Suppliers and packagers for RASAGILINE MESYLATE

RASAGILINE MESYLATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alkem Labs Ltd	RASAGILINE MESYLATE	rasagiline mesylate	TABLET;ORAL	201889	ANDA	NorthStar RxLLC	16714-770-01	30 TABLET in 1 BOTTLE (16714-770-01)	2018-04-17
Alkem Labs Ltd	RASAGILINE MESYLATE	rasagiline mesylate	TABLET;ORAL	201889	ANDA	NorthStar RxLLC	16714-771-01	30 TABLET in 1 BOTTLE (16714-771-01)	2018-04-17
Alkem Labs Ltd	RASAGILINE MESYLATE	rasagiline mesylate	TABLET;ORAL	201889	ANDA	Ascend Laboratories, LLC	67877-259-30	30 TABLET in 1 BOTTLE (67877-259-30)	2017-10-30
Alkem Labs Ltd	RASAGILINE MESYLATE	rasagiline mesylate	TABLET;ORAL	201889	ANDA	Ascend Laboratories, LLC	67877-260-30	30 TABLET in 1 BOTTLE (67877-260-30)	2017-10-30
Carnegie	RASAGILINE MESYLATE	rasagiline mesylate	TABLET;ORAL	201942	ANDA	Golden State Medical Supply, Inc.	51407-008-30	30 TABLET in 1 BOTTLE (51407-008-30)	2021-11-18

Suppliers and packagers for RASAGILINE MESYLATE

Last updated: April 25, 2026

Rasagiline Mesylate: Who Supplies the API and How It Maps to Patent-Usable Sources

Rasagiline mesylate is an API sold through a mix of (1) branded and generic manufacturers that hold registrations in major markets and (2) chemical/API intermediates and custom synthesis suppliers. For patent and procurement planning, the practical supplier universe splits into API producers and intermediate/custom-synthesis vendors that can qualify through ANDA/DMF pathways.

What is rasagiline mesylate used as in drug development and manufacturing?

Rasagiline mesylate is the mesylate salt form of rasagiline (a selective monoamine oxidase B inhibitor). In drug development, rasagiline mesylate is the API form targeted by regulatory filings and commercial supply agreements because it standardizes:

• Salt specifications (polymorph and hydrate control requirements typically tied to the salt form)
• Assay and impurity profiles aligned with global quality systems
• Formulation compatibility in oral solid and dose-unit manufacture

This matters for sourcing because the patent-usable supply question is not only “who makes rasagiline” but “who makes rasagiline mesylate with DMF-grade controls” and what documentation they support for regulatory submissions.

Which supplier types dominate rasagiline mesylate supply?

Market supply typically comes from four categories:

1. API manufacturers with direct regulatory filings (DMF/CEP)
   These suppliers support dossier-level traceability: route disclosure, impurity reporting, and stability data.

2. Generic drug manufacturers’ captive API sourcing
   Some companies produce API internally and sell only via their own commercial product lines.

3. Intermediates and custom synthesis providers
   They supply key intermediates or run contract manufacturing for the final API conversion to mesylate, often under NDA and quality agreements.

4. Chemical trading houses / distributors
   They repackage or source from an underlying API producer, which creates variability in regulatory documentation availability.

Which companies supply rasagiline mesylate API (and likely intermediary routes)?

The supplier landscape for rasagiline mesylate API is concentrated. The companies below are active in generic API production and/or related synthesis and have product lines that commonly include CNS and MAO-B inhibitor APIs and intermediates. These are the usual commercial sources procurement teams qualify for rasagiline mesylate.

API producers commonly used for rasagiline mesylate supply

Supplier (company)	Supply role	Typical documentation supported	What they are used for in practice
Teva API / Teva Group	API producer (often via affiliates)	DMF/registration support for commercial APIs	Supplying high-volume generics and authorized product lines
Accord / Sandoz / Mylan lineage firms (generic API network)	API + toll manufacturing ecosystem	DMF pathways vary by market; quality packs provided	Procurement for ANDA/EMEA generics workflows
Cipla	API and generics supply chain	Regulatory dossier support for API where applicable	Commercial generic supply and controlled API transfers
Hetero (and Hetero API network)	API manufacturer	DMF/CEP-style quality support in many portfolios	Tailored quality and scale for regulated markets
Dr. Reddy’s Laboratories	API producer	API dossier and quality documentation	Long-term supply for CNS-heavy portfolios
Sun Pharma / Sun API ecosystem	API producer	Quality and regulatory support for API lines	Scale procurement and market-specific compliance
Aurobindo Pharma / API network	API producer	Dossier support for major markets	Multiple generic product lines with API sharing logic
Lupin (and Lupin API network)	API producer	Dossier support where filed	API supply tied to generic development cycles

Custom synthesis and intermediate suppliers that support rasagiline mesylate manufacture

These vendors usually sell intermediates and run custom routes rather than marketing a fully dossier-ready mesylate API to third parties. They become relevant when a generic developer wants route flexibility or cost reduction while still needing mesylate formation and impurity control.

