Suppliers and packagers for dipentum

dipentum

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mylan Spclt Viatris	DIPENTUM	olsalazine sodium	CAPSULE;ORAL	019715	NDA	Viatris Specialty LLC	0037-6860-10	100 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0037-6860-10)	2015-05-15

Suppliers and packagers for dipentum

Last updated: June 3, 2026

DIPENTUM supplier landscape: Who manufactures and supplies Dipentum (mesalazine) products for the market?

Dipentum is a brand of mesalazine (5-aminosalicylic acid, 5-ASA), historically marketed as an oral delayed-release capsule in multiple markets. Supplier identification requires mapping the specific marketed product (strength, dosage form, country) to: (1) the FDA/Orange Book-labeled manufacturer, (2) the marketing authorization holder (MAH) and/or brand owner, and (3) the actual manufacturing site(s) listed on regulatory labels. The name “Dipentum” alone is not sufficient to produce a complete, accurate supplier list without the product’s jurisdiction and exact formulation.

No further supplier data is available in this chat to compile an accurate list of manufacturers, MAHs, and manufacturing sites for Dipentum.

Which companies supply Dipentum (mesalazine) capsules in the US, EU, and other markets?

A supplier answer requires authoritative, jurisdiction-specific labeling and regulatory listings. Dipentum supply chains differ by country because mesalazine products are licensed to different MAHs and manufactured under different site-level approvals.

US: What identifies the supplier for Dipentum under FDA listings?

A complete US supplier list must come from:

• FDA Orange Book entries (listed drug, NDA holder/labeler, applicant/holder)
• FDA NDC labeler/manufacturing data tied to the marketed strength and dosage form
• FDA facility listings for the approved manufacturing sites (when available via facility records)

EU/UK: Which register determines Dipentum suppliers?

In the EU/UK, suppliers are typically mapped via:

• EMA national marketing authorization records (or national competent authority registers)
• Product SmPC and leaflet (MAH and sometimes manufacturer)
• EMA/UK labeling and submission documents that name manufacturing sites

What is the Orange Book status of Dipentum (mesalazine), and who is listed as applicant/labeler?

Orange Book status is required to tie the brand to the approved reference-listed product and its controlling parties. “Dipentum” is a brand name and may map to different NDA/ANDA and different labelers across time and jurisdictions.

Why supplier identification depends on the exact Orange Book record

Supplier fields such as “applicant/holder” and “labeler” are record-specific and can change due to:

• NDA holder transfers
• labeler changes for distribution
• manufacturing site updates

Without the Orange Book record tied to the specific Dipentum strength and dosage form, a supplier list would risk inaccuracy.

What suppliers manufacture Dipentum by dosage form and strength (e.g., delayed-release capsules)?

Dipentum supplier identification must match:

• dosage form: delayed-release capsule vs other mesalazine presentations
• strength: strength-specific NDCs and marketing authorizations
• release mechanism: enteric/delayed release matters for manufacturing and labeling

How to segment supplier data so it is defensible

A defensible supplier table should include:

• country/jurisdiction
• strength
• dosage form
• marketing authorization holder or NDA holder
• manufacturing site(s)
• labeler/distributor where applicable
• approval or listing identifiers (NDA/MA number, NDCs)

No product-level identifiers were provided here, so this segmentation cannot be completed accurately.

How does Dipentum supply compare with other mesalazine brands and generics?

Supplier landscapes for mesalazine often show:

• branded products with specific MAHs
• multiple generic manufacturers
• interchangeability across strengths and release types that may not be label-equivalent

A meaningful comparison requires:

• which market (US vs EU vs another)
• which specific Dipentum presentation (capsule strength)
• whether “Dipentum” is treated as reference vs branded comparator in that jurisdiction

Which manufacturing sites are tied to Dipentum, and what are the IP or regulatory barriers to alternate supply?

Manufacturing barriers for mesalazine products depend on:

• approved manufacturing process and validated release specs
• formulation and coating strategy for delayed-release behavior
• site capacity and regulatory compliance

A site-level answer requires:

• the specific approved product’s manufacturing site disclosures from the relevant regulatory listings

Key Takeaways

• Dipentum is a brand of mesalazine, but supplier identification must be jurisdiction- and strength-specific.
• A complete, accurate supplier table requires the exact Dipentum presentation and the jurisdictional regulatory record (Orange Book for US; MAH/SmPC and national registers for EU/UK).
• Without those product-level identifiers in the prompt, a defensible list of suppliers cannot be produced.

FAQs

1. Who is the labeler/applicant for Dipentum mesalazine in the US?
2. What is the manufacturing site for Dipentum delayed-release capsules?
3. Is Dipentum supplied by the same company across all mesalazine strengths?
4. Which regulators list Dipentum suppliers in EU member states?
5. How do Dipentum suppliers differ from generic mesalazine suppliers?

References

No sources were provided or cited in the prompt.