listed drug” manufacturing and labeling are reflected in FDA’s dataset through:

• applicant/labeler
• manufacturing sites
• dosage form identifiers

Those listings are the best direct proxy for finished-dose supply in the US market.

How do Pentasa suppliers differ by dosage form (tablets vs granules vs rectal)?

Supplier specialization is common because dosage forms require distinct unit operations:

• Oral delayed-release tablets: tablet core compression plus delayed-release coat, stability controls
• Oral granules: granulation, coating or matrix design, controlled release verification
• Rectal: different filling systems and device assembly, stricter sterility or microbial limits depending on product type

As a result, finished-dose suppliers for rectal formulations can differ from those for tablets even if they share the same mesalazine API.

What patent and exclusivity protections affect supplier substitution for Pentasa?

Even though the molecule is mature, the supplier landscape for brand vs. competitor may still hinge on:

• formulation patents (release profile and coating)
• method-of-use patents (subset indications, dosing regimens)
• process patents (manufacturing method, impurity control)
• regulatory exclusivities tied to specific product approvals

Where a brand has enforceable formulation IP, suppliers can still manufacture the same active ingredient but may face constraints on “look-alike” product design and labeling claims.

Which companies sell generic mesalazine products that can compete with Pentasa in the same channels?

Because mesalazine is heavily genericized, the practical competitive set includes:

• generic mesalamine delayed-release tablet manufacturers
• generic mesalamine extended-release products
• rectal mesalamine alternatives (suppositories/enemas)

These competitors pressure supplier negotiations for API and finished-dose capacity. However, direct “supplier of Pentasa” does not equal “supplier to generics.” The more reliable mapping is from:

• finished-dose manufacturing sites listed on each labeled product
• API supply qualification documents and supplier qualification practices at the contract manufacturer level

What is the Orange Book status of Pentasa in the US and how does it impact supplier sourcing?

If a product is listed in the FDA Orange Book, the patent and exclusivity fields shape generic entry timing. That affects:

• whether contract manufacturing sites seek brand-adjacent capacity
• whether API allocation prioritizes brand supply
• whether alternate finished-dose designs are needed for generic approvals

Pentasa’s Orange Book status is typically used to time generic substitution and to manage risk in licensing and supply contracts.

How strong is the supplier supply chain risk for Pentasa (single-source vs multi-source)?

Pentasa supply risk usually depends on whether its finished-dose production is multi-site and whether its mesalazine API is contracted from more than one qualified source.

Indicators of multi-source supply

• Multiple finished-dose manufacturing sites listed across countries
• Multiple labeler/packager combinations
• History of production in different GMP sites over successive years

Indicators of single-source exposure

• Consistent reliance on one manufacturer-of-record across multiple markets
• Lack of alternative GMP sites in filings
• Recent production changes tied to manufacturing investigations

What licensing and contract supply patterns exist for Pentasa?

Branded pharmaceutical products with mature APIs often rely on:

• contract manufacturing organizations (CMOs) with multi-product capacity
• licensed production where local subsidiaries hold marketing authorizations
• packaging and distribution contracts per region

Those patterns allow the brand to keep supply stable while shifting GMP capacity.

Pentasa supplier landscape summary by product type

Pentasa product type	What’s sourced upstream	What’s typically “supplier” downstream	Main risk point
Oral delayed-release tablets	Mesalazine API plus excipients for delayed-release coat	Contract/tablet GMP site + packaging	Coat process and dissolution specs
Oral controlled-release granules	Mesalazine API plus granulation/coating system	Granulation line GMP site + secondary packaging	Granule uniformity and release profile
Rectal suppositories/enemas	Mesalazine API plus rectal base	Rectal filling/assembly GMP site	Microbial limits and device integration

Key Takeaways

• Pentasa supply is best mapped as two-layer sourcing: mesalazine API upstream and finished-dose manufacturing downstream.
• Finished-dose suppliers usually vary by dosage form (oral vs rectal) and by country packaging/labeling requirements.
• Regulatory listings and product authorization records are the most direct evidence of which GMP sites supply specific Pentasa presentations.
• Mesalazine API is widely sourced globally, so supplier risk typically concentrates in finished-dose GMP capacity and release rather than API availability alone.

FAQs

1. Which GMP sites are listed as the manufacturer for Pentasa tablets in my country?
2. Are mesalazine API suppliers for Pentasa the same as those used for generic mesalamine delayed-release products?
3. Does Pentasa rectal supply rely on different manufacturers than oral Pentasa?
4. What Orange Book patents for Pentasa control generic substitution timing in the US?
5. How do settlement agreements in mesalamine patent litigations affect supplier and labeling strategy for competing products?

References

1. FDA. Orange Book: Approved Drug Products With Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. (Accessed 2026-05-31).
2. FDA. Drug Labeling and Registration (Drugs@FDA and related product listing datasets). U.S. Food and Drug Administration. (Accessed 2026-05-31).