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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
Coral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38283
Submission : 2023-04-08
Status :
Type : II
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23650
Submission : 2010-03-23
Status :
Type : II
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Coral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
Certificate Number : CEP 2022-270 - Rev 00
Status : Valid
Issue Date : 2024-10-31
Type : Chemical
Substance Number : 2703
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
Certificate Number : R1-CEP 2014-090 - Rev 01
Status : Valid
Issue Date : 2022-10-27
Type : Chemical
Substance Number : 2703
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API Imports and Exports
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Drugs in Development
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DOSAGE - AEROSOL, METERED;NASAL - 0.037MG/INH
USFDA APPLICATION NUMBER - 202129
DOSAGE - AEROSOL, METERED;INHALATION - 0.08MG...DOSAGE - AEROSOL, METERED;INHALATION - 0.08MG/INH
USFDA APPLICATION NUMBER - 21658
DOSAGE - AEROSOL, METERED;INHALATION - 0.16MG...DOSAGE - AEROSOL, METERED;INHALATION - 0.16MG/INH
USFDA APPLICATION NUMBER - 21658
DOSAGE - SPRAY, METERED;NASAL - 0.05MG/SPRAY
USFDA APPLICATION NUMBER - 22004
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Ciclesonide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ciclesonide, including repackagers and relabelers. The FDA regulates Ciclesonide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ciclesonide 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 Ciclesonide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ciclesonide supplier is an individual or a company that provides Ciclesonide active pharmaceutical ingredient (API) or Ciclesonide finished formulations upon request. The Ciclesonide suppliers may include Ciclesonide API manufacturers, exporters, distributors and traders.
click here to find a list of Ciclesonide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ciclesonide DMF (Drug Master File) is a document detailing the whole manufacturing process of Ciclesonide active pharmaceutical ingredient (API) in detail. Different forms of Ciclesonide DMFs exist exist since differing nations have different regulations, such as Ciclesonide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ciclesonide DMF submitted to regulatory agencies in the US is known as a USDMF. Ciclesonide USDMF includes data on Ciclesonide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ciclesonide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ciclesonide 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 Ciclesonide Drug Master File in Japan (Ciclesonide JDMF) empowers Ciclesonide 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 Ciclesonide JDMF during the approval evaluation for pharmaceutical products. At the time of Ciclesonide 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 Ciclesonide 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 Ciclesonide Drug Master File in Korea (Ciclesonide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ciclesonide. The MFDS reviews the Ciclesonide KDMF as part of the drug registration process and uses the information provided in the Ciclesonide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ciclesonide 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 Ciclesonide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ciclesonide suppliers with KDMF on PharmaCompass.
A Ciclesonide CEP of the European Pharmacopoeia monograph is often referred to as a Ciclesonide Certificate of Suitability (COS). The purpose of a Ciclesonide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ciclesonide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ciclesonide to their clients by showing that a Ciclesonide CEP has been issued for it. The manufacturer submits a Ciclesonide CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ciclesonide CEP holder for the record. Additionally, the data presented in the Ciclesonide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ciclesonide DMF.
A Ciclesonide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ciclesonide 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 Ciclesonide suppliers with CEP (COS) on PharmaCompass.
A Ciclesonide written confirmation (Ciclesonide WC) is an official document issued by a regulatory agency to a Ciclesonide manufacturer, verifying that the manufacturing facility of a Ciclesonide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ciclesonide APIs or Ciclesonide finished pharmaceutical products to another nation, regulatory agencies frequently require a Ciclesonide WC (written confirmation) as part of the regulatory process.
click here to find a list of Ciclesonide 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 Ciclesonide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ciclesonide 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 Ciclesonide 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 Ciclesonide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ciclesonide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ciclesonide suppliers with NDC on PharmaCompass.
Ciclesonide 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 Ciclesonide 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 Ciclesonide GMP manufacturer or Ciclesonide GMP API supplier for your needs.
A Ciclesonide CoA (Certificate of Analysis) is a formal document that attests to Ciclesonide's compliance with Ciclesonide specifications and serves as a tool for batch-level quality control.
Ciclesonide CoA mostly includes findings from lab analyses of a specific batch. For each Ciclesonide 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.
Ciclesonide may be tested according to a variety of international standards, such as European Pharmacopoeia (Ciclesonide EP), Ciclesonide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ciclesonide USP).
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