Suppliers and packagers for generic pharmaceutical drug: OLSALAZINE SODIUM

OLSALAZINE SODIUM

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 generic pharmaceutical drug: OLSALAZINE SODIUM

Last updated: June 3, 2026

Olsalazine Sodium Suppliers: Who Manufactures the API and How to Source for Generics and Formulations

Olsalazine sodium sourcing breaks into two supply chains: (1) API production of olsalazine sodium (or a salt-form of the same active) and (2) finished-dose/ingredient supply for capsules and tablets where companies purchase API and validate compounding, stability, and regulatory specs. There is not enough supplier- and lot-specific information in the provided input to produce a complete, accurate supplier map (company names, capacities, regulatory status, quality system certs, and documented product listings) for business or litigation use.

Which companies supply olsalazine sodium API?

The API supplier set is not determinable from the provided information. A credible supplier list must be grounded in verifiable product documentation such as:

• Drug Master File (DMF) references for olsalazine sodium (or relevant salt forms)
• FDA Establishment Registration and Drug Listing tie-outs
• CEP dossiers and manufacturer listings by regulatory territories
• Public procurement listings tied to olsalazine sodium grade and specifications

No supplier entities are provided in the request, so a factual supplier-company answer cannot be generated.

What API grades and specifications are typically offered for olsalazine sodium?

A complete spec-and-grade supplier profile requires named suppliers and their COA/spec sheet details (assay range, particle size, polymorph/solid state form if relevant, residual solvents, genotox impurity controls). None are included in the prompt.

Does olsalazine sodium come from multiple chemical supply routes?

A route-by-route supplier map requires vendor technical dossiers (synthetic route, intermediate sourcing, impurity strategy) linked to named manufacturers. No such information is provided.

Are there olsalazine sodium suppliers in the US, EU, or India?

A geographic supplier list must be anchored to public regulatory listings (FDA registrations for US manufacture, EDQM/EMA CEP holders for EU, and national drug regulator registrations for India). No regional supplier dataset is provided.

What is the Orange Book status of olsalazine sodium and how does it affect sourcing?

Orange Book status is drug-product and NDC-specific. No NDC, sponsor, or listed drug reference is provided, so an Orange Book-derived sourcing and exclusivity readout cannot be produced accurately.

Which finished-dose manufacturers source olsalazine sodium from contract suppliers?

Finished-dose manufacturers usually buy API from contract manufacturers or hold their own API supply via vertically integrated sites. Determining which companies do what requires product label sourcing disclosures or regulatory facility mappings tied to named firms. The prompt does not include any manufacturer names, NDCs, or label details.

What generic entry risks exist for olsalazine sodium products?

Paragraph IV risk analysis requires:

• Listed drug(s) tied to olsalazine sodium
• Orange Book patents and expiration dates
• Whether ANDAs exist and their challenge status No such patent or ANDA context is provided.

What patents protect olsalazine sodium formulations and how does that affect supplier qualification?

A formulation patent and process IP review must be anchored to:

• Patent numbers listed for the relevant listed drug(s)
• Dosage form (capsule, tablet, delayed release if applicable)
• Process claims for granulation, coating, stabilization, and salt form conversion No patent numbers or listed product identity are provided.

How strong is the patent estate for olsalazine sodium and what does that mean for contract manufacturing?

Patent strength metrics require:

• Count of active composition-of-matter, method-of-use, formulation, and process patents
• Claim scope relevant to generic manufacturing and formulation equivalence No patent estate data is included in the prompt.

What regulatory submissions reference olsalazine sodium suppliers (DMFs/CEP/ASMF)?

Supplier identification from DMF/ASMF/CEP filings requires the ASMF/DMF holder names or dossier references in regulatory databases. Those inputs are not provided.

How to qualify a new olsalazine sodium supplier for GMP and pharmacovigilance

Qualification requires documented GMP compliance and quality agreements:

• Site GMP inspections and remediation history
• Compliance with ICH Q3A/Q3B (impurities), Q7 (API GMP), Q9 (QMS), and Q11 (development of drug substances)
• Incoming material testing and change control This is not a supplier list, and it cannot substitute for vendor identification.

Key Takeaways

• A supplier-company map for olsalazine sodium cannot be produced from the provided request without vendor- or regulatory-anchored identifiers.
• Any actionable sourcing plan must begin with named API suppliers (or DMF/CEP holders) and tie them to validated olsalazine sodium specifications, regulatory listings, and facility GMP status.

FAQs

1. How do I identify the olsalazine sodium API DMF holders used in ANDAs?
2. Which regulatory dossiers typically list olsalazine sodium manufacturing sites (ASMF vs CEP vs DMF)?
3. What quality attributes matter most for olsalazine sodium API release testing?
4. Do olsalazine sodium formulations require special solid-state or stability testing for generics?
5. How do supplier changes trigger CMC comparability studies for olsalazine sodium products?

References

(No sources were provided or can be cited from the input.)