Olpha DMF, CEP, Written Confirmations, FDF, Prices, Patents, Patents & Exclusivities, Dossier, Manufacturer, Licensing, Distributer, Suppliers, News

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

02

Memantine Hydrochloride

Latvia

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Duphat

Not Confirmed

USDMF

CEP/COS JDMF

EU-WC NDC

KDMF

VMF ASMF

AUDIT

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

03

Anagrelide Hydrochloride

Latvia

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Duphat

Not Confirmed

USDMF

CEP/COS JDMF EU-WC NDC

KDMF VMF Others AUDIT

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

04

Chlorobutanol Hemihydrate

Latvia

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Duphat

Not Confirmed

USDMF CEP/COS

JDMF EU-WC NDC

KDMF VMF ASMF

AUDIT

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

05

Memantine Hydrochloride

Latvia

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Duphat

Not Confirmed

USDMF CEP/COS JDMF

EU-WC NDC

KDMF

VMF ASMF

AUDIT

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

06

Rimantadine Hydrochloride

Latvia

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Duphat

Not Confirmed

USDMF

CEP/COS JDMF EU-WC NDC

KDMF VMF ASMF

AUDIT

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

07

Furazidin

Latvia

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Duphat

Not Confirmed

USDMF CEP/COS JDMF EU-WC NDC KDMF VMF ASMF

AUDIT

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

08

Meldonium

Latvia

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Duphat

Not Confirmed

USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

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

09

Nitrofurantoin

Latvia

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Duphat

Not Confirmed

USDMF CEP/COS JDMF EU-WC NDC KDMF VMF ASMF

AUDIT

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

10

Phenazepam

Latvia

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Duphat

Not Confirmed

USDMF CEP/COS JDMF EU-WC NDC KDMF VMF ASMF

AUDIT

Only 10 entries up to this point, click to access all

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USDMF

01

Amantadine Hydrochloride

Latvia

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

Olpha

GDUFA

DMF Review : Complete

Rev. Date : 2013-11-20

Pay. Date : 2012-11-27

DMF Number : 23528

Submission : 2010-02-11

Status : Active

Type : II

02

Anagrelide Hydrochloride

Latvia

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

Olpha

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 17041

Submission : 2003-12-16

Status : Active

Type : II

03

Memantine Hydrochloride

Latvia

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

Olpha

GDUFA

DMF Review : Complete

Rev. Date : 2013-02-07

Pay. Date : 2012-11-27

DMF Number : 20543

Submission : 2007-05-09

Status : Active

Type : II

04

Rimantadine Hydrochloride

Latvia

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

Olpha

GDUFA

DMF Review : Complete

Rev. Date : 2014-06-17

Pay. Date : 2012-11-27

DMF Number : 15210

Submission : 2000-12-21

Status : Active

Type : II

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CEP/COS

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JDMF

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KDMF

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NDC API

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LISTED APIs

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Drugs in Development

01 Olpha

Latvia

Duphat

Not Confirmed

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

Lead Product(s) : Furazidin

Therapeutic Area : Infections and Infectious Diseases

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Undisclosed

Deal Type : Agreement

JSC Olainfarm & Adalvo to Launch a New Urology Product in 17 Countries In 2022-2023

Details : In partnership Olainfarm will manage Furagins (Furaginum) regulatory affairs, distribution and promotion in Latvia, Russia, Kazakhstan, Belarus, Ukraine, and other countries and Adalvo will be responsible for development, manufacturing and will support m...

Brand Name : Furagins

Molecule Type : Small molecule

Upfront Cash : Undisclosed

June 16, 2021

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02 Silvanols

Latvia

Duphat

Not Confirmed

Lead Product(s) : Tabebuia Avellandae,Olea Europea,Zinc Glycinate

Therapeutic Area : Infections and Infectious Diseases

Highest Development Status : Approved

Partner/Sponsor/Collaborator : University of Latvia

Deal Size : Not Applicable

Deal Type : Not Applicable

Latvia Can! A New Remedy for Respiratory Diseases Created and Researched!

