Is Douglas Pharmaceuticals America Limited FDA approved?

Douglas Pharmaceuticals America Limited holds 1 FDA-registered establishment in New Zealand. 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 Douglas Pharmaceuticals America Limited's drugs manufactured?

The FDA register lists Lincoln Auckland. Registered operations: analytical testing, labelling, finished drug manufacture, packaging, relabelling, repackaging.

What drugs does Douglas Pharmaceuticals America Limited make?

2 products are listed under Douglas Pharmaceuticals America Limited in the openFDA NDC Directory, most often as capsule. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Douglas Pharmaceuticals America Limited

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

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Registered sites: 1
Active NDC listings: 2
Live patents: 1
Countries: 1
Base: New Zealand

Authorisation

Registered operations

Analytical testing1Labelling1Finished drug manufacture1Packaging1Relabelling1Repackaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Douglas Manufacturing LimitedRegistrant: Douglas Pharmaceuticals America Limited	Corner Central Park Driveand Te Pai Place, Lincoln Auckland, 0610, New Zealand (NZL)	Analytical testing, Labelling, Finished drug manufacture, Packaging, Relabelling, Repackaging	3005641565590829388

Catalogue

Drug listings by form and route

2 active NDC listings: 2 drug for further processing. By marketing category: DRUG FOR FURTHER PROCESSING 2.

Dosage form	NDCs
capsule	2

Route	NDCs

Labeller name on the listing	NDCs
douglas manufacturing limited	2

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
8057811	VERSACLOZclozapine	product	May 2028

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Norethindrone Acetate And Ethinyl Estradiol Capsules And Ferrous Fumarate Capsules, 1 MG/20 MCG	capsule	58243-476DRUG FOR FURTHER PROCESSING
-	Norethindrone Acetate And Ethinyl Estradiol Capsules And Ferrous Fumarate Capsules, 1 MG/20 MCG	capsule	58243-477DRUG FOR FURTHER PROCESSING

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Comparable companies in New Zealand

Miers Laboratories Limited1 site · 9 NDC

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Common questions

Is Douglas Pharmaceuticals America Limited FDA approved?: Douglas Pharmaceuticals America Limited holds 1 FDA-registered establishment in New Zealand. 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 Douglas Pharmaceuticals America Limited's drugs manufactured?: The FDA register lists Lincoln Auckland. Registered operations: analytical testing, labelling, finished drug manufacture, packaging, relabelling, repackaging.
What drugs does Douglas Pharmaceuticals America Limited make?: 2 products are listed under Douglas Pharmaceuticals America Limited in the openFDA NDC Directory, most often as capsule. 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.