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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
CEP/COS 
NDC
KDMF
Chongqing Sintaho Pharma: A trusted partner globally for chemosynthetic APIs.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
Farmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.
JDMF
EU, RU
TAPI offers customized CDMO Solutions for API development and manufacturing services.
ASMF
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
CEP/COS
NDC
KDMF
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USDMF
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-09
Pay. Date : 2013-09-23
DMF Number : 23417
Submission : 2009-12-28
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2021-01-19
Pay. Date : 2020-12-04
DMF Number : 34754
Submission : 2020-03-27
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24388
Submission : 2010-11-23
Status :
Type : II
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API Imports and Exports
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INTERMEDIATES SUPPLIERS
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DOSAGE - SOLUTION;INTRAVENOUS - EQ 100MG/10ML...DOSAGE - SOLUTION;INTRAVENOUS - EQ 100MG/10ML BASE (10MG/ML)
USFDA APPLICATION NUMBER - 215179
DOSAGE - SOLUTION;INTRAVENOUS - EQ 1GM/100ML ...DOSAGE - SOLUTION;INTRAVENOUS - EQ 1GM/100ML BASE (10MG/ML)
USFDA APPLICATION NUMBER - 215179
DOSAGE - SOLUTION;INTRAVENOUS - EQ 500MG/50ML...DOSAGE - SOLUTION;INTRAVENOUS - EQ 500MG/50ML BASE (10MG/ML)
USFDA APPLICATION NUMBER - 215179
Related Excipient Companies
Rochem International Inc
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
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Chewable & Orodispersible Aids
Taste Masking
Direct Compression
Parenteral
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Granulation
Disintegrants & Superdisintegrants
API Stability Enhancers
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Pemetrexed Disodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pemetrexed Disodium, including repackagers and relabelers. The FDA regulates Pemetrexed Disodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pemetrexed Disodium 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 Pemetrexed Disodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pemetrexed Disodium supplier is an individual or a company that provides Pemetrexed Disodium active pharmaceutical ingredient (API) or Pemetrexed Disodium finished formulations upon request. The Pemetrexed Disodium suppliers may include Pemetrexed Disodium API manufacturers, exporters, distributors and traders.
click here to find a list of Pemetrexed Disodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pemetrexed Disodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Pemetrexed Disodium active pharmaceutical ingredient (API) in detail. Different forms of Pemetrexed Disodium DMFs exist exist since differing nations have different regulations, such as Pemetrexed Disodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pemetrexed Disodium DMF submitted to regulatory agencies in the US is known as a USDMF. Pemetrexed Disodium USDMF includes data on Pemetrexed Disodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pemetrexed Disodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pemetrexed Disodium 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 Pemetrexed Disodium Drug Master File in Japan (Pemetrexed Disodium JDMF) empowers Pemetrexed Disodium 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 Pemetrexed Disodium JDMF during the approval evaluation for pharmaceutical products. At the time of Pemetrexed Disodium 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 Pemetrexed Disodium 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 Pemetrexed Disodium Drug Master File in Korea (Pemetrexed Disodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Pemetrexed Disodium. The MFDS reviews the Pemetrexed Disodium KDMF as part of the drug registration process and uses the information provided in the Pemetrexed Disodium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Pemetrexed Disodium 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 Pemetrexed Disodium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Pemetrexed Disodium suppliers with KDMF on PharmaCompass.
A Pemetrexed Disodium CEP of the European Pharmacopoeia monograph is often referred to as a Pemetrexed Disodium Certificate of Suitability (COS). The purpose of a Pemetrexed Disodium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Pemetrexed Disodium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Pemetrexed Disodium to their clients by showing that a Pemetrexed Disodium CEP has been issued for it. The manufacturer submits a Pemetrexed Disodium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Pemetrexed Disodium CEP holder for the record. Additionally, the data presented in the Pemetrexed Disodium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Pemetrexed Disodium DMF.
A Pemetrexed Disodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Pemetrexed Disodium 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 Pemetrexed Disodium suppliers with CEP (COS) on PharmaCompass.
A Pemetrexed Disodium written confirmation (Pemetrexed Disodium WC) is an official document issued by a regulatory agency to a Pemetrexed Disodium manufacturer, verifying that the manufacturing facility of a Pemetrexed Disodium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Pemetrexed Disodium APIs or Pemetrexed Disodium finished pharmaceutical products to another nation, regulatory agencies frequently require a Pemetrexed Disodium WC (written confirmation) as part of the regulatory process.
click here to find a list of Pemetrexed Disodium 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 Pemetrexed Disodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Pemetrexed Disodium 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 Pemetrexed Disodium 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 Pemetrexed Disodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pemetrexed Disodium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Pemetrexed Disodium suppliers with NDC on PharmaCompass.
Pemetrexed Disodium 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 Pemetrexed Disodium 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 Pemetrexed Disodium GMP manufacturer or Pemetrexed Disodium GMP API supplier for your needs.
A Pemetrexed Disodium CoA (Certificate of Analysis) is a formal document that attests to Pemetrexed Disodium's compliance with Pemetrexed Disodium specifications and serves as a tool for batch-level quality control.
Pemetrexed Disodium CoA mostly includes findings from lab analyses of a specific batch. For each Pemetrexed Disodium 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.
Pemetrexed Disodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Pemetrexed Disodium EP), Pemetrexed Disodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pemetrexed Disodium USP).
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