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API SUPPLIERS
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USDMF
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-16
Pay. Date : 2013-07-02
DMF Number : 27125
Submission : 2013-07-03
Status :
Type : II
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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
About the Company : Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in th...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
TAPI offers customized CDMO Solutions for API development and manufacturing services.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
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A Glycerol Phenylbutyrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glycerol Phenylbutyrate, including repackagers and relabelers. The FDA regulates Glycerol Phenylbutyrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glycerol Phenylbutyrate 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 Glycerol Phenylbutyrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Glycerol Phenylbutyrate supplier is an individual or a company that provides Glycerol Phenylbutyrate active pharmaceutical ingredient (API) or Glycerol Phenylbutyrate finished formulations upon request. The Glycerol Phenylbutyrate suppliers may include Glycerol Phenylbutyrate API manufacturers, exporters, distributors and traders.
click here to find a list of Glycerol Phenylbutyrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Glycerol Phenylbutyrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Glycerol Phenylbutyrate active pharmaceutical ingredient (API) in detail. Different forms of Glycerol Phenylbutyrate DMFs exist exist since differing nations have different regulations, such as Glycerol Phenylbutyrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Glycerol Phenylbutyrate DMF submitted to regulatory agencies in the US is known as a USDMF. Glycerol Phenylbutyrate USDMF includes data on Glycerol Phenylbutyrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Glycerol Phenylbutyrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Glycerol Phenylbutyrate suppliers with USDMF on PharmaCompass.
A Glycerol Phenylbutyrate written confirmation (Glycerol Phenylbutyrate WC) is an official document issued by a regulatory agency to a Glycerol Phenylbutyrate manufacturer, verifying that the manufacturing facility of a Glycerol Phenylbutyrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Glycerol Phenylbutyrate APIs or Glycerol Phenylbutyrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Glycerol Phenylbutyrate WC (written confirmation) as part of the regulatory process.
click here to find a list of Glycerol Phenylbutyrate suppliers with Written Confirmation (WC) 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 Glycerol Phenylbutyrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Glycerol Phenylbutyrate 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 Glycerol Phenylbutyrate 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 Glycerol Phenylbutyrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Glycerol Phenylbutyrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Glycerol Phenylbutyrate suppliers with NDC on PharmaCompass.
Glycerol Phenylbutyrate 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 Glycerol Phenylbutyrate 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 Glycerol Phenylbutyrate GMP manufacturer or Glycerol Phenylbutyrate GMP API supplier for your needs.
A Glycerol Phenylbutyrate CoA (Certificate of Analysis) is a formal document that attests to Glycerol Phenylbutyrate's compliance with Glycerol Phenylbutyrate specifications and serves as a tool for batch-level quality control.
Glycerol Phenylbutyrate CoA mostly includes findings from lab analyses of a specific batch. For each Glycerol Phenylbutyrate 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.
Glycerol Phenylbutyrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Glycerol Phenylbutyrate EP), Glycerol Phenylbutyrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Glycerol Phenylbutyrate USP).
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