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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
JDMF 
NDC
KDMF
ASMF 
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
CEP/COS
JDMF
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
NDC
Axplora- The partner of choice for complex APIs.
EU
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
NDC
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Bioquim: An European GMP-certified company manufacturing bulk APIs, specializing in sterile lyophilization and chemical synthesis.
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USDMF
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
GDUFA
DMF Review : Complete
Rev. Date : 2016-08-04
Pay. Date : 2016-04-08
DMF Number : 30373
Submission : 2016-03-03
Status :
Type : II
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2789
Submission : 1976-11-11
Status :
Type : II
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-26
Pay. Date : 2013-02-13
DMF Number : 1413
Submission : 1969-09-02
Status :
Type : II
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2016-02-09
Pay. Date : 2015-06-09
DMF Number : 29221
Submission : 2015-03-30
Status :
Type : II
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2019-12-27
Pay. Date : 2019-12-03
DMF Number : 31349
Submission : 2017-01-12
Status :
Type : II
Axplora- The partner of choice for complex APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37639
Submission : 2023-01-24
Status :
Type : II
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7416
Submission : 1988-04-04
Status :
Type : II
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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Certificate Number : R1-CEP 1996-052 - Rev 07
Status : Withdrawn by Holder
Issue Date : 2021-12-16
Type : Chemical
Substance Number : 335
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Hydrocortisone, Micronised, Process 2
Certificate Number : R1-CEP 2012-163 - Rev 01
Status : Valid
Issue Date : 2021-12-16
Type : Chemical
Substance Number : 335
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Certificate Number : CEP 2019-166 - Rev 03
Status : Valid
Issue Date : 2024-11-25
Type : Chemical
Substance Number : 335
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
Hydrocortisone, Non-micronised, Micronised
Certificate Number : R1-CEP 2002-220 - Rev 02
Status : Valid
Issue Date : 2023-03-23
Type : Chemical
Substance Number : 335
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
Certificate Number : CEP 2018-054 - Rev 02
Status : Valid
Issue Date : 2024-04-15
Type : Chemical
Substance Number : 335
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Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
Hydrocortisone Hemisuccinate BP/USP, Hydrocortisone BP/EP/USP
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
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
Hydrocortisone Hemisuccinate BP/USP
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 : 2022-07-05
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 : 2022-08-31
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-...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Registrant Name : Novartis Korea Ltd.
Registration Date : 2023-07-25
Registration Number : 20230725-209-J-1524
Manufacturer Name : EUROAPI France
Manufacturer Address : 4 Lieu Dit La Paterie, Vertolaye, 63480, France
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
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API Imports and Exports
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Drugs in Development
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : Flebocortid Richter
Dosage Form : Hydrocortisone 1G 1 Units Parenteral Use
Dosage Strength : 1 bottle EV 1 g + 1 ampoule solv 10 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Proctosedyl
Dosage Form : Rectal Salve
Dosage Strength : (not entered)
Packaging : Tube
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Sweden
Brand Name : Hydrokortison Orion
Dosage Form : TABLETT
Dosage Strength : 10 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Proctosedyl Ointment
Dosage Form : OIN
Dosage Strength : 5mg/g
Packaging : 30X1mg/g
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Proctosedyl Suppositories
Dosage Form : SUP
Dosage Strength : 5mg/g
Packaging : 1X12mg/g
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Dilucort
Dosage Form : CRE
Dosage Strength : 5mg/g
Packaging : 25X1mg/g
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Dilucort
Dosage Form : OIN
Dosage Strength : 5mg/g
Packaging : 25X1mg/g
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Skincalm
Dosage Form : CRE
Dosage Strength : 0.5g/100g
Packaging : 25X1g/100g
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Viocort
Dosage Form : CRE
Dosage Strength : 