Synopsis
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CEP/COS
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JDMF
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EU WC
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KDMF
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VMF
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Canada
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Australia
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South Africa
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Listed Dossiers
DRUG PRODUCT COMPOSITIONS
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
Comhony Biotech manufactures fermentation & semi-synthetic APIs which aim at dermatology, anti-biotics; mitochondria & memory health.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
Sumar Biotech work together to Innovate & Manufacture Semi-synthetic, Synthetic & Fermentation API.
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USDMF
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API Imports and Exports
Drugs in Development
Lead Product(s) : Dalbavancin
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
DALVANCE FDA Approval Acute Bacterial Skin Structure Infections in Pediatric
Details : The 5 patients in the age group birth to less than 3 months of age were not included in the efficacy analyses since they were enrolled with expanded inclusion criteria and only received the single-dose DALVANCE regimen.
Product Name : Dalvance
Product Type : Peptide
Upfront Cash : Inapplicable
July 23, 2021
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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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Direct Compression
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Dalbavancin 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 Dalbavancin manufacturer or Dalbavancin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dalbavancin manufacturer or Dalbavancin supplier.
PharmaCompass also assists you with knowing the Dalbavancin API Price utilized in the formulation of products. Dalbavancin API Price is not always fixed or binding as the Dalbavancin Price is obtained through a variety of data sources. The Dalbavancin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Zeven manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zeven, including repackagers and relabelers. The FDA regulates Zeven manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zeven 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 Zeven manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Zeven supplier is an individual or a company that provides Zeven active pharmaceutical ingredient (API) or Zeven finished formulations upon request. The Zeven suppliers may include Zeven API manufacturers, exporters, distributors and traders.
click here to find a list of Zeven suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Zeven DMF (Drug Master File) is a document detailing the whole manufacturing process of Zeven active pharmaceutical ingredient (API) in detail. Different forms of Zeven DMFs exist exist since differing nations have different regulations, such as Zeven USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Zeven DMF submitted to regulatory agencies in the US is known as a USDMF. Zeven USDMF includes data on Zeven's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Zeven USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Zeven suppliers with USDMF 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 Zeven as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Zeven 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 Zeven 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 Zeven and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Zeven NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Zeven suppliers with NDC on PharmaCompass.
Zeven 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 Zeven 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 Zeven GMP manufacturer or Zeven GMP API supplier for your needs.
A Zeven CoA (Certificate of Analysis) is a formal document that attests to Zeven's compliance with Zeven specifications and serves as a tool for batch-level quality control.
Zeven CoA mostly includes findings from lab analyses of a specific batch. For each Zeven 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.
Zeven may be tested according to a variety of international standards, such as European Pharmacopoeia (Zeven EP), Zeven JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Zeven USP).
