Labeler · US market

LABORATORIO MAGNACHEM INTERNATIONAL SRL

LABORATORIO MAGNACHEM INTERNATIONAL SRL is a US drug labeler with US FDA registrations covering 9 drug concepts (9 currently active) across 15 packages. It is currently the only active US supplier of 8 drugs. The company files with FDA under 2 name variants, merged into this profile.

Also files as: LABORATORIO MAGANCEHM INTERNATIONAL SRL

ACTIVE — US

openFDA · updated weekly

Labeler codes65131

Active drugs9

Registrations14 active / 14

Packages15

Sole supplier of8 drugs

Portfolio9 drugs · US

Every drug concept this labeler has US registrations for, by package count.

Drug	Type	NDCs	Packages	Status
Acetaminophen-Phenylephrine Hydrochloride-Chlorpheniramine Maleate granule, for solution	otc	1	2	SUPPLYING
Dextromethorphan Hbr-Gyaifenesin syrup	otc	2	2	SUPPLYING
Acetaminophen-Chlorpheniramine Maleate-Dextromethorphan Hbr-Guaifenesin-Phenylephrine Hcl syrup	otc	2	2	SUPPLYING
Acetaminophen-Phenylephrine Hcl-Guaifenesin syrup	otc	2	2	SUPPLYING
Dextromethorphan Hbr-Pyrilamine Maleate syrup	otc	2	2	SUPPLYING
Acetaminophen-Dextromethorphan Hbr-Phenylephrine Hcl-Chlorpheniramine Maleate tablet, coated	otc	2	2	SUPPLYING
Dextromethorphan Hbr-Guaifenesin syrup	otc	1	1	SUPPLYING
Chlorpheniramine Maleate-Dextromethrophan Hbr syrup	otc	1	1	SUPPLYING
Cholpheniramine Maleate-Phenylephrine Hcl syrup	otc	1	1	SUPPLYING

Sole US supplier

Drugs where this labeler is currently the only active US supplier — a single point of failure if it exits.

At a glance

TypeLabeler
Labeler codes65131
Filing names2
Drugs (active)9
Drugs (all time)9
US registrations14
Packages15

Recent events

Shortages, recalls, and registration changes across all filing names.

Feb 16, 2024
RECALLRecall (Class II): Broncochem Cold & Tea (acetaminophen, phenylephrine, HCl, chlorpheniramine maleate), packaged in 13g sachets, 25 sachet…

Watch this company

Alerts for recalls, exits, and new registrations.

Facility locations, FDA inspections, and parent-company mapping are on the roadmap. Name variants reported to FDA under different spellings are merged into this profile (see “Also files as” above); figures cover the entity across all its filing names.