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ABOUT THIS PAGE
A Carteolol Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Carteolol Hydrochloride, including repackagers and relabelers. The FDA regulates Carteolol Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Carteolol 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 Carteolol Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Carteolol Hydrochloride supplier is an individual or a company that provides Carteolol Hydrochloride active pharmaceutical ingredient (API) or Carteolol Hydrochloride finished formulations upon request. The Carteolol Hydrochloride suppliers may include Carteolol Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Carteolol Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Carteolol Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Carteolol Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Carteolol Hydrochloride DMFs exist exist since differing nations have different regulations, such as Carteolol Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Carteolol Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Carteolol Hydrochloride USDMF includes data on Carteolol Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Carteolol Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Carteolol Hydrochloride suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Carteolol Hydrochloride Drug Master File in Japan (Carteolol Hydrochloride JDMF) empowers Carteolol Hydrochloride API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Carteolol Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Carteolol Hydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Carteolol Hydrochloride suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Carteolol Hydrochloride Drug Master File in Korea (Carteolol Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Carteolol Hydrochloride. The MFDS reviews the Carteolol Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Carteolol Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Carteolol Hydrochloride KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Carteolol Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Carteolol Hydrochloride suppliers with KDMF on PharmaCompass.
A Carteolol Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Carteolol Hydrochloride Certificate of Suitability (COS). The purpose of a Carteolol Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Carteolol Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Carteolol Hydrochloride to their clients by showing that a Carteolol Hydrochloride CEP has been issued for it. The manufacturer submits a Carteolol Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Carteolol Hydrochloride CEP holder for the record. Additionally, the data presented in the Carteolol Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Carteolol Hydrochloride DMF.
A Carteolol Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Carteolol 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 Carteolol 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 Carteolol Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Carteolol 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 Carteolol 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 Carteolol Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Carteolol Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Carteolol Hydrochloride suppliers with NDC on PharmaCompass.
Carteolol 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 Carteolol 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 Carteolol Hydrochloride GMP manufacturer or Carteolol Hydrochloride GMP API supplier for your needs.
A Carteolol Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Carteolol Hydrochloride's compliance with Carteolol Hydrochloride specifications and serves as a tool for batch-level quality control.
Carteolol Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Carteolol 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.
Carteolol Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Carteolol Hydrochloride EP), Carteolol Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Carteolol Hydrochloride USP).
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