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Rochem International Inc
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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 Dalvance manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dalvance, including repackagers and relabelers. The FDA regulates Dalvance manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dalvance 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 Dalvance manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dalvance supplier is an individual or a company that provides Dalvance active pharmaceutical ingredient (API) or Dalvance finished formulations upon request. The Dalvance suppliers may include Dalvance API manufacturers, exporters, distributors and traders.
click here to find a list of Dalvance suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dalvance DMF (Drug Master File) is a document detailing the whole manufacturing process of Dalvance active pharmaceutical ingredient (API) in detail. Different forms of Dalvance DMFs exist exist since differing nations have different regulations, such as Dalvance USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dalvance DMF submitted to regulatory agencies in the US is known as a USDMF. Dalvance USDMF includes data on Dalvance's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dalvance USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dalvance 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 Dalvance as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dalvance 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 Dalvance 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 Dalvance and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dalvance NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dalvance suppliers with NDC on PharmaCompass.
Dalvance 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 Dalvance 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 Dalvance GMP manufacturer or Dalvance GMP API supplier for your needs.
A Dalvance CoA (Certificate of Analysis) is a formal document that attests to Dalvance's compliance with Dalvance specifications and serves as a tool for batch-level quality control.
Dalvance CoA mostly includes findings from lab analyses of a specific batch. For each Dalvance 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.
Dalvance may be tested according to a variety of international standards, such as European Pharmacopoeia (Dalvance EP), Dalvance JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dalvance USP).
