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DOSAGE - SOLUTION;NASAL - 4%
USFDA APPLICATION NUMBER - 209575
DOSAGE - SOLUTION;NASAL - 4%
USFDA APPLICATION NUMBER - 209963
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ABOUT THIS PAGE
A Cocaine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cocaine Hydrochloride, including repackagers and relabelers. The FDA regulates Cocaine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cocaine Hydrochloride 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 Cocaine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cocaine Hydrochloride supplier is an individual or a company that provides Cocaine Hydrochloride active pharmaceutical ingredient (API) or Cocaine Hydrochloride finished formulations upon request. The Cocaine Hydrochloride suppliers may include Cocaine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Cocaine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cocaine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Cocaine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Cocaine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Cocaine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cocaine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Cocaine Hydrochloride USDMF includes data on Cocaine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cocaine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cocaine Hydrochloride suppliers with USDMF on PharmaCompass.
A Cocaine Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Cocaine Hydrochloride Certificate of Suitability (COS). The purpose of a Cocaine Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cocaine Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cocaine Hydrochloride to their clients by showing that a Cocaine Hydrochloride CEP has been issued for it. The manufacturer submits a Cocaine Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cocaine Hydrochloride CEP holder for the record. Additionally, the data presented in the Cocaine Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cocaine Hydrochloride DMF.
A Cocaine Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cocaine Hydrochloride 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 Cocaine Hydrochloride suppliers with CEP (COS) 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 Cocaine Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cocaine Hydrochloride 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 Cocaine Hydrochloride 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 Cocaine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cocaine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cocaine Hydrochloride suppliers with NDC on PharmaCompass.
Cocaine Hydrochloride 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 Cocaine Hydrochloride 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 Cocaine Hydrochloride GMP manufacturer or Cocaine Hydrochloride GMP API supplier for your needs.
A Cocaine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Cocaine Hydrochloride's compliance with Cocaine Hydrochloride specifications and serves as a tool for batch-level quality control.
Cocaine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Cocaine Hydrochloride 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.
Cocaine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Cocaine Hydrochloride EP), Cocaine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cocaine Hydrochloride USP).
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