FEI 3001672072 of Olpha As | GDUFA | Fees | Self Identification | PharmaCompass.com

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Olpha

Olpha

VISIT THE VIRTUAL BOOTH, Contact Details

DIGITAL CONTENT

9 Corporate Content #SupplierSpotlight, 93 News #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

9 All APIs, 3 USDMF, 2 CEP/COS, 2 JDMF, 1 KDMF, 4 NDC API, 8 Listed APIs

INTERMEDIATES

20 ALL Intermediates

20 ALL Intermediates

FINISHED DOSAGE FORMULATIONS

33 FDF Dossiers, 33 Listed Dossiers

KEY PRODUCTS

1,3-Dimethyladamantane, 3-Quinuclidinone Hydrochloride, Chlorobutanol Hemihydrate, Memantine Hydrochloride, Rimantadine Hydrochloride

SERVICES

Clinical Trials, API Manufacturing, Drug Product Manufacturing, API & Drug Product Development

Clinical Trials
- 1 Clinical Development / Phase IIb-IV
API Manufacturing
- 1 Fine Chemical / Intermediate
Drug Product Manufacturing
- 1 Tablet
- 1 Capsule
API & Drug Product Development
- 2 API Development
- 2 Formulation Development

INSPECTIONS & REGISTRATIONS

3 FDA, 5 EDQM, 1 GDUFA

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GDUFA fees paid

USA

CPhI WW Frankfurt

Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.

Paid in : 2025

API Manufacturer : API MANUFACTURE

FDF Manufacturer :

Facility Name : Olpha AS

Business Address : 5 Rupnicu iela Olaine Olaine...

FEI Number : 3001672072

Country : Latvia

Paid in : 2025

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