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Veranova A CDMO that manages complexity with confidence

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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Laboratorium Ofichem B.V

Laboratorium Ofichem B.V

LABORATORIUM OFICHEM B.V

About, Contact Details

EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

PRESENTATION(s)

Product List 2022, Corporate Presentation, GMP Certificate 2021, Product List 2021

VIDEO(s)

Corporate Video, World's Dependence on China's Medicinal Power, Ondernemen in Oost Groningen

DIGITAL CONTENT

29 News

29 News

APIs // Active Pharmaceutical Ingredients

40 APIs, 3 USDMF, 4 CEP/COS, 2 JDMF, 2 NDC API, 38 Listed APIs

DEVELOPMENTS

1 Drug(s) in Development

1 Drug(s) in Development

KEY PRODUCTS

Dimethyl Fumarate, Histamine Dihydrochloride, Histamine Diphosphate Monohydrate, Methenamine Mandelate, Pamidronate, Phenylacetyl Disulfide, Potassium Bromide, Zinc Acetate

Dimethyl Fumarate
Histamine Dihydrochloride
Histamine Diphosphate Monohydrate
Methenamine Mandelate
Pamidronate
Phenylacetyl Disulfide
Potassium Bromide
Zinc Acetate

SERVICES

All Services, API Manufacturing, API & Drug Product Development

All Services
API Manufacturing
- 1 GMP Manufacturing
- 1 Small Scale Batch
API & Drug Product Development
- 3 API Development

KEY SERVICES

API Development Services, Small Scale Batch for APIs, API Small Scale Batch Manufacturing

API Development Services
Small Scale Batch for APIs
API Small Scale Batch Manufacturing

INSPECTIONS & REGISTRATIONS

2 FDA, 1 EDQM, 1 GDUFA

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Laboratorium Ofichem B.V

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Laboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.

Histamine Dihydrochloride

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USDMF

Found USDMF

Application Number

34358

Status

Active

Filing Details

HISTAMINE DI-HYDROCHLORIDE

Issue/Submission Date

2020-03-17

CEP/COS

Found CEP/COS

Application Number

R0-CEP 2020-131 - Rev 00

Status

Valid

Filing Details

Histamine dihydrochloride

Issue/Submission Date

2023-01-25

Japanese DMF

JDMF

Application Number

Status

Filing Details

Issue/Submission Date

Written Confirmation

WC

Application Number

Status

Filing Details

Issue/Submission Date

Application Number

34358

R0-CEP 2020-131 - Rev 00

Status

Active
Fees Paid
N/A

Valid

Filing Details

HISTAMINE DI-HYDROCHLORIDE

Histamine dihydrochloride

Issue/Submission Date

2020-03-17

2023-01-25

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Booth # 81C70

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Laboratorium Ofichem B.V

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Laboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.

Pamidronate

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USDMF

USDMF

Application Number

Status

Filing Details

Issue/Submission Date

CEP/COS

Found CEP/COS

Application Number

R0-CEP 2017-203 - Rev 00

Status

Valid

Filing Details

Pamidronate disodium pentahydrate

Issue/Submission Date

2019-03-01

Japanese DMF

Found JDMF

Application Number

228MF10223

Status

Filing Details

PAMIDRONATE DISODIUM PENTAHYDRATE a...

Issue/Submission Date

2016-11-25

Written Confirmation

WC

Application Number

Status

Filing Details

Issue/Submission Date

Application Number

R0-CEP 2017-203 - Rev 00

228MF10223

Status

Valid

Filing Details

Pamidronate disodium pentahydrate

PAMIDRONATE DISODIUM PENTAHYDRATE a...

Issue/Submission Date

2019-03-01

2016-11-25

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Booth # 81C70

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Laboratorium Ofichem B.V

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Laboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.

Carboplatin

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USDMF

USDMF

Application Number

Status

Filing Details

Issue/Submission Date

CEP/COS

Found CEP/COS

Application Number

R1-CEP 2005-038 - Rev 00

Status

Valid

Filing Details

Carboplatin

Issue/Submission Date

2014-05-13

Japanese DMF

JDMF

Application Number

Status

Filing Details

Issue/Submission Date

Written Confirmation

WC

Application Number

Status

Filing Details

Issue/Submission Date

Application Number

R1-CEP 2005-038 - Rev 00

Status

Valid

Filing Details

Carboplatin

Issue/Submission Date

2014-05-13

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Booth # 81C70

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Laboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.

Cisplatin

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USDMF

USDMF

Application Number

Status

Filing Details

Issue/Submission Date

CEP/COS

Found CEP/COS

Application Number

R1-CEP 1999-127 - Rev 04

Status

Valid

Filing Details

Cisplatin

Issue/Submission Date

2013-08-01

Japanese DMF

JDMF

Application Number

Status

Filing Details

Issue/Submission Date

Written Confirmation

WC

Application Number

Status

Filing Details

Issue/Submission Date

Application Number

R1-CEP 1999-127 - Rev 04

Status

Valid

Filing Details

Cisplatin

Issue/Submission Date

2013-08-01

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Booth # 81C70

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Laboratorium Ofichem B.V

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Laboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.

