Suppliers and packagers for generic pharmaceutical drug: entacapone

entacapone

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Orion Pharma	COMTAN	entacapone	TABLET;ORAL	020796	NDA AUTHORIZED GENERIC	Sandoz Inc	0781-5578-01	100 TABLET, FILM COATED in 1 BOTTLE (0781-5578-01)	2014-06-04
Orion Pharma	COMTAN	entacapone	TABLET;ORAL	020796	NDA AUTHORIZED GENERIC	Sun Pharmaceutical Industries, Inc.	47335-007-88	100 TABLET, FILM COATED in 1 BOTTLE (47335-007-88)	2013-04-01
Orion Pharma	COMTAN	entacapone	TABLET;ORAL	020796	NDA AUTHORIZED GENERIC	Aphena Pharma Solutions - Tennessee, LLC	71610-247-83	3600 TABLET, FILM COATED in 1 BOTTLE (71610-247-83)	2014-06-04
Ajanta Pharma Ltd	ENTACAPONE	entacapone	TABLET;ORAL	205792	ANDA	Ajanta Pharma USA Inc.	27241-049-10	100 TABLET in 1 BOTTLE (27241-049-10)	2017-08-31
Alembic	ENTACAPONE	entacapone	TABLET;ORAL	212601	ANDA	Alembic Pharmaceuticals Limited	46708-478-31	100 TABLET, FILM COATED in 1 BOTTLE (46708-478-31)	2022-01-06

Suppliers and packagers for generic pharmaceutical drug: entacapone

Last updated: April 23, 2026

ENTACAPONE: Who Supplies the Active Ingredient and Key Intermediates?

Answer: Insufficient information is available to produce a complete, accurate, and business-actionable list of suppliers for entacapone (active pharmaceutical ingredient) and/or its critical intermediates.

Are there confirmed entacapone API suppliers by name?

No supplier names are provided in the available material, and no source text is included to validate specific companies, product grades, launch status, DMF/CEP coverage, or approved supply arrangements.

Can reliable supplier lists be built from regulatory identifiers (DMF/CEP) here?

No. The necessary regulatory identifiers (e.g., US DMF numbers, CEP holders, or dossier references) are not included, so a verified supplier mapping cannot be constructed.

Can procurement-ready details (site, grade, specs, lead times) be listed?

No. No specifications or procurement-grade data (particle size range, polymorph form, assay limits, residual solvent limits, impurity set, control strategy, GMP site, or documentation scope) are provided.

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Key Takeaways

• A supplier list for entacapone cannot be produced from the information provided.
• No verified API or intermediate supplier names, dossier identifiers, or procurement specs are present to support an accurate market map.
• Without confirmed regulatory or product documentation, any supplier names would be speculative.

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FAQs

1. What do pharmaceutical buyers use to confirm entacapone API suppliers?
   Approved regulatory dossier identifiers (e.g., DMF references, CEPs) and GMP-manufacturing site documentation tied to the API.

2. Is entacapone usually sourced as a finished API or via intermediates?
   Buyers typically source the finished API (entacapone) under GMP, while intermediate sourcing is handled for manufacturing resilience.

3. What documentation is required to qualify an entacapone supplier?
   GMP certificate for the manufacturing site, CoA with controlled impurity profile, validated test methods, and regulatory dossier linkage.

4. Do polymorph and impurity profile matter for entacapone?
   Yes. Solid-state form controls and impurity specifications drive regulatory acceptance and batch-to-batch consistency.

5. Where can supplier coverage be verified in practice?
   Through regulatory filings and dossier records referenced by procurement-grade submissions and quality agreements.

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References

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