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API SUPPLIERS
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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USDMF
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Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Potassium hydrogen carbonate 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 Potassium hydrogen carbonate manufacturer or Potassium hydrogen carbonate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Potassium hydrogen carbonate manufacturer or Potassium hydrogen carbonate supplier.
PharmaCompass also assists you with knowing the Potassium hydrogen carbonate API Price utilized in the formulation of products. Potassium hydrogen carbonate API Price is not always fixed or binding as the Potassium hydrogen carbonate Price is obtained through a variety of data sources. The Potassium hydrogen carbonate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A E-501(II) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of E-501(II), including repackagers and relabelers. The FDA regulates E-501(II) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. E-501(II) 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 E-501(II) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A E-501(II) supplier is an individual or a company that provides E-501(II) active pharmaceutical ingredient (API) or E-501(II) finished formulations upon request. The E-501(II) suppliers may include E-501(II) API manufacturers, exporters, distributors and traders.
click here to find a list of E-501(II) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A E-501(II) DMF (Drug Master File) is a document detailing the whole manufacturing process of E-501(II) active pharmaceutical ingredient (API) in detail. Different forms of E-501(II) DMFs exist exist since differing nations have different regulations, such as E-501(II) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A E-501(II) DMF submitted to regulatory agencies in the US is known as a USDMF. E-501(II) USDMF includes data on E-501(II)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The E-501(II) USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of E-501(II) suppliers with USDMF on PharmaCompass.
E-501(II) 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 E-501(II) 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 E-501(II) GMP manufacturer or E-501(II) GMP API supplier for your needs.
A E-501(II) CoA (Certificate of Analysis) is a formal document that attests to E-501(II)'s compliance with E-501(II) specifications and serves as a tool for batch-level quality control.
E-501(II) CoA mostly includes findings from lab analyses of a specific batch. For each E-501(II) 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.
E-501(II) may be tested according to a variety of international standards, such as European Pharmacopoeia (E-501(II) EP), E-501(II) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (E-501(II) USP).
