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API SUPPLIERS
IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
JDMF
KDMF
Jai Radhe Sales is your partner for all your sourcing needs.
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
Together we can improve the quality of life
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USDMF
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IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
Cinchocaine Hydrochloride, Micronised And Non-mi...
Certificate Number : CEP 2007-117 - Rev 03
Status : Valid
Issue Date : 2025-04-16
Type : Chemical
Substance Number : 1088
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IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
Japanese Pharmacopoeia Dibucaine Hydrochloride (for manufacturing purposes only)
Registration Number : 218MF10076
Registrant's Address : 57, rue Gravetel St Pierre Les Elbeuf France
Initial Date of Registration : 2006-01-27
Latest Date of Registration : 2013-08-23
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IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
Registrant Name : Daeshin Pharmaceutical Co., Ltd.
Registration Date : 2025-09-05
Registration Number : 20250905-211-J-2013
Manufacturer Name : Pharmasynthese
Manufacturer Address : 57 Rue Gravetel, Saint-Pierre les Elbeuf, 76320, France
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INTERMEDIATE SUPPLIERS
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Deregistered
Registration Country : Sweden
Cinchocaine Hydrochloride; Esculin; Framycetin Sulfate; Hydrocortisone
Brand Name : Proctosedyl
Dosage Form : Rectal Ointment
Dosage Strength :
Packaging :
Approval Date : 29/05/1962
Application Number : 19620529000039
Regulatory Info : Deregistered
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Deregistered
Registration Country : Sweden
Cinchocaine Hydrochloride; Esculin; Framycetin Sulfate; Hydrocortisone
Brand Name : Proctosedyl
Dosage Form : Suppository
Dosage Strength :
Packaging :
Approval Date : 29/05/1962
Application Number : 19620529000046
Regulatory Info : Deregistered
Registration Country : Sweden
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PharmaCompass offers a list of Cinchocaine Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Cinchocaine Hydrochloride manufacturer or Cinchocaine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cinchocaine Hydrochloride manufacturer or Cinchocaine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Cinchocaine Hydrochloride API Price utilized in the formulation of products. Cinchocaine Hydrochloride API Price is not always fixed or binding as the Cinchocaine Hydrochloride Price is obtained through a variety of data sources. The Cinchocaine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Dibucaine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dibucaine Hydrochloride, including repackagers and relabelers. The FDA regulates Dibucaine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dibucaine 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 Dibucaine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dibucaine Hydrochloride supplier is an individual or a company that provides Dibucaine Hydrochloride active pharmaceutical ingredient (API) or Dibucaine Hydrochloride finished formulations upon request. The Dibucaine Hydrochloride suppliers may include Dibucaine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Dibucaine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dibucaine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Dibucaine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Dibucaine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Dibucaine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dibucaine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Dibucaine Hydrochloride USDMF includes data on Dibucaine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dibucaine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dibucaine 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 Dibucaine Hydrochloride Drug Master File in Japan (Dibucaine Hydrochloride JDMF) empowers Dibucaine 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 Dibucaine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Dibucaine 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 Dibucaine 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 Dibucaine Hydrochloride Drug Master File in Korea (Dibucaine Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dibucaine Hydrochloride. The MFDS reviews the Dibucaine Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Dibucaine Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dibucaine 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 Dibucaine Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Dibucaine Hydrochloride suppliers with KDMF on PharmaCompass.
A Dibucaine Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Dibucaine Hydrochloride Certificate of Suitability (COS). The purpose of a Dibucaine Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dibucaine Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dibucaine Hydrochloride to their clients by showing that a Dibucaine Hydrochloride CEP has been issued for it. The manufacturer submits a Dibucaine Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dibucaine Hydrochloride CEP holder for the record. Additionally, the data presented in the Dibucaine Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dibucaine Hydrochloride DMF.
A Dibucaine Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dibucaine 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 Dibucaine Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Dibucaine Hydrochloride written confirmation (Dibucaine Hydrochloride WC) is an official document issued by a regulatory agency to a Dibucaine Hydrochloride manufacturer, verifying that the manufacturing facility of a Dibucaine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dibucaine Hydrochloride APIs or Dibucaine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Dibucaine Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Dibucaine Hydrochloride 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 Dibucaine Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dibucaine 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 Dibucaine 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 Dibucaine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dibucaine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dibucaine Hydrochloride suppliers with NDC on PharmaCompass.
Dibucaine 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 Dibucaine 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 Dibucaine Hydrochloride GMP manufacturer or Dibucaine Hydrochloride GMP API supplier for your needs.
A Dibucaine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Dibucaine Hydrochloride's compliance with Dibucaine Hydrochloride specifications and serves as a tool for batch-level quality control.
Dibucaine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Dibucaine 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.
Dibucaine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Dibucaine Hydrochloride EP), Dibucaine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dibucaine Hydrochloride USP).
