Is PharmaEssentia Corporation FDA approved?

PharmaEssentia Corporation holds 1 FDA-registered establishment in Taiwan. 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 PharmaEssentia Corporation's drugs manufactured?

The FDA register lists Taichung. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.

What drugs does PharmaEssentia Corporation make?

2 products are listed under PharmaEssentia Corporation in the openFDA NDC Directory, most often as injection; injection, solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

PharmaEssentia Corporation

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: Taiwan

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1Finished drug manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
PharmaEssentia Corporation, Taichung PlantRegistrant: PharmaEssentia Corporation	3F, No. 28, Keya West Rd., Daya Dist,, Taichung, 428, Taiwan (TWN)	Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture	2000012832658873411

Catalogue

Drug listings by form and route

2 active NDC listings: 2 human prescription drug. By marketing category: BLA 2.

Dosage form	NDCs
injection	1
injection, solution	1

Route	NDCs
subcutaneous	2

Labeller name on the listing	NDCs
pharmaessentia usa	2

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
BESREMi	ROPEGINTERFERON ALFA-2B	injection, subcutaneous	73536-500BLA
BESREMi Pen	ROPEGINTERFERON ALFA-2B	injection, solution, subcutaneous	73536-511BLA

Neighbours

Registered in the same town

YUNG ZIP CHEMICAL IND. CO., LTD.Taichung, TWN

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Seven Star Pharmaceutical Co., Ltd.1 site · 4 NDC

Enquiry

Common questions

Is PharmaEssentia Corporation FDA approved?: PharmaEssentia Corporation holds 1 FDA-registered establishment in Taiwan. 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 PharmaEssentia Corporation's drugs manufactured?: The FDA register lists Taichung. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.
What drugs does PharmaEssentia Corporation make?: 2 products are listed under PharmaEssentia Corporation in the openFDA NDC Directory, most often as injection; injection, 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.