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API SUPPLIERS
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USDMF
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2016-06-27
Pay. Date : 2016-06-06
DMF Number : 18857
Submission : 2005-10-11
Status :
Type : II
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : Complete
Rev. Date : 2015-02-20
Pay. Date : 2013-08-20
DMF Number : 27402
Submission : 2014-02-20
Status :
Type : II
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-20
Pay. Date : 2012-12-03
DMF Number : 20979
Submission : 2007-10-29
Status :
Type : II
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Certificate Number : R1-CEP 2007-075 - Rev 06
Status : Valid
Issue Date : 2021-06-18
Type : Chemical
Substance Number : 2306
Farmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.
Certificate Number : R1-CEP 2011-032 - Rev 01
Status : Valid
Issue Date : 2017-09-27
Type : Chemical
Substance Number : 2306
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Drugs in Development
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DOSAGE - INJECTABLE;INJECTION - EQ 1GM BASE/V...DOSAGE - INJECTABLE;INJECTION - EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20509
DOSAGE - INJECTABLE;INJECTION - EQ 200MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20509
DOSAGE - SOLUTION;INTRAVENOUS - EQ 1200MG BAS...DOSAGE - SOLUTION;INTRAVENOUS - EQ 1200MG BASE/120ML (EQ 10MG BASE/ML)
USFDA APPLICATION NUMBER - 208313
DOSAGE - SOLUTION;INTRAVENOUS - EQ 1300MG BAS...DOSAGE - SOLUTION;INTRAVENOUS - EQ 1300MG BASE/130ML (EQ 10MG BASE/ML)
USFDA APPLICATION NUMBER - 208313
DOSAGE - SOLUTION;INTRAVENOUS - EQ 1400MG BAS...DOSAGE - SOLUTION;INTRAVENOUS - EQ 1400MG BASE/140ML (EQ 10MG BASE/ML)
USFDA APPLICATION NUMBER - 208313
DOSAGE - SOLUTION;INTRAVENOUS - EQ 1500MG BAS...DOSAGE - SOLUTION;INTRAVENOUS - EQ 1500MG BASE/150ML (EQ 10MG BASE/ML)
USFDA APPLICATION NUMBER - 208313
DOSAGE - SOLUTION;INTRAVENOUS - EQ 1600MG BAS...DOSAGE - SOLUTION;INTRAVENOUS - EQ 1600MG BASE/160ML (EQ 10MG BASE/ML)
USFDA APPLICATION NUMBER - 208313
DOSAGE - SOLUTION;INTRAVENOUS - EQ 1700MG BAS...DOSAGE - SOLUTION;INTRAVENOUS - EQ 1700MG BASE/170ML (EQ 10MG BASE/ML)
USFDA APPLICATION NUMBER - 208313
DOSAGE - SOLUTION;INTRAVENOUS - EQ 1800MG BAS...DOSAGE - SOLUTION;INTRAVENOUS - EQ 1800MG BASE/180ML (EQ 10MG BASE/ML)
USFDA APPLICATION NUMBER - 208313
DOSAGE - SOLUTION;INTRAVENOUS - EQ 1900MG BAS...DOSAGE - SOLUTION;INTRAVENOUS - EQ 1900MG BASE/190ML (EQ 10MG BASE/ML)
USFDA APPLICATION NUMBER - 208313
DOSAGE - SOLUTION;INTRAVENOUS - EQ 2000MG BAS...DOSAGE - SOLUTION;INTRAVENOUS - EQ 2000MG BASE/200ML (EQ 10MG BASE/ML)
USFDA APPLICATION NUMBER - 208313
DOSAGE - SOLUTION;INTRAVENOUS - EQ 2200MG BAS...DOSAGE - SOLUTION;INTRAVENOUS - EQ 2200MG BASE/220ML (EQ 10MG BASE/ML)
USFDA APPLICATION NUMBER - 208313
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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.
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.
A Gemcitabine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Gemcitabine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Gemcitabine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Gemcitabine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gemcitabine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Gemcitabine Hydrochloride USDMF includes data on Gemcitabine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gemcitabine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gemcitabine Hydrochloride suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Gemcitabine Hydrochloride Drug Master File in Japan (Gemcitabine Hydrochloride JDMF) empowers Gemcitabine Hydrochloride API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Gemcitabine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Gemcitabine Hydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Gemcitabine Hydrochloride suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Gemcitabine Hydrochloride Drug Master File in Korea (Gemcitabine Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Gemcitabine Hydrochloride. The MFDS reviews the Gemcitabine Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Gemcitabine Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Gemcitabine Hydrochloride KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Gemcitabine Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Gemcitabine Hydrochloride suppliers with KDMF on PharmaCompass.
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.
A Gemcitabine Hydrochloride written confirmation (Gemcitabine Hydrochloride WC) is an official document issued by a regulatory agency to a Gemcitabine Hydrochloride manufacturer, verifying that the manufacturing facility of a Gemcitabine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Gemcitabine Hydrochloride APIs or Gemcitabine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Gemcitabine Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Gemcitabine Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Gemcitabine Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Gemcitabine Hydrochloride API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Gemcitabine Hydrochloride as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Gemcitabine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Gemcitabine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Gemcitabine Hydrochloride suppliers with NDC on PharmaCompass.
Gemcitabine Hydrochloride Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Gemcitabine Hydrochloride GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Gemcitabine Hydrochloride GMP manufacturer or Gemcitabine Hydrochloride GMP API supplier for your needs.
A Gemcitabine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Gemcitabine Hydrochloride's compliance with Gemcitabine Hydrochloride specifications and serves as a tool for batch-level quality control.
Gemcitabine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Gemcitabine Hydrochloride CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Gemcitabine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Gemcitabine Hydrochloride EP), Gemcitabine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Gemcitabine Hydrochloride USP).
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