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