Labeler · US market

NEWCHEM SPA

NEWCHEM SPA is a US drug labeler with US FDA registrations covering 31 drug concepts (31 currently active) across 33 packages. It is currently the only active US supplier of 7 drugs. The company files with FDA under 2 name variants, merged into this profile.

Also files as: Newchem S.p.A.

ACTIVE — US

openFDA · updated weekly

Labeler codes24002

Active drugs31

Registrations33 active / 33

Packages33

Sole supplier of7 drugs

Portfolio31 drugs · US

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

Drug	Type	NDCs	Packages	Status
Drospirenone powder	other	2	2	SUPPLYING
Triamcinolone Acetonide Micronized powder	other	2	2	SUPPLYING
Dexamethasone Sodium Phosphate powder	other	1	1	SUPPLYING
Bimatoprost powder	other	1	1	SUPPLYING
Ciclesonide powder	other	1	1	SUPPLYING
Fluticasone Propionate Micronized powder	other	1	1	SUPPLYING
Travoprost oil	other	1	1	SUPPLYING
Latanoprost oil	other	1	1	SUPPLYING
Hydrocortisone Butyrate Micronized powder	other	1	1	SUPPLYING
Triamcinolone Micronized powder	other	1	1	SUPPLYING
Hydrocortisone Acetate powder	other	1	1	SUPPLYING
Methylprednisolone Hemisuccinate powder	other	1	1	SUPPLYING
Betamethasone Acetate Micronized powder	other	1	1	SUPPLYING
Prednicarbate powder	other	1	1	SUPPLYING
Budesonide Micronized powder	other	1	1	SUPPLYING
Nomegestrol Acetate powder	other	1	1	SUPPLYING
Betamethasone Sodium Phosphate powder	other	1	1	SUPPLYING
Betamethasone Dipropionate Micronized powder	other	1	1	SUPPLYING
Desonide Micronized powder	other	1	1	SUPPLYING
Prednisolone Sodium Phosphate powder	other	1	1	SUPPLYING
Clobetasol Propionate Micronized powder	other	1	1	SUPPLYING
Dienogest powder	other	1	1	SUPPLYING
Hydrocortisone Hydrogen Succinate powder	other	1	1	SUPPLYING
Beraprost Sodium powder	other	1	1	SUPPLYING
Mometasone Furoate Micronized powder	other	1	1	SUPPLYING
Myristil Gamma Picolinium Chloride powder	other	1	1	SUPPLYING
Fluorometholone Micronized powder	other	1	1	SUPPLYING
Methylprednisolone Acetate Micronized powder	other	1	1	SUPPLYING
Tibolone powder	other	1	1	SUPPLYING
Betamethasone Valerate Micronized powder	other	1	1	SUPPLYING
Deflazacort powder	other	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 codes24002
Filing names2
Drugs (active)31
Drugs (all time)31
US registrations33
Packages33

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.