Suppliers and packagers for ROFLUMILAST

ROFLUMILAST

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	ROFLUMILAST	roflumilast	TABLET;ORAL	212490	ANDA	Golden State Medical Supply, Inc.	51407-975-90	90 TABLET in 1 BOTTLE (51407-975-90)	2023-04-18
Alkem Labs Ltd	ROFLUMILAST	roflumilast	TABLET;ORAL	212490	ANDA	Ascend Laboratories, LLC	67877-480-05	500 TABLET in 1 BOTTLE (67877-480-05)	2025-03-14
Alkem Labs Ltd	ROFLUMILAST	roflumilast	TABLET;ORAL	212490	ANDA	Ascend Laboratories, LLC	67877-480-30	30 TABLET in 1 BOTTLE (67877-480-30)	2025-03-14
Alkem Labs Ltd	ROFLUMILAST	roflumilast	TABLET;ORAL	212490	ANDA	Ascend Laboratories, LLC	67877-480-33	1 BLISTER PACK in 1 CARTON (67877-480-33) / 10 TABLET in 1 BLISTER PACK	2025-03-14

Suppliers and packagers for ROFLUMILAST

Last updated: May 24, 2026

Roflumilast Suppliers 2026: API, Intermediates, and Finished Dosage Manufacturers by Region

Roflumilast’s supply chain splits into (1) roflumilast API and key intermediates (small-molecule synthesis) and (2) finished-dose tablets sourced through contract manufacturers for brand and authorized generics. Supplier identification depends on the specific commercial product (brand vs generic), the dosage strength (typically 250 mcg or 500 mcg depending on market), and the registered manufacturing sites listed in regulatory filings and drug product registries.

What follows is the actionable supplier map used in pharma procurement and IP diligence:

• API/intermediate suppliers that produce roflumilast synthesis building blocks and final API for third-party drug makers.
• Drug product manufacturers (tablets) that package roflumilast under marketing authorizations.
• Region coverage aligned to typical sourcing hubs for European, MENA, and US-distributed generics.

No complete, end-to-end, regulator-grade supplier list can be produced without product-specific regulatory data (market authorization holders, strength-specific presentations, and registered manufacturing sites).