Suppliers and packagers for generic pharmaceutical drug: homatropine methylbromide; hydrocodone bitartrate

homatropine methylbromide; hydrocodone bitartrate

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Genus	HYCODAN	homatropine methylbromide; hydrocodone bitartrate	SYRUP;ORAL	005213	NDA AUTHORIZED GENERIC	PAI Holdings, LLC dba PAI Pharma	0121-1036-40	4 TRAY in 1 CASE (0121-1036-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-1036-05)	2024-08-05
Genus	HYCODAN	homatropine methylbromide; hydrocodone bitartrate	SYRUP;ORAL	005213	NDA AUTHORIZED GENERIC	Genus Lifesciences Inc.	64950-206-03	30 TABLET in 1 BOTTLE, PLASTIC (64950-206-03)	2022-08-10
Genus	HYCODAN	homatropine methylbromide; hydrocodone bitartrate	SYRUP;ORAL	005213	NDA AUTHORIZED GENERIC	Genus Lifesciences Inc.	64950-206-10	100 TABLET in 1 BOTTLE, PLASTIC (64950-206-10)	2022-08-10
Genus	HYCODAN	homatropine methylbromide; hydrocodone bitartrate	SYRUP;ORAL	005213	NDA AUTHORIZED GENERIC	Genus Lifesciences Inc.	64950-371-47	473 mL in 1 BOTTLE (64950-371-47)	2022-08-10
Abhai Llc	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	homatropine methylbromide; hydrocodone bitartrate	SYRUP;ORAL	207487	ANDA	KVK-Tech, Inc.	10702-150-16	473 mL in 1 BOTTLE (10702-150-16)	2017-02-21
Actavis Mid Atlantic	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	homatropine methylbromide; hydrocodone bitartrate	SYRUP;ORAL	088017	ANDA	Actavis Pharma, Inc.	0472-1030-16	473 mL in 1 BOTTLE (0472-1030-16)	2002-09-30
Novel Labs Inc	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	homatropine methylbromide; hydrocodone bitartrate	SYRUP;ORAL	203535	ANDA	Novel Laboratories, Inc.	40032-810-05	473 mL in 1 BOTTLE (40032-810-05)	2017-02-13

Supplier Landscape for Homatropine Methylbromide and Hydrocodone Bitartrate: Key API Manufacturers, Intermediates, and Contract Manufacturing Routes

Last updated: May 26, 2026

Executive summary

• Homatropine methylbromide and hydrocodone bitartrate are both commercially available as active pharmaceutical ingredients (APIs), but supply is structurally constrained by regulatory controls (narcotics/controlled substances for hydrocodone) and by the chemistry complexity of quaternary ammonium antimuscarinics (homatropine methylbromide).
• The practical “supplier set” for each API splits into (1) API producers that can supply DMFs for US market access, (2) intermediate manufacturers that support API scale, and (3) contract development and manufacturing organizations (CDMOs) that run finished-dose or API bottlenecks.
• Hydrocodone supply is the tighter bottleneck category due to controlled-substance handling and DEA-cognizant manufacturing logistics, so multi-source qualification and redundant logistics are typically required for continuity.

No complete, reliable supplier roster can be produced from the information provided.