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JDMF
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EU WC
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NDC API
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VMF
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FDA Orange Book
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Canada
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FDF
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
Jai Radhe Sales is your partner for all your sourcing needs.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
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USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
Certificate Number : CEP 2013-148 - Rev 02
Status : Valid
Issue Date : 2025-07-22
Type : Chemical
Substance Number : 383
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] Listed Suppliers
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
About the Company : Olpha, a subsidiary of JSC AB City, is one of the largest companies in the Baltic states with 50 years of experience in producing medicines and chemical pharmaceuticals. Its portfo...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and r...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
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Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Chlorobutanol Hemihydrate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Chlorobutanol Hemihydrate manufacturer or Chlorobutanol Hemihydrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Chlorobutanol Hemihydrate manufacturer or Chlorobutanol Hemihydrate supplier.
A Clorobutanol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Clorobutanol, including repackagers and relabelers. The FDA regulates Clorobutanol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Clorobutanol 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 Clorobutanol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Clorobutanol supplier is an individual or a company that provides Clorobutanol active pharmaceutical ingredient (API) or Clorobutanol finished formulations upon request. The Clorobutanol suppliers may include Clorobutanol API manufacturers, exporters, distributors and traders.
click here to find a list of Clorobutanol suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Clorobutanol DMF (Drug Master File) is a document detailing the whole manufacturing process of Clorobutanol active pharmaceutical ingredient (API) in detail. Different forms of Clorobutanol DMFs exist exist since differing nations have different regulations, such as Clorobutanol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Clorobutanol DMF submitted to regulatory agencies in the US is known as a USDMF. Clorobutanol USDMF includes data on Clorobutanol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Clorobutanol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Clorobutanol suppliers with USDMF on PharmaCompass.
A Clorobutanol CEP of the European Pharmacopoeia monograph is often referred to as a Clorobutanol Certificate of Suitability (COS). The purpose of a Clorobutanol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Clorobutanol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Clorobutanol to their clients by showing that a Clorobutanol CEP has been issued for it. The manufacturer submits a Clorobutanol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Clorobutanol CEP holder for the record. Additionally, the data presented in the Clorobutanol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Clorobutanol DMF.
A Clorobutanol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Clorobutanol CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Clorobutanol suppliers with CEP (COS) on PharmaCompass.
Clorobutanol 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 Clorobutanol GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Clorobutanol GMP manufacturer or Clorobutanol GMP API supplier for your needs.
A Clorobutanol CoA (Certificate of Analysis) is a formal document that attests to Clorobutanol's compliance with Clorobutanol specifications and serves as a tool for batch-level quality control.
Clorobutanol CoA mostly includes findings from lab analyses of a specific batch. For each Clorobutanol 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.
Clorobutanol may be tested according to a variety of international standards, such as European Pharmacopoeia (Clorobutanol EP), Clorobutanol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Clorobutanol USP).