Supplier type	Typical offering	Why it matters for rasagiline mesylate
Intermediates suppliers	Key backbone intermediates and protected forms	Can reduce cycle time and risk if they already handle analogous CNS chemistries
Contract research and manufacturing (CRAMS)	Toll API manufacturing, mesylate salt formation	Enables “finish-to-spec” conversions under agreed controls
Chemical trading/distribution houses	Sourcing from underlying API producers	Fast entry into procurement but requires dossier verification during qualification

How do you narrow supplier choices to “regulatory-usable” sources?

For rasagiline mesylate, “supplier” must be evaluated on dossier usability, not just chemical availability. The qualification shortlist should be constrained to suppliers that can provide:

• API specification package
  • assay, water content
  • related substances/impurity list
  • residual solvents
  • particle size where applicable
• Salt form confirmation
  • mesylate identity, salt form stability during storage
  • impurity behavior after salt formation
• Regulatory dossier support
  • DMF access (or a right-to-reference arrangement) where required
  • CEP-style documentation for EMEA pathways
• GxP manufacturing controls
  • cGMP certificates for API manufacturing sites
  • audit history and change notification practices

A “chemical-only” supplier can deliver material but often fails the regulatory usability test when the DMF/CEP pathway is mandatory for rapid generic launch.

What sourcing strategy reduces patent and commercial-risk exposure?

Procurement and R&D sourcing for rasagiline mesylate should be structured around two levers: route control and documentation.

1. Dual-source qualification
   • Qualify at least two API suppliers (or one API supplier plus one toll-synthesis partner) against the same specification targets.
2. Route-consistency checks
   • Ensure suppliers can show impurity signatures aligned with the intended route class.
3. Change control alignment
   • Verify commitments to notify on route changes, mesylate formation changes, or impurity re-specifications.
4. Regulatory documentation ownership
   • Ensure dossier reference rights or document transfer terms are secured before entering commercialization timelines.

How does rasagiline mesylate supplier selection intersect with patent strategy?

From a patent-work standpoint, suppliers matter in three ways:

• Manufacturing route disclosure: DMFs and site documentation often disclose route elements that can collide with process claims.
• Impurity profile matching: Some process claims effectively carve out impurity sets; sourcing that yields a different impurity signature can change non-infringement analysis.
• Salt formation and workup steps: “Mesylate conversion” can be part of downstream process claim coverage in some families, depending on claim wording and scope.

Therefore, supplier qualification should be tied to the intended freedom-to-operate workstream: route class, salt formation conditions, and final purification steps.

Practical supplier shortlisting template (for rasagiline mesylate)

Use this as the qualification filter when building your supplier list:

Gate	Requirement	Output
1	Supplier provides rasagiline mesylate API with full COA and specification	Approved specification baseline
2	Supplier supports impurity list alignment and residual solvent limits	Ability to match ANDA/registration standards
3	Supplier can provide dossier linkage (DMF/CEP or right-to-reference)	Regulatory-use readiness
4	Supplier supports mesylate identity and stability checks	Salt form defensibility
5	Supplier supports audit and change notification	Operational continuity

Key supplier mapping: which vendors best fit each procurement scenario

Procurement scenario	Supplier profile that fits best
Fastest regulatory-usable supply	API producers with DMF/CEP support
Cost-optimized scaling after bioequivalence	API producers with multiple campaigns and stable impurity profiles
Route-risk reduction	Dual-source API producers or API + toll-synthesis with documented salt formation control
Development-stage experiments	CRAMS/custom synthesis and intermediate suppliers that can run small-to-mid scale then transition to cGMP

Key Takeaways

• Rasagiline mesylate supply splits into API producers with regulatory documentation and custom synthesis/intermediate suppliers that require qualification for dossier usability.
• For patent- and launch-critical work, the deciding criterion is not availability but spec and dossier linkage: impurity profile, mesylate identity, stability, and DMF/CEP access.
• Build a dual-source qualification plan and align supplier documentation with the intended freedom-to-operate and regulatory path.

FAQs

1) What supplier documentation is most important for rasagiline mesylate?

The most important documents are the API specification package, full COA with impurity breakdown, and regulatory dossier linkage (DMF/CEP or right-to-reference) plus mesylate identity and stability support.

2) Do distributors qualify as rasagiline mesylate suppliers for regulatory submissions?

Distributors can source the material, but regulatory usability depends on whether the underlying API producer provides dossier-level documentation and change control terms.

3) What is the biggest technical supplier risk for rasagiline mesylate?

The biggest technical risk is salt form control and impurity profile drift during mesylate formation and final purification, which can break spec targets or complicate patent analysis.

4) How many suppliers should be qualified for rasagiline mesylate?

A procurement-ready plan typically qualifies two sources to reduce lead-time and change-control risk.

5) How does supplier choice affect freedom-to-operate analysis?

Supplier documentation can expose route and workup details that align with process claims, while differing impurity signatures and salt formation steps can change infringement assessments.

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References

[1] U.S. Food and Drug Administration. Drug Development and Drug Approval Process. FDA (accessed 2026-04-25). https://www.fda.gov/drugs/development-approval-process-drugs
[2] European Medicines Agency. Scientific Guidelines on quality of pharmaceutical substances and products. EMA (accessed 2026-04-25). https://www.ema.europa.eu/en/industry/quality/quality-guidelines
[3] FDA. Drug Master Files (DMF). U.S. FDA (accessed 2026-04-25). https://www.fda.gov/drugs/drug-master-files-dmfs