Is Fine Chemicals Corporation (PTY) Ltd. FDA approved?

Fine Chemicals Corporation (PTY) Ltd. holds 1 FDA-registered establishment in South Africa. 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 Fine Chemicals Corporation (PTY) Ltd.'s drugs manufactured?

The FDA register lists Cape Town. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture, packaging, sterilize.

What drugs does Fine Chemicals Corporation (PTY) Ltd. make?

16 products are listed under Fine Chemicals Corporation (PTY) Ltd. in the openFDA NDC Directory, most often as powder. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Fine Chemicals Corporation (PTY) Ltd.

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

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Registered sites: 1
Active NDC listings: 16
Live patents: 0
Countries: 1
Base: South Africa

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1Finished drug manufacture1Packaging1sterilize1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Fine Chemicals Corporation (PTY) Ltd.	15 Hawkins Avenue, Epping 1, Cape Town, 7460, South Africa (ZAF)	Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture, Packaging, sterilize	3002806969568855923

Catalogue

Drug listings by form and route

16 active NDC listings: 16 bulk ingredient. By marketing category: BULK INGREDIENT 16.

Dosage form	NDCs
powder	16

Route	NDCs

Labeller name on the listing	NDCs
fine chemicals corporation (pty) ltd.	16

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	ARBACLOFEN	powder	48954-641BULK INGREDIENT
-	Azathioprine	powder	48954-909BULK INGREDIENT
-	Baclofen	powder	48954-469BULK INGREDIENT
-	Benztropine Mesylate	powder	48954-448BULK INGREDIENT
-	Cidofovir	powder	48954-728BULK INGREDIENT
-	Fluphenazine Decanoate	powder	48954-458BULK INGREDIENT
-	Fluphenazine Hydrochloride	powder	48954-468BULK INGREDIENT
-	Levalbuterol Hydrochloride	powder	48954-719BULK INGREDIENT
-	Methazolamide	powder	48954-472BULK INGREDIENT
-	Penbutolol Sulfate	powder	48954-699BULK INGREDIENT
-	Remifentanil Hydrochloride	powder	48954-724BULK INGREDIENT
-	Ropivacaine Hydrochloride	powder	48954-722BULK INGREDIENT
-	Scopolamine	powder	48954-540BULK INGREDIENT
-	Thiothixene	powder	48954-575BULK INGREDIENT
-	Vinblastine Sulfate	powder	48954-588BULK INGREDIENT
-	Vincristine Sulfate	powder	48954-587BULK INGREDIENT

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Enquiry

Common questions

Is Fine Chemicals Corporation (PTY) Ltd. FDA approved?: Fine Chemicals Corporation (PTY) Ltd. holds 1 FDA-registered establishment in South Africa. 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 Fine Chemicals Corporation (PTY) Ltd.'s drugs manufactured?: The FDA register lists Cape Town. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture, packaging, sterilize.
What drugs does Fine Chemicals Corporation (PTY) Ltd. make?: 16 products are listed under Fine Chemicals Corporation (PTY) Ltd. in the openFDA NDC Directory, most often as powder. 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.