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Rochem International Inc
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ABOUT THIS PAGE
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PharmaCompass offers a list of Hemin 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 Hemin manufacturer or Hemin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Hemin manufacturer or Hemin supplier.
PharmaCompass also assists you with knowing the Hemin API Price utilized in the formulation of products. Hemin API Price is not always fixed or binding as the Hemin Price is obtained through a variety of data sources. The Hemin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Hemin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hemin, including repackagers and relabelers. The FDA regulates Hemin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hemin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Hemin supplier is an individual or a company that provides Hemin active pharmaceutical ingredient (API) or Hemin finished formulations upon request. The Hemin suppliers may include Hemin API manufacturers, exporters, distributors and traders.
click here to find a list of Hemin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Hemin DMF (Drug Master File) is a document detailing the whole manufacturing process of Hemin active pharmaceutical ingredient (API) in detail. Different forms of Hemin DMFs exist exist since differing nations have different regulations, such as Hemin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hemin DMF submitted to regulatory agencies in the US is known as a USDMF. Hemin USDMF includes data on Hemin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hemin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hemin 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 Hemin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Hemin 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 Hemin 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 Hemin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Hemin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Hemin suppliers with NDC on PharmaCompass.
Hemin 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 Hemin 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 Hemin GMP manufacturer or Hemin GMP API supplier for your needs.
A Hemin CoA (Certificate of Analysis) is a formal document that attests to Hemin's compliance with Hemin specifications and serves as a tool for batch-level quality control.
Hemin CoA mostly includes findings from lab analyses of a specific batch. For each Hemin 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.
Hemin may be tested according to a variety of international standards, such as European Pharmacopoeia (Hemin EP), Hemin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Hemin USP).
