Is Laboratorio Magnachem International SRL FDA approved?

Laboratorio Magnachem International SRL holds 1 FDA-registered establishment in the Dominican Republic. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are Laboratorio Magnachem International SRL's drugs manufactured?

The FDA register lists San Cristobal. Registered operations: finished drug manufacture.

What drugs does Laboratorio Magnachem International SRL make?

13 products are listed under Laboratorio Magnachem International SRL in the openFDA NDC Directory, most often as syrup; tablet, coated; granule, for solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Laboratorio Magnachem International SRL

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 1
Active NDC listings: 13
Live patents: 0
Countries: 1
Base: Dominican Republic

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Laboratorio Magnachem International SRL	Ave Jose Francisco Pena Gomez (Antigua Refineria) esq. Calle K, San Cristobal, San Cristobal 11116, Dominican Republic (DOM)	Finished drug manufacture	3003320065871446100

Catalogue

Drug listings by form and route

13 active NDC listings: 13 human otc drug. By marketing category: OTC MONOGRAPH DRUG 9, OTC MONOGRAPH FINAL 3, OTC MONOGRAPH NOT FINAL 1.

Dosage form	NDCs
syrup	10
tablet, coated	2
granule, for solution	1

Route	NDCs
oral	13

Labeller name on the listing	NDCs
laboratorio magnachem international srl	13

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
BRONCOCHEM ALLERGY CONTROL	Cholpheniramine maleate-Phenylephrine HCl	syrup, oral	65131-098OTC MONOGRAPH FINAL
BRONCOCHEM COLD AND FLU CAPLETS	Acetaminophen-Dextromethorphan HBr-Phenylephrine HCl-Chlorpheniramine Maleate	tablet, coated, oral	65131-101OTC MONOGRAPH DRUG
BRONCOCHEM COLD AND FLU CAPLETS	Acetaminophen-Dextromethorphan HBr-Phenylephrine HCl-Chlorpheniramine Maleate	tablet, coated, oral	65131-111OTC MONOGRAPH DRUG
BRONCOCHEM COLD AND FLU TEA	ACETAMINOPHEN-PHENYLEPHRINE HYDROCHLORIDE-CHLORPHENIRAMINE MALEATE	granule, for solution, oral	65131-097OTC MONOGRAPH DRUG
BRONCOCHEM EXPECTORANT II	ACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBr-GUAIFENESIN-PHENYLEPHRINE HCl	syrup, oral	65131-011OTC MONOGRAPH DRUG
BRONCOCHEM EXPECTORANT II	ACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBr-GUAIFENESIN-PHENYLEPHRINE HCl	syrup, oral	65131-116OTC MONOGRAPH NOT FINAL
BRONCOCHEM KIDS COLD AND FLU	ACETAMINOPHEN-PHENYLEPHRINE HCl-GUAIFENESIN	syrup, oral	65131-054OTC MONOGRAPH FINAL
BRONCOCHEM KIDS COLD AND FLU	ACETAMINOPHEN-PHENYLEPHRINE HCl-GUAIFENESIN	syrup, oral	65131-109OTC MONOGRAPH DRUG
BRONCOCHEM MAXIMUM COUGH	DEXTROMETHORPHAN HBr-GYAIFENESIN	syrup, oral	65131-091OTC MONOGRAPH FINAL
BRONCOCHEM MAXIMUM COUGH	DEXTROMETHORPHAN HBr-GYAIFENESIN	syrup, oral	65131-100OTC MONOGRAPH DRUG
BRONCOCHEM MAXIMUM COUGH KIDS	DEXTROMETHORPHAN HBr-GUAIFENESIN	syrup, oral	65131-180OTC MONOGRAPH DRUG
BRONCOCHEM MAXIMUM COUGH NIGHT	DEXTROMETHORPHAN HBR-PYRILAMINE MALEATE	syrup, oral	65131-035OTC MONOGRAPH DRUG
BRONCOCHEM MAXIMUM COUGH NIGHT	DEXTROMETHORPHAN HBR-PYRILAMINE MALEATE	syrup, oral	65131-110OTC MONOGRAPH DRUG

Compare

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BOE Dominicana SRL1 site · 1 NDC

Enquiry

Common questions

Is Laboratorio Magnachem International SRL FDA approved?: Laboratorio Magnachem International SRL holds 1 FDA-registered establishment in the Dominican Republic. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Laboratorio Magnachem International SRL's drugs manufactured?: The FDA register lists San Cristobal. Registered operations: finished drug manufacture.
What drugs does Laboratorio Magnachem International SRL make?: 13 products are listed under Laboratorio Magnachem International SRL in the openFDA NDC Directory, most often as syrup; tablet, coated; granule, for solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.