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KDMF
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Australia
DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
Aspen API. More than just an API™
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-13
Pay. Date : 2013-08-01
DMF Number : 7197
Submission : 1987-10-28
Status :
Type : II
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28124
Submission : 2014-03-17
Status :
Type : II
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Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
Date of Issue : 2022-08-31
Valid Till : 2025-07-02
Written Confirmation Number : WC-0162A2
Address of the Firm : Plot No. 5, 6, 7 & 8 Special Economic Zone, Phase II, Pithampur, Dist: Dhar, MP-...
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
Date of Issue : 2022-07-05
Valid Till : 2025-07-02
Written Confirmation Number : WC-0161A2
Address of the Firm : 385/2, Pigdamber, Rau, Indore-453 331, MP, India
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
Date of Issue : 2022-09-30
Valid Till : 2025-07-02
Written Confirmation Number : WC-0162A2
Address of the Firm : 385/2, Pigdamber, Rau, Indore-453 331, MP, India
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
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DOSAGE - TABLET;ORAL-21 - 0.15MG;0.03MG **Fed...DOSAGE - TABLET;ORAL-21 - 0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20301
DOSAGE - TABLET;ORAL-28 - 0.1MG,0.125MG,0.15M...DOSAGE - TABLET;ORAL-28 - 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG
USFDA APPLICATION NUMBER - 21090
Digital Content
NEWS #PharmaBuzz
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Desogestrel 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 Desogestrel manufacturer or Desogestrel supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Desogestrel manufacturer or Desogestrel supplier.
PharmaCompass also assists you with knowing the Desogestrel API Price utilized in the formulation of products. Desogestrel API Price is not always fixed or binding as the Desogestrel Price is obtained through a variety of data sources. The Desogestrel Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Cerazette manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cerazette, including repackagers and relabelers. The FDA regulates Cerazette manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cerazette 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 Cerazette manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cerazette supplier is an individual or a company that provides Cerazette active pharmaceutical ingredient (API) or Cerazette finished formulations upon request. The Cerazette suppliers may include Cerazette API manufacturers, exporters, distributors and traders.
click here to find a list of Cerazette suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cerazette DMF (Drug Master File) is a document detailing the whole manufacturing process of Cerazette active pharmaceutical ingredient (API) in detail. Different forms of Cerazette DMFs exist exist since differing nations have different regulations, such as Cerazette USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cerazette DMF submitted to regulatory agencies in the US is known as a USDMF. Cerazette USDMF includes data on Cerazette's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cerazette USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cerazette 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 Cerazette Drug Master File in Japan (Cerazette JDMF) empowers Cerazette 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 Cerazette JDMF during the approval evaluation for pharmaceutical products. At the time of Cerazette 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 Cerazette suppliers with JDMF on PharmaCompass.
A Cerazette CEP of the European Pharmacopoeia monograph is often referred to as a Cerazette Certificate of Suitability (COS). The purpose of a Cerazette CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cerazette EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cerazette to their clients by showing that a Cerazette CEP has been issued for it. The manufacturer submits a Cerazette CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cerazette CEP holder for the record. Additionally, the data presented in the Cerazette CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cerazette DMF.
A Cerazette CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cerazette 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 Cerazette suppliers with CEP (COS) on PharmaCompass.
A Cerazette written confirmation (Cerazette WC) is an official document issued by a regulatory agency to a Cerazette manufacturer, verifying that the manufacturing facility of a Cerazette active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cerazette APIs or Cerazette finished pharmaceutical products to another nation, regulatory agencies frequently require a Cerazette WC (written confirmation) as part of the regulatory process.
click here to find a list of Cerazette 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 Cerazette as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cerazette 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 Cerazette 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 Cerazette and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cerazette NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cerazette suppliers with NDC on PharmaCompass.
Cerazette 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 Cerazette 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 Cerazette GMP manufacturer or Cerazette GMP API supplier for your needs.
A Cerazette CoA (Certificate of Analysis) is a formal document that attests to Cerazette's compliance with Cerazette specifications and serves as a tool for batch-level quality control.
Cerazette CoA mostly includes findings from lab analyses of a specific batch. For each Cerazette 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.
Cerazette may be tested according to a variety of international standards, such as European Pharmacopoeia (Cerazette EP), Cerazette JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cerazette USP).