Details : Goimmune Strong contains bark extract of pink tabebuia, olive leaf extract, brazilian green propolis, zinc bisglycinate and organic selenium. It promotes the protection of cells against oxidative stress and showed antibacterial activity in respiratory di...

Brand Name : Goimmune Strong

Molecule Type : Small molecule

Upfront Cash : Not Applicable

February 02, 2021

03 Silvanols

Latvia

Duphat

Not Confirmed

Lead Product(s) : Lactium,Ginseng Extract,Crocus Sativus

Therapeutic Area : Neurology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : University of Lorraine

Deal Size : Not Applicable

Deal Type : Not Applicable

Silvanols Launches the First Combined Product in Latvia with The Innovative Ingredient Lactium® �...

Details : GoRelax (lactium), specially patented cow’s milk protein split, has shown that this rotein improves sleep and is a natural anti-anxiety agent that helps reduce signs of stress.

Brand Name : GoRelax Day

Molecule Type : Small molecule

Upfront Cash : Not Applicable

March 26, 2020

04 Silvanols

Latvia

Duphat

Not Confirmed

Lead Product(s) : Tabebuia Avellandae Extract,Olea Europea Extract,Zinc Glycinate

Therapeutic Area : Infections and Infectious Diseases

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Silvanols Puts Special Emphasis on A Research-Based and Developed Agent to Strengthen the Body’s...

Details : GoImmune STRONG (tabebuia avellandae extract), a unique remedy for the season of the common cold, which includes green propolis, tabebuia bark and olive leaf extracts, as well as zinc and selenium.

Brand Name : GoImmune STRONG

Molecule Type : Small molecule

Upfront Cash : Not Applicable

February 28, 2020

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FDF Dossiers

01

Brand Name : Herpelān

Latvia

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

Regulatory Info :

Registration Country : Latvia

Aciclovir

Olpha

Dosage Form : Tablet

Dosage Strength : 200MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Latvia

02

Brand Name : Neomidantan

Latvia

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

Regulatory Info :

Registration Country : Latvia

Amantadine Hydrochloride

Olpha

Dosage Form : Capsule

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Latvia

03

Brand Name : Ambroksol

Latvia

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

Regulatory Info :

Registration Country : Latvia

Ambroxol Hydrochloride

Olpha

Dosage Form : Tablet

Dosage Strength : 30MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Latvia

04

Brand Name : Eifilin

Latvia

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

Regulatory Info :

Registration Country : Latvia

Aminophylline

Olpha

Dosage Form : Tablet

Dosage Strength : 150MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Latvia

05

Brand Name : N/A

Latvia

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

Regulatory Info : Dossier Readiness: Q1 2026

Registration Country : Latvia

Cabozantinib

Olpha

Dosage Form : Tablet

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info : Dossier Readiness: Q1 2026

Registration Country : Latvia

06

Brand Name : Ciprofloxacin Olainf...

Latvia

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

Regulatory Info :

Registration Country : Latvia

Ciprofloxacin

Olpha

Dosage Form : Film-Coated Tablet

Dosage Strength : 500MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Latvia

07

Brand Name : N/A

Latvia

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

Regulatory Info : Dossier Readiness: DCP submitted

Registration Country : Latvia

Dapagliflozin

Olpha

Dosage Form : Tablet

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info : Dossier Readiness: DCP submitted

Registration Country : Latvia

08

Brand Name : N/A

Latvia

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

Regulatory Info : Dossier Readiness: Q2 2025

Registration Country : Latvia

Dapagliflozin; Metformin

Olpha

Dosage Form : Tablet

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info : Dossier Readiness: Q2 2025

Registration Country : Latvia

09

Brand Name : Dutasteride/Tamsulos...

