Synopsis
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CEP/COS
0
VMF
0
EDQM
0
USP
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JP
0
Others
0
Australia
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
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KDMF
ASMF
Sumar Biotech work together to Innovate & Manufacture Semi-synthetic, Synthetic & Fermentation API.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
Fishfa Biogenics: Renowned Manufacturer, & Exporter of Tacrolimus & Mupirocin API.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
JDMF
EU-WC
NDC
KDMF
ASMF
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
ASMF
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USDMF
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27585
Submission : 2013-11-27
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-14
Pay. Date : 2013-03-20
DMF Number : 26978
Submission : 2013-06-21
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22770
Submission : 2009-05-12
Status :
Type : II
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
CAS Number : 135575-42-7
End Use API : Caspofungin
About The Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...
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DOSAGE - POWDER;INTRAVENOUS - 50MG/VIAL
USFDA APPLICATION NUMBER - 21227
DOSAGE - POWDER;INTRAVENOUS - 70MG/VIAL
USFDA APPLICATION NUMBER - 21227
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NEWS #PharmaBuzz
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ABOUT THIS PAGE
94
PharmaCompass offers a list of Caspofungin 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 Caspofungin manufacturer or Caspofungin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Caspofungin manufacturer or Caspofungin supplier.
PharmaCompass also assists you with knowing the Caspofungin API Price utilized in the formulation of products. Caspofungin API Price is not always fixed or binding as the Caspofungin Price is obtained through a variety of data sources. The Caspofungin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A MolPort-029-887-122 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of MolPort-029-887-122, including repackagers and relabelers. The FDA regulates MolPort-029-887-122 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. MolPort-029-887-122 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 MolPort-029-887-122 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A MolPort-029-887-122 supplier is an individual or a company that provides MolPort-029-887-122 active pharmaceutical ingredient (API) or MolPort-029-887-122 finished formulations upon request. The MolPort-029-887-122 suppliers may include MolPort-029-887-122 API manufacturers, exporters, distributors and traders.
click here to find a list of MolPort-029-887-122 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A MolPort-029-887-122 DMF (Drug Master File) is a document detailing the whole manufacturing process of MolPort-029-887-122 active pharmaceutical ingredient (API) in detail. Different forms of MolPort-029-887-122 DMFs exist exist since differing nations have different regulations, such as MolPort-029-887-122 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A MolPort-029-887-122 DMF submitted to regulatory agencies in the US is known as a USDMF. MolPort-029-887-122 USDMF includes data on MolPort-029-887-122's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The MolPort-029-887-122 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of MolPort-029-887-122 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 MolPort-029-887-122 Drug Master File in Japan (MolPort-029-887-122 JDMF) empowers MolPort-029-887-122 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 MolPort-029-887-122 JDMF during the approval evaluation for pharmaceutical products. At the time of MolPort-029-887-122 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 MolPort-029-887-122 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 MolPort-029-887-122 Drug Master File in Korea (MolPort-029-887-122 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of MolPort-029-887-122. The MFDS reviews the MolPort-029-887-122 KDMF as part of the drug registration process and uses the information provided in the MolPort-029-887-122 KDMF to evaluate the safety and efficacy of the drug.
After submitting a MolPort-029-887-122 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 MolPort-029-887-122 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of MolPort-029-887-122 suppliers with KDMF on PharmaCompass.
A MolPort-029-887-122 written confirmation (MolPort-029-887-122 WC) is an official document issued by a regulatory agency to a MolPort-029-887-122 manufacturer, verifying that the manufacturing facility of a MolPort-029-887-122 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting MolPort-029-887-122 APIs or MolPort-029-887-122 finished pharmaceutical products to another nation, regulatory agencies frequently require a MolPort-029-887-122 WC (written confirmation) as part of the regulatory process.
click here to find a list of MolPort-029-887-122 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 MolPort-029-887-122 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for MolPort-029-887-122 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 MolPort-029-887-122 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 MolPort-029-887-122 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a MolPort-029-887-122 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of MolPort-029-887-122 suppliers with NDC on PharmaCompass.
MolPort-029-887-122 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 MolPort-029-887-122 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 MolPort-029-887-122 GMP manufacturer or MolPort-029-887-122 GMP API supplier for your needs.
A MolPort-029-887-122 CoA (Certificate of Analysis) is a formal document that attests to MolPort-029-887-122's compliance with MolPort-029-887-122 specifications and serves as a tool for batch-level quality control.
MolPort-029-887-122 CoA mostly includes findings from lab analyses of a specific batch. For each MolPort-029-887-122 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.
MolPort-029-887-122 may be tested according to a variety of international standards, such as European Pharmacopoeia (MolPort-029-887-122 EP), MolPort-029-887-122 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (MolPort-029-887-122 USP).
