Is Mitim S.r.l. FDA approved?

Mitim S.r.l. holds 1 FDA-registered establishment in Italy. 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 Mitim S.r.l.'s drugs manufactured?

The FDA register lists Brescia. Registered operations: analytical testing, labelling, finished drug manufacture, packaging, sterilize.

What drugs does Mitim S.r.l. make?

4 products are listed under Mitim S.r.l. in the openFDA NDC Directory, most often as injection, powder, lyophilized, for solution; injection, powder, for solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Mitim S.r.l.

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

Request a quote Claim this profile

Registered sites: 1
Active NDC listings: 4
Live patents: 0
Countries: 1
Base: Italy

Authorisation

Registered operations

Analytical testing1Labelling1Finished drug manufacture1Packaging1sterilize1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Mitim S.r.l.	Via Gian Battista Cacciamali 34, Brescia, 25125, Italy (ITA)	Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize	3005746589438137085

Catalogue

Drug listings by form and route

4 active NDC listings: 4 human prescription drug. By marketing category: DRUG FOR FURTHER PROCESSING 4.

Dosage form	NDCs
injection, powder, lyophilized, for solution	3
injection, powder, for solution	1

Route	NDCs

Labeller name on the listing	NDCs
mitim s.r.l.	4

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Sulbactam for injection	injection, powder, for solution	22607-311DRUG FOR FURTHER PROCESSING
-	piperacillin sodium and tazobactam sodium	injection, powder, lyophilized, for solution	22607-012DRUG FOR FURTHER PROCESSING
-	piperacillin sodium and tazobactam sodium	injection, powder, lyophilized, for solution	22607-034DRUG FOR FURTHER PROCESSING
-	piperacillin sodium and tazobactam sodium	injection, powder, lyophilized, for solution	22607-056DRUG FOR FURTHER PROCESSING

Compare

Comparable companies in Italy

GUNA-Spa1 site · 83 NDC
CAMBREX PROFARMACO MILANO SRL1 site · 43 NDC
BSP Pharmaceuticals SpA1 site · 40 NDC
Chiesi USA, Inc.1 site · 25 NDC
Archimica S.p.A.1 site · 22 NDC
Steroid S.p.A.1 site · 13 NDC
Societa Italiana Medicinali Scandicci S.I.M.S. SrL1 site · 12 NDC
Bidachem S.p.a.1 site · 8 NDC
Cosmo SpA1 site · 4 NDC
Delpharm Milano Srl1 site · 3 NDC

Enquiry

Common questions

Is Mitim S.r.l. FDA approved?: Mitim S.r.l. holds 1 FDA-registered establishment in Italy. 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 Mitim S.r.l.'s drugs manufactured?: The FDA register lists Brescia. Registered operations: analytical testing, labelling, finished drug manufacture, packaging, sterilize.
What drugs does Mitim S.r.l. make?: 4 products are listed under Mitim S.r.l. in the openFDA NDC Directory, most often as injection, powder, lyophilized, for solution; injection, powder, 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.