Latvia

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

Regulatory Info :

Registration Country : Latvia

Dutasteride; Tamsulosin Hydrochloride

Olpha

Dosage Form : Hard Capsule

Dosage Strength : 0.5MG; 0.4MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Latvia

10

Brand Name : N/A

Latvia

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

Regulatory Info : Dossier Readiness: Q1 2025

Registration Country : Latvia

Empagliflozin

Olpha

Dosage Form : Tablet

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info : Dossier Readiness: Q1 2025

Registration Country : Latvia

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Listed Dossiers

01

Brand Name : Herpelān

Latvia

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

Regulatory Info :

Registration Country : Latvia

Aciclovir

Olpha

Dosage Form : Tablet

Dosage Strength : 200MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Latvia

02

Brand Name : Neomidantan

Latvia

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

Regulatory Info :

Registration Country : Latvia

Amantadine Hydrochloride

Olpha

Dosage Form : Capsule

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Latvia

03

Brand Name : Ambroksol

Latvia

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

Regulatory Info :

Registration Country : Latvia

Ambroxol Hydrochloride

Olpha

Dosage Form : Tablet

Dosage Strength : 30MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Latvia

04

Brand Name : Eifilin

Latvia

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

Regulatory Info :

Registration Country : Latvia

Aminophylline

Olpha

Dosage Form : Tablet

Dosage Strength : 150MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Latvia

05

Brand Name : N/A

Latvia

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

Regulatory Info : Dossier Readiness: Q1 2026

Registration Country : Latvia

Cabozantinib

Olpha

Dosage Form : Tablet

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info : Dossier Readiness: Q1 2026

Registration Country : Latvia

06

Brand Name : Ciprofloxacin Olainf...

Latvia

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

Regulatory Info :

Registration Country : Latvia

Ciprofloxacin

Olpha

Dosage Form : Film-Coated Tablet

Dosage Strength : 500MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Latvia

07

Brand Name : N/A

Latvia

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

Regulatory Info : Dossier Readiness: DCP submitt...

Registration Country : Latvia

Dapagliflozin

Olpha

Dosage Form : Tablet

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info : Dossier Readiness: DCP submitt...

Registration Country : Latvia

08

Brand Name : N/A

Latvia

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

Regulatory Info : Dossier Readiness: Q2 2025

Registration Country : Latvia

Dapagliflozin; Metformin

Olpha

Dosage Form : Tablet

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info : Dossier Readiness: Q2 2025

Registration Country : Latvia

09

Brand Name : Dutasteride/Tamsulos...

Latvia

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

Regulatory Info :

Registration Country : Latvia

Dutasteride; Tamsulosin Hydrochloride

Olpha

Dosage Form : Hard Capsule

Dosage Strength : 0.5MG; 0.4MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Latvia

10

Brand Name : N/A

Latvia

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

Regulatory Info : Dossier Readiness: Q1 2025

Registration Country : Latvia

Empagliflozin

Olpha

Dosage Form : Tablet

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info : Dossier Readiness: Q1 2025

Registration Country : Latvia

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ALL Intermediates

01

1-Adamantyl methyl ketone (1-Acetyladamantane)

Latvia

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

Olpha

CAS Number : 1660-04-4

End Use API : Rimantadine Hydrochloride

02

1,3-Dimethyladamantane

Latvia

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

Olpha

CAS Number : 702-79-4

End Use API : Memantine Hydrochloride

03

3-Amino-1-hydroxy-adamantane

Latvia

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

Olpha

CAS Number : 702-82-9

End Use API : Vildagliptin

04

1-Chloro-3,5-dimethyladamantane

Latvia

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

Olpha

CAS Number : 707-36-8

End Use API : Memantine Hydrochloride

05

1-Hydroxy-3,5-dimethyladamantane

Latvia

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

Olpha

CAS Number : 707-37-9

End Use API : Memantine Hydrochloride

06

Adamantanemethanol

Latvia

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

Olpha

CAS Number : 770-71-8

End Use API : Rimantadine Hydrochloride

07

1-Acetylamido-3,5-dimethyladamantane

Latvia

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

Olpha

CAS Number : 19982-07-1

End Use API : Memantine Hydrochloride

08

3-Quinuclidinone hydrochloride

Latvia

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

Olpha

CAS Number : 1193-65-3

End Use API : Cevimeline Hydrochloride

09

3-Quinuclidinone hydrochloride

Latvia

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

Olpha

CAS Number : 1193-65-3

End Use API : Aclidinium Bromide

10

3-Quinuclidinol

Latvia

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

Olpha

CAS Number : 1619-34-7

End Use API : Aceclidine Hydrochloride