Is Microchem Laboratory FDA approved?

Microchem Laboratory holds 3 FDA-registered establishments across 2 countries. 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 Microchem Laboratory's drugs manufactured?

At registered sites in Italy, the United States. The FDA register lists FIORENZUOLA D'ARDA; Richardson, TX; Round Rock, TX. Registered operations: analytical testing, finished drug manufacture, particle size reduction.

Microchem Laboratory

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

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Registered sites: 3
Active NDC listings: 0
Live patents: 0
Countries: 2
Base: United States

Authorisation

Registered operations

Analytical testing2Finished drug manufacture1particle size reduction1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
MICROCHEM SRL	VIA FILIPPO TURATI 2, FIORENZUOLA D'ARDA, - 29017, Italy (ITA)	Finished drug manufacture, particle size reduction	3002807601445019862
Microchem Laboratory	990 N. Bowser, Road, Suite 800, Richardson, Texas (TX) 75081, United States (USA)	Analytical testing	3037143716121382657
Microchem Laboratory	1700 Chisholm Trail Rd, Round Rock, Texas (TX) 78681, United States (USA)	Analytical testing	3011865253088213379

Neighbours

Registered in the same town

Benuvia Operations, LLCRound Rock, TX
FluoroMed Products, L.P.Round Rock, TX

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Enquiry

Common questions

Is Microchem Laboratory FDA approved?: Microchem Laboratory holds 3 FDA-registered establishments across 2 countries. 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 Microchem Laboratory's drugs manufactured?: At registered sites in Italy, the United States. The FDA register lists FIORENZUOLA D'ARDA; Richardson, TX; Round Rock, TX. Registered operations: analytical testing, finished drug manufacture, particle size reduction.

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.