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