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API SUPPLIERS
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USDMF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Molindone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Molindone, including repackagers and relabelers. The FDA regulates Molindone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Molindone 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 Molindone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Molindone supplier is an individual or a company that provides Molindone active pharmaceutical ingredient (API) or Molindone finished formulations upon request. The Molindone suppliers may include Molindone API manufacturers, exporters, distributors and traders.
click here to find a list of Molindone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Molindone DMF (Drug Master File) is a document detailing the whole manufacturing process of Molindone active pharmaceutical ingredient (API) in detail. Different forms of Molindone DMFs exist exist since differing nations have different regulations, such as Molindone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Molindone DMF submitted to regulatory agencies in the US is known as a USDMF. Molindone USDMF includes data on Molindone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Molindone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Molindone 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 Molindone as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Molindone 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 Molindone 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 Molindone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Molindone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Molindone suppliers with NDC on PharmaCompass.
Molindone 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 Molindone 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 Molindone GMP manufacturer or Molindone GMP API supplier for your needs.
A Molindone CoA (Certificate of Analysis) is a formal document that attests to Molindone's compliance with Molindone specifications and serves as a tool for batch-level quality control.
Molindone CoA mostly includes findings from lab analyses of a specific batch. For each Molindone 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.
Molindone may be tested according to a variety of international standards, such as European Pharmacopoeia (Molindone EP), Molindone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Molindone USP).
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