Athena Athena

X

List of Certificates of Suitability (CEPs) for Gemcitabine Hydrochloride Active Pharmaceutical Ingredient issued by the EDQM and listed on PharmaCompass.com

PharmaCompass
API SUPPLIERS
API Suppliers

API Suppliers

US DMFs Filed

US DMFs Filed

CEP/COS Certifications

CEP/COS Certifications

JDMFs Filed

JDMFs Filed

Other Certificates

Other Certificates

Other Suppliers

Other Suppliers

API REF. PRICE (USD / KG)
INTERMEDIATES
DOSSIERS // FDF
USA (Orange Book)

USA (Orange Book)

Europe

Europe

Canada

Canada

Australia

Australia

South Africa

South Africa

Uploaded Dossiers

Uploaded Dossiers

GLOBAL SALES (USD Million)

U.S. Medicaid

Annual Reports

EXCIPIENTS
PATENTS & EXCLUSIVITIES

USFDA Orange Book Patents

USFDA Exclusivities

0

DIGITAL CONTENT

Blog #PharmaFlow

News

REF STANDARD

EDQM

USP

JP

0

Other Listed Suppliers

SERVICES

0

Flag India
Digital Content Digital Content
URL Supplier Web Content
R0-CEP 2011-025 - Rev 01
Withdrawn by EDQM F...
Chemical
2014-04-25
2020-03-13
2306
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
Flag India
Digital Content Digital Content
URL Supplier Web Content
R0-CEP 2011-023 - Rev 01
Withdrawn by EDQM F...
Chemical
2014-04-25
2020-03-13
2306
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
Flag India
Digital Content Digital Content
URL Supplier Web Content
R1-CEP 2013-226 - Rev 00
Withdrawn by Holder
Chemical
2020-05-12
2021-08-12
2306
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
Flag U.S.A
Digital Content Digital Content
URL Supplier Web Content
R1-CEP 2007-063 - Rev 00
Valid
Chemical
2014-11-07
2306
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
Flag Spain
Digital Content Digital Content
URL Supplier Web Content
R1-CEP 2011-032 - Rev 01
Valid
Chemical
2017-09-27
2306
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
Flag India
Digital Content Digital Content
URL Supplier Web Content
R1-CEP 2012-080 - Rev 01
Valid
Chemical
2019-10-08
2306
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
Flag India
Digital Content Digital Content
URL Supplier Web Content
CEP 2023-271 - Rev 00
Valid
Chemical
2023-12-06
2306
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
Flag India
Digital Content Digital Content
URL Supplier Web Content
R1-CEP 2008-131 - Rev 04
Valid
Chemical
2022-02-11
2306
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
Flag China
Digital Content Digital Content
URL Supplier Web Content
R1-CEP 2009-042 - Rev 01
Valid
Chemical
2015-10-16
2306
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
Flag China
Digital Content Digital Content
URL Supplier Web Content
R1-CEP 2017-076 - Rev 00
Valid
Chemical
2023-02-28
2306
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
Flag India
Digital Content Digital Content
URL Supplier Web Content
R0-CEP 2022-499 - Rev 00
Valid
Chemical
2023-02-28
2306
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
Flag India
Digital Content Digital Content
URL Supplier Web Content
R1-CEP 2009-208 - Rev 02
Valid
Chemical
2020-11-02
2306
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
Flag India
Digital Content Digital Content
URL Supplier Web Content
R1-CEP 2009-089 - Rev 02
Valid
Chemical
2022-07-13
2306
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
Flag India
Digital Content Digital Content
URL Supplier Web Content
R0-CEP 2022-092 - Rev 00
Valid
Chemical
2022-07-13
2306
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
Flag India
Digital Content Digital Content
URL Supplier Web Content
R1-CEP 2009-026 - Rev 02
Valid
Chemical
2023-01-24
2306
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
Flag India
Digital Content Digital Content
URL Supplier Web Content
R0-CEP 2015-054 - Rev 00
Expired
Chemical
2015-07-31
2020-07-31
2306
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
Flag Taiwan
Digital Content Digital Content
URL Supplier Web Content
R1-CEP 2006-272 - Rev 06
Valid
Chemical
2022-09-08
2306
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
Flag India
Digital Content Digital Content
URL Supplier Web Content
CEP 2017-187 - Rev 02
Valid
Chemical
2024-01-04
2306
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
Flag India
Digital Content Digital Content
URL Supplier Web Content
R1-CEP 2006-222 - Rev 01
Valid
Chemical
2023-02-23
2306
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
Flag India
Digital Content Digital Content
URL Supplier Web Content
R1-CEP 2007-021 - Rev 01
Valid
Chemical
2015-07-28
2306
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
Flag Israel
Digital Content Digital Content
URL Supplier Web Content
R1-CEP 2013-218 - Rev 02
Valid
Chemical
2021-12-20
2306
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
Flag Israel
Digital Content Digital Content
URL Supplier Web Content
R1-CEP 2008-161 - Rev 02
Valid
Chemical
2021-12-20
2306
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
Flag China
Digital Content Digital Content
URL Supplier Web Content
R0-CEP 2011-117 - Rev 01
Withdrawn by Holder
Chemical
2015-02-05
2020-10-15
2306
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
left grey arrow
right gray arrow
  • INJECTABLE;INJECTION - EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • INJECTABLE;INJECTION - EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SOLUTION;INTRAVENOUS - EQ 1200MG BASE/120ML (EQ 10MG BASE/ML)
  • SOLUTION;INTRAVENOUS - EQ 1300MG BASE/130ML (EQ 10MG BASE/ML)
  • SOLUTION;INTRAVENOUS - EQ 1400MG BASE/140ML (EQ 10MG BASE/ML)
  • SOLUTION;INTRAVENOUS - EQ 1500MG BASE/150ML (EQ 10MG BASE/ML)
  • SOLUTION;INTRAVENOUS - EQ 1600MG BASE/160ML (EQ 10MG BASE/ML)
  • SOLUTION;INTRAVENOUS - EQ 1700MG BASE/170ML (EQ 10MG BASE/ML)
  • SOLUTION;INTRAVENOUS - EQ 1800MG BASE/180ML (EQ 10MG BASE/ML)
  • SOLUTION;INTRAVENOUS - EQ 1900MG BASE/190ML (EQ 10MG BASE/ML)
  • SOLUTION;INTRAVENOUS - EQ 2000MG BASE/200ML (EQ 10MG BASE/ML)
  • SOLUTION;INTRAVENOUS - EQ 2200MG BASE/220ML (EQ 10MG BASE/ML)

