Synopsis
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CEP/COS
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JDMF
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KDMF
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VMF
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Canada
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Australia
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South Africa
DRUG PRODUCT COMPOSITIONS0
FDF
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API SUPPLIERS
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USDMF
Coral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
GDUFA
DMF Review : Complete
Rev. Date : 2023-12-20
Pay. Date : 2023-11-22
DMF Number : 38936
Submission : 2023-10-05
Status :
Type : II
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2021-11-05
Pay. Date : 2021-11-02
DMF Number : 24691
Submission : 2011-03-02
Status :
Type : II
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Coral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
Date of Issue : 2025-11-20
Valid Till : 2028-11-19
Written Confirmation Number : WC-0009
Address of the Firm : Plot No. 55, 56 & 57, HSIIDC Industrial Estate, Murthal, Sonipat-131 029, Haryan...
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
Date of Issue : 2025-09-03
Valid Till : 2028-09-02
Written Confirmation Number : WC-0161
Address of the Firm : 385/2, Gram Pigdamber, Rau , Indore-453331, Madhya Pradesh, India
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
Date of Issue : 2022-06-30
Valid Till : 2025-07-02
Written Confirmation Number : WC-0161n
Address of the Firm : PLOT NO.385/2, Gram Pigdamber, Rau , Indore-453331, Madhya Pradesh, India
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Coral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
About the Company : Coral Drugs is a research-based international pharmaceutical company with over 27 years of expertise in manufacturing high-quality, affordable APIs. Headquartered in Delhi, India, ...
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
About the Company : Symbiotec, based in Indore, India, is a leading API manufacturer specializing in cortico-steroids and steroid-hormone APIs since 1995. Focused on R&D, sustainability, and innovatio...
Mesochem is focused on incessant innovation along with the R&D of new APIs.
About the Company : Beijing Mesochem Technology Co. Ltd., located in the Yizhuang National Economic and Technological Development Area, China, manufactures pharmaceutical chemicals, fine chemicals, an...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for pharmaceutical and biotech industries. LGM also operates as a full-service CDMO, offering formulat...
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
About the Company : Gonane Pharma is a contract pharmaceutical company based in Gujarat, India, specializing in the manufacturing and marketing of corticosteroids, hormones, antivirals, and oncology p...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and r...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
Human Pharmalabs manufacturer of high quality corticosteroid APIs with a state of the art facility in Kalol Gandhinagar.
About the Company : Human Pharmalabs Pvt. Ltd. was founded to manufacture lifesaving critical APIs in India, pioneering the introduction of Corticosteroid APIs. The company adheres to international st...
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API Imports and Exports
Drugs in Development
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DOSAGE - TABLET;ORAL - 18MG
USFDA APPLICATION NUMBER - 208684
DOSAGE - TABLET;ORAL - 30MG
USFDA APPLICATION NUMBER - 208684
DOSAGE - TABLET;ORAL - 36MG
USFDA APPLICATION NUMBER - 208684
DOSAGE - TABLET;ORAL - 6MG
USFDA APPLICATION NUMBER - 208684
DOSAGE - SUSPENSION;ORAL - 22.75MG/ML
USFDA APPLICATION NUMBER - 208685
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Deflazacort 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 Deflazacort manufacturer or Deflazacort supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Deflazacort manufacturer or Deflazacort supplier.
PharmaCompass also assists you with knowing the Deflazacort API Price utilized in the formulation of products. Deflazacort API Price is not always fixed or binding as the Deflazacort Price is obtained through a variety of data sources. The Deflazacort Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Deflazacortum manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Deflazacortum, including repackagers and relabelers. The FDA regulates Deflazacortum manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Deflazacortum 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 Deflazacortum manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Deflazacortum supplier is an individual or a company that provides Deflazacortum active pharmaceutical ingredient (API) or Deflazacortum finished formulations upon request. The Deflazacortum suppliers may include Deflazacortum API manufacturers, exporters, distributors and traders.
click here to find a list of Deflazacortum suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Deflazacortum DMF (Drug Master File) is a document detailing the whole manufacturing process of Deflazacortum active pharmaceutical ingredient (API) in detail. Different forms of Deflazacortum DMFs exist exist since differing nations have different regulations, such as Deflazacortum USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Deflazacortum DMF submitted to regulatory agencies in the US is known as a USDMF. Deflazacortum USDMF includes data on Deflazacortum's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Deflazacortum USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Deflazacortum suppliers with USDMF on PharmaCompass.
A Deflazacortum written confirmation (Deflazacortum WC) is an official document issued by a regulatory agency to a Deflazacortum manufacturer, verifying that the manufacturing facility of a Deflazacortum active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Deflazacortum APIs or Deflazacortum finished pharmaceutical products to another nation, regulatory agencies frequently require a Deflazacortum WC (written confirmation) as part of the regulatory process.
click here to find a list of Deflazacortum 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 Deflazacortum as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Deflazacortum 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 Deflazacortum 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 Deflazacortum and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Deflazacortum NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Deflazacortum suppliers with NDC on PharmaCompass.
Deflazacortum 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 Deflazacortum 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 Deflazacortum GMP manufacturer or Deflazacortum GMP API supplier for your needs.
A Deflazacortum CoA (Certificate of Analysis) is a formal document that attests to Deflazacortum's compliance with Deflazacortum specifications and serves as a tool for batch-level quality control.
Deflazacortum CoA mostly includes findings from lab analyses of a specific batch. For each Deflazacortum 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.
Deflazacortum may be tested according to a variety of international standards, such as European Pharmacopoeia (Deflazacortum EP), Deflazacortum JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Deflazacortum USP).
