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