Synopsis
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CEP/COS
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JDMF
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EU WC
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KDMF
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VMF
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FDF
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South Africa
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Listed Dossiers
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API SUPPLIERS
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Temad- We think of world-class quality.
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
NDC 
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USDMF
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
About the Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs)...
Temad- We think of world-class quality.
About the Company : Established in 1997, Temad Co. is one of the largest producers of APIs in Iran & an innovative manufacturer of narcotic and non-narcotic products of world-class quality in the Midd...
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
About the Company : Rusan Pharma is a fully integrated global pharmaceutical company specializing in the treatment of addiction & pain management. We manufacture & market a wide range of APIs & formul...
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API Imports and Exports
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Drugs in Development
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Methylnaltrexone Bromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Methylnaltrexone Bromide, including repackagers and relabelers. The FDA regulates Methylnaltrexone Bromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Methylnaltrexone Bromide 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 Methylnaltrexone Bromide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Methylnaltrexone Bromide supplier is an individual or a company that provides Methylnaltrexone Bromide active pharmaceutical ingredient (API) or Methylnaltrexone Bromide finished formulations upon request. The Methylnaltrexone Bromide suppliers may include Methylnaltrexone Bromide API manufacturers, exporters, distributors and traders.
click here to find a list of Methylnaltrexone Bromide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Methylnaltrexone Bromide DMF (Drug Master File) is a document detailing the whole manufacturing process of Methylnaltrexone Bromide active pharmaceutical ingredient (API) in detail. Different forms of Methylnaltrexone Bromide DMFs exist exist since differing nations have different regulations, such as Methylnaltrexone Bromide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Methylnaltrexone Bromide DMF submitted to regulatory agencies in the US is known as a USDMF. Methylnaltrexone Bromide USDMF includes data on Methylnaltrexone Bromide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Methylnaltrexone Bromide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Methylnaltrexone Bromide 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 Methylnaltrexone Bromide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Methylnaltrexone Bromide 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 Methylnaltrexone Bromide 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 Methylnaltrexone Bromide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Methylnaltrexone Bromide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Methylnaltrexone Bromide suppliers with NDC on PharmaCompass.
Methylnaltrexone Bromide 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 Methylnaltrexone Bromide 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 Methylnaltrexone Bromide GMP manufacturer or Methylnaltrexone Bromide GMP API supplier for your needs.
A Methylnaltrexone Bromide CoA (Certificate of Analysis) is a formal document that attests to Methylnaltrexone Bromide's compliance with Methylnaltrexone Bromide specifications and serves as a tool for batch-level quality control.
Methylnaltrexone Bromide CoA mostly includes findings from lab analyses of a specific batch. For each Methylnaltrexone Bromide 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.
Methylnaltrexone Bromide may be tested according to a variety of international standards, such as European Pharmacopoeia (Methylnaltrexone Bromide EP), Methylnaltrexone Bromide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Methylnaltrexone Bromide USP).
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