Is PURAC BIOQUIMICA SA FDA approved?

PURAC BIOQUIMICA SA holds 1 FDA-registered establishment in Spain. 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 PURAC BIOQUIMICA SA's drugs manufactured?

The FDA register lists Montmelo. Registered operations: active ingredient (API) manufacture.

What drugs does PURAC BIOQUIMICA SA make?

2 products are listed under PURAC BIOQUIMICA SA in the openFDA NDC Directory, most often as liquid. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

PURAC BIOQUIMICA SA

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

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Registered sites: 1
Active NDC listings: 2
Live patents: 0
Countries: 1
Base: Spain

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
PURAC BIOQUIMICA SA	CALLE GRAN VIAL, 19 -25, Montmelo, Barcelona E-08160, Spain (ESP)	Active ingredient (API) manufacture	3003789425460041270

Catalogue

Drug listings by form and route

2 active NDC listings: 2 bulk ingredient. By marketing category: BULK INGREDIENT 2.

Dosage form	NDCs
liquid	2

Route	NDCs

Labeller name on the listing	NDCs
purac bioquimica, s.a.	2

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	LACTIC ACID, DL-	liquid	68867-000BULK INGREDIENT
-	SODIUM LACTATE, L-	liquid	68867-001BULK INGREDIENT

Neighbours

Registered in the same town

Farmhispania S.A.Montmelo, ESP

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Enquiry

Common questions

Is PURAC BIOQUIMICA SA FDA approved?: PURAC BIOQUIMICA SA holds 1 FDA-registered establishment in Spain. 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 PURAC BIOQUIMICA SA's drugs manufactured?: The FDA register lists Montmelo. Registered operations: active ingredient (API) manufacture.
What drugs does PURAC BIOQUIMICA SA make?: 2 products are listed under PURAC BIOQUIMICA SA in the openFDA NDC Directory, most often as liquid. 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.