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List of Certificates of Suitability (CEPs) for Dorzolamide Hydrochloride Active Pharmaceutical Ingredient (API) issued by the EDQM. Original Data: EDQM Database

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Product

Dorzolamide Hydrochloride
CEP/COS

Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.

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As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.

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Gensenta is a trusted CDMO partner with robust history, commitment to quality, innovative mindset and commitment to sustainability.

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Dorzolamide Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

37 API Suppliers, 14 USDMF, 13 CEP/COS, 4 JDMF, 8 EU WC, 12 KDMF, 14 NDC API, 27 Listed Suppliers, $ API Reference Price

37 API Suppliers
14 USDMF
13 CEP/COS
4 JDMF
8 EU WC
12 KDMF
14 NDC API
27 Listed Suppliers
$ API Reference Price

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Imports

API Reference Price
API Exports
API Imports
FDF Imports

INTERMEDIATES

9 API Suppliers

9 API Suppliers

FINISHED DOSAGE FORMULATIONS

173 FDF Dossiers, 35 FDA Orange Book, 96 Europe, 17 Canada, 4 Australia, 7 South Africa, 14 Listed Dossiers

173 FDF Dossiers
35 FDA Orange Book
96 Europe
17 Canada
4 Australia
7 South Africa
14 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION/DROPS;OPHTHALMIC - EQ 2% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION/DROPS;OPHTHALMIC - EQ 2% BASE;EQ 0.5% BASE

SOLUTION/DROPS;OPHTHALMIC - EQ 2% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION/DROPS;OPHTHALMIC - EQ 2% BASE;EQ 0.5% BASE

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 12 SPI Pharma, 3 DKSH, 1 Pfanstiehl, 4 Actylis, 1 BASF, 1 Finar, 2 Gangwal Chemicals, 1 Ingredion Pharma Solutions, 2 Kerry, 2 Microlex e.U, 1 Pluviaendo, 3 Roquette, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 1 Sigachi Industries

1 Rochem International Inc
12 SPI Pharma
3 DKSH
1 Pfanstiehl
4 Actylis
1 BASF
1 Finar
2 Gangwal Chemicals
1 Ingredion Pharma Solutions
2 Kerry
2 Microlex e.U
1 Pluviaendo
3 Roquette
1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shijiazhuang Huaxu Pharmaceutical
1 Sigachi Industries

EXCIPIENTS BY APPLICATIONS

17 Fillers, Diluents & Binders, 10 Chewable & Orodispersible Aids, 9 Taste Masking, 9 Direct Compression, 5 Parenteral, 4 Thickeners and Stabilizers, 3 Disintegrants & Superdisintegrants, 3 Granulation, 3 Topical, 3 Rheology Modifiers, 3 Co-Processed Excipients, 2 Solubilizers, 2 Controlled & Modified Release, 1 API Stability Enhancers

17 Fillers, Diluents & Binders
10 Chewable & Orodispersible Aids
9 Taste Masking
9 Direct Compression
5 Parenteral
4 Thickeners and Stabilizers
3 Disintegrants & Superdisintegrants
3 Granulation
3 Topical
3 Rheology Modifiers
3 Co-Processed Excipients
2 Solubilizers
2 Controlled & Modified Release
1 API Stability Enhancers

DIGITAL CONTENT

16 NEWS #PharmaBuzz

16 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

4 US Medicaid Prescriptions, 76 Finished Drug Prices

4 US Medicaid Prescriptions
76 Finished Drug Prices

MARKET PLACE

14 APIs, 1 FDF Dossiers

14 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

2 Health Canada Patents

2 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 4 USP, 4 JP, 6 Others

3 EDQM
4 USP
4 JP
6 Others

$ API Ref.Price (USD/KG) : 3,161 Xls

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filter Certificate Holder Reset all filters

14 All

01 1PCAS Ecully FR

02 2NEULAND LABORATORIES LIMITED Hyderabad IN

03 1BACHEM S.A. Vionnaz CH

04 1CURIA SPAIN S.A.U. Boecillo ES

05 1F.I.S. - FABBRICA ITALIANA SINTETICI S.P.A. Montecchio Maggiore IT

06 2FDC Limited Mumbai IN

07 1HETERO DRUGS LIMITED Hyderabad IN

08 2INDOCO REMEDIES LIMITED Mumbai IN

09 2MICRO LABS LIMITED Bengaluru IN

10 1TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL

filter Substance Reset all filters

14 All

01 10Dorzolamide hydrochloride

02 1Dorzolamide hydrochloride, Process 2

03 2Dorzolamide hydrochloride, Process II

04 1Dorzolamide hydrochloride, Process-II

filter Country Reset all filters

14 All

01 1France

02 9India

03 1Israel

04 1Italy

05 1Switzerland

06 1U.S.A

filter Status Reset all filters

14 All

01 13Valid

02 1Withdrawn by Holder

API Suppliers
USDMF
CEP/COS
JDMF
EU WC
KDMF
NDC API
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Product Main Page

PCAS Ecully FR

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Digital Content

Dorzolamide hydrochloride

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

Certificate Number

R1-CEP 2012-023 - Rev 01

Status

Valid

Type

Chemical

Issue Date

2020-07-30

End Date

Substance Number

2359

Seqens Company Banner

01

PCAS Ecully FR

BioJapan 2024

Not Confirmed

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Digital Content

Dorzolamide hydrochloride

Certificate Number : R1-CEP 2012-023 - Rev 01

Status : Valid

Issue Date : 2020-07-30

Type : Chemical

Substance Number : 2359

Seqens Company Banner

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

NEULAND LABORATORIES LIMITED Hydera...

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Neuland Laboratories- A dedicated 100% API provider.

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Digital Content

Dorzolamide hydrochloride, Process II

Product Web Link

Digital Content

Certificate Number

R1-CEP 2017-089 - Rev 00

Status

Valid

Type

Chemical

Issue Date

2022-08-22

End Date

Substance Number

2359

02

NEULAND LABORATORIES LIMITED Hydera...

TIDES Europe 2024

Neuland Laboratories- A dedicated 100% API provider.

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Digital Content

Dorzolamide hydrochloride, Process II

Certificate Number : R1-CEP 2017-089 - Rev 00

Status : Valid

Issue Date : 2022-08-22

Type : Chemical

Substance Number : 2359

Product Web Link

Digital Content

NEULAND LABORATORIES LIMITED Hydera...

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Neuland Laboratories- A dedicated 100% API provider.

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Contact Supplier

Digital Content