Looking for 122111-03-9 / Gemcitabine API manufacturers, exporters & distributors?

Gemcitabine manufacturers, exporters & distributors 1

91

PharmaCompass offers a list of Gemcitabine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Gemcitabine manufacturer or Gemcitabine supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Gemcitabine manufacturer or Gemcitabine supplier.

PharmaCompass also assists you with knowing the Gemcitabine API Price utilized in the formulation of products. Gemcitabine API Price is not always fixed or binding as the Gemcitabine Price is obtained through a variety of data sources. The Gemcitabine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Gemcitabine

Synonyms

Gemcitabine hcl, 122111-03-9, Gemzar, Ly188011 hydrochloride, Gemcitabine (hydrochloride), 2'-deoxy-2',2'-difluorocytidine monohydrochloride

Cas Number

122111-03-9

Unique Ingredient Identifier (UNII)

U347PV74IL

About Gemcitabine

A deoxycytidine antimetabolite used as an antineoplastic agent.

Gemcitabine Hydrochloride Manufacturers

A Gemcitabine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gemcitabine Hydrochloride, including repackagers and relabelers. The FDA regulates Gemcitabine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gemcitabine Hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Gemcitabine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Gemcitabine Hydrochloride Suppliers

A Gemcitabine Hydrochloride supplier is an individual or a company that provides Gemcitabine Hydrochloride active pharmaceutical ingredient (API) or Gemcitabine Hydrochloride finished formulations upon request. The Gemcitabine Hydrochloride suppliers may include Gemcitabine Hydrochloride API manufacturers, exporters, distributors and traders.

click here to find a list of Gemcitabine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Gemcitabine Hydrochloride CEP

A Gemcitabine Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Gemcitabine Hydrochloride Certificate of Suitability (COS). The purpose of a Gemcitabine Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Gemcitabine Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Gemcitabine Hydrochloride to their clients by showing that a Gemcitabine Hydrochloride CEP has been issued for it. The manufacturer submits a Gemcitabine Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Gemcitabine Hydrochloride CEP holder for the record. Additionally, the data presented in the Gemcitabine Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Gemcitabine Hydrochloride DMF.

A Gemcitabine Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Gemcitabine Hydrochloride CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Gemcitabine Hydrochloride suppliers with CEP (COS) on PharmaCompass.

Gemcitabine Hydrochloride Manufacturers | Traders | Suppliers

Gemcitabine Hydrochloride Manufacturers, Traders, Suppliers 1
Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
Ask Us for Pharmaceutical Supplier and Partner
Ask Us, Find A Supplier / Partner
No Commissions, No Strings Attached, Get Connected for FREE

What are you looking for?

How can we help you?

The request can't be empty

Please read our Privacy Policy carefully

You must agree to the privacy policy

The name can't be empty
The company can't be empty.
The email can't be empty Please enter a valid email.
The mobile can't be empty
Post Enquiry
POST ENQUIRY