Dimethyl Fumarate

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USDMF

Found USDMF

Application Number

31053

Status

Active

Filing Details

DIMETHYL FUMARATE

Issue/Submission Date

2017-01-12

CEP/COS

CEP/COS

Application Number

Status

Filing Details

Issue/Submission Date

Japanese DMF

JDMF

Application Number

Status

Filing Details

Issue/Submission Date

Written Confirmation

WC

Application Number

Status

Filing Details

Issue/Submission Date

Application Number

31053

Status

Active
Fees Paid
Reviewed

Filing Details

DIMETHYL FUMARATE

Issue/Submission Date

2017-01-12

Ofichem Company Banner

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Booth # 81C70

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Laboratorium Ofichem B.V

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Laboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.

Edetate Calcium Disodium

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USDMF

Found USDMF

Application Number

36993

Status

Active

Filing Details

EDETATE CALCIUM DISODIUM

Issue/Submission Date

2022-07-13

CEP/COS

CEP/COS

Application Number

Status

Filing Details

Issue/Submission Date

Japanese DMF

JDMF

Application Number

Status

Filing Details

Issue/Submission Date

Written Confirmation

WC

Application Number

Status

Filing Details

Issue/Submission Date

Application Number

36993

Status

Active
Fees Paid
Reviewed

Filing Details

EDETATE CALCIUM DISODIUM

Issue/Submission Date

2022-07-13

Ofichem Company Banner

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Booth # 81C70

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Laboratorium Ofichem B.V

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Laboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.

Zinc Acetate

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USDMF

USDMF

Application Number

Status

Filing Details

Issue/Submission Date

CEP/COS

CEP/COS

Application Number

Status

Filing Details

Issue/Submission Date

Japanese DMF

Found JDMF

Application Number

304MF10017

Status

Filing Details

Zinc Acetate Dihydrate at Heembadwe...

Issue/Submission Date

2022-01-20

Written Confirmation

WC

Application Number

Status

Filing Details

Issue/Submission Date

Application Number

304MF10017

Status

Filing Details

Zinc Acetate Dihydrate at Heembadwe...

Issue/Submission Date

2022-01-20

Ofichem Company Banner

CPhI Worldwide 2023

Booth # 81C70

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Laboratorium Ofichem B.V

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Laboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.

2-Deoxy-D-Glucose

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USDMF

USDMF

Application Number

Status

Filing Details

Issue/Submission Date

CEP/COS

CEP/COS

Application Number

Status

Filing Details

Issue/Submission Date

Japanese DMF

JDMF

Application Number

Status

Filing Details

Issue/Submission Date

Written Confirmation

WC

Application Number

Status

Filing Details

Issue/Submission Date

Application Number

Status

Filing Details

Issue/Submission Date

Ofichem Company Banner

CPhI Worldwide 2023

Booth # 81C70

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Laboratorium Ofichem B.V

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Laboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.

3-Hydroxybutanoate

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USDMF

USDMF

Application Number

Status

Filing Details

Issue/Submission Date

CEP/COS

CEP/COS

Application Number

Status

Filing Details

Issue/Submission Date

Japanese DMF

JDMF

Application Number

Status

Filing Details

Issue/Submission Date

Written Confirmation

WC

Application Number

Status

Filing Details

Issue/Submission Date

Application Number

Status

Filing Details

Issue/Submission Date

Ofichem Company Banner

CPhI Worldwide 2023

Booth # 81C70

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Laboratorium Ofichem B.V

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Laboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.

Bupropion Hydrochloride

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USDMF

USDMF

Application Number

Status

Filing Details

Issue/Submission Date

CEP/COS

CEP/COS

Application Number

Status

Filing Details

Issue/Submission Date

Japanese DMF

JDMF

Application Number

Status

Filing Details

Issue/Submission Date

Written Confirmation

WC

Application Number

Status

Filing Details

Issue/Submission Date

Application Number

Status

Filing Details

Issue/Submission Date

Ofichem Company Banner

CPhI Worldwide 2023

Booth # 81C70

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Laboratorium Ofichem B.V

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Laboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.

Calcium Monoethyl Fumarate

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USDMF

USDMF

Application Number

Status

Filing Details

Issue/Submission Date

CEP/COS

CEP/COS

Application Number

Status

Filing Details

Issue/Submission Date

Japanese DMF

JDMF

Application Number

Status

Filing Details

Issue/Submission Date

Written Confirmation

WC

Application Number

Status

Filing Details

Issue/Submission Date

Application Number

Status

Filing Details

Issue/Submission Date

Ofichem Company Banner

CPhI Worldwide 2023

Booth # 81C70

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Laboratorium Ofichem B.V

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Laboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.

Cannabidiol

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USDMF

USDMF

Application Number

Status

Filing Details

Issue/Submission Date

CEP/COS

CEP/COS

Application Number

Status

Filing Details

Issue/Submission Date

Japanese DMF

JDMF

Application Number

Status

Filing Details

Issue/Submission Date

Written Confirmation

WC

Application Number

Status

Filing Details

Issue/Submission Date

Application Number

Status