Synopsis
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CEP/COS
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JDMF
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EU WC
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VMF
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EDQM
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USP
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JP
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Others
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Australia
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South Africa
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Listed Dossiers
DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38964
Submission : 2023-10-04
Status :
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-08
Pay. Date : 2023-09-28
DMF Number : 38781
Submission : 2023-09-22
Status :
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39823
Submission : 2024-04-30
Status :
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36974
Submission : 2022-05-06
Status :
Type : II
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2024-02-12
Pay. Date : 2024-01-05
DMF Number : 38784
Submission : 2023-09-30
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
About the Company : Transo-Pharm is a licensed distributor of pharmaceutical components for human and veterinary markets. The company supports the full API life cycle, from development to sales, and a...
With Virupaksha, you get a quality product with on-time delivery.
About the Company : Virupaksha Organics, founded in 2003, is a leading manufacturer of APIs and intermediates. Its FDA-audited, ISO-certified facilities in Kazipally and Pashamylaram produce high-qual...
European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
About the Company : Polpharma API, a division of a leading Polish pharmaceutical group, has over 75 years of expertise in process development and cGMP manufacturing. Based at an FDA-approved site in C...
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
About the Company : ChemWerth, established in 1982, is a US-headquartered full-service generic API company. It supplies cGMP-quality APIs to regulated markets worldwide, with exclusive partnerships fo...
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
About the Company : Transo-Pharm, founded in 1987, is a fully licensed global distributor of pharmaceutical components for health and veterinary industries. It supports customers throughout the API li...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : Shanghai Minbiotech is specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square meters of R&D centers in...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
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DOSAGE - CAPSULE;ORAL - 186MG
USFDA APPLICATION NUMBER - 207500
DOSAGE - CAPSULE;ORAL - 74.5MG
USFDA APPLICATION NUMBER - 207500
DOSAGE - POWDER;INTRAVENOUS - 372MG
USFDA APPLICATION NUMBER - 207501
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ABOUT THIS PAGE
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PharmaCompass offers a list of Isavuconazonium Sulfate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Isavuconazonium Sulfate manufacturer or Isavuconazonium Sulfate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Isavuconazonium Sulfate manufacturer or Isavuconazonium Sulfate supplier.
A Isavuconazole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isavuconazole, including repackagers and relabelers. The FDA regulates Isavuconazole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isavuconazole 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 Isavuconazole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Isavuconazole supplier is an individual or a company that provides Isavuconazole active pharmaceutical ingredient (API) or Isavuconazole finished formulations upon request. The Isavuconazole suppliers may include Isavuconazole API manufacturers, exporters, distributors and traders.
click here to find a list of Isavuconazole suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Isavuconazole DMF (Drug Master File) is a document detailing the whole manufacturing process of Isavuconazole active pharmaceutical ingredient (API) in detail. Different forms of Isavuconazole DMFs exist exist since differing nations have different regulations, such as Isavuconazole USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Isavuconazole DMF submitted to regulatory agencies in the US is known as a USDMF. Isavuconazole USDMF includes data on Isavuconazole's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Isavuconazole USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Isavuconazole suppliers with USDMF 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 Isavuconazole Drug Master File in Korea (Isavuconazole KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Isavuconazole. The MFDS reviews the Isavuconazole KDMF as part of the drug registration process and uses the information provided in the Isavuconazole KDMF to evaluate the safety and efficacy of the drug.
After submitting a Isavuconazole 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 Isavuconazole API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Isavuconazole suppliers with KDMF 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 Isavuconazole as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Isavuconazole 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 Isavuconazole 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 Isavuconazole and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Isavuconazole NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Isavuconazole suppliers with NDC on PharmaCompass.
Isavuconazole 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 Isavuconazole GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Isavuconazole GMP manufacturer or Isavuconazole GMP API supplier for your needs.
A Isavuconazole CoA (Certificate of Analysis) is a formal document that attests to Isavuconazole's compliance with Isavuconazole specifications and serves as a tool for batch-level quality control.
Isavuconazole CoA mostly includes findings from lab analyses of a specific batch. For each Isavuconazole 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.
Isavuconazole may be tested according to a variety of international standards, such as European Pharmacopoeia (Isavuconazole EP), Isavuconazole JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Isavuconazole USP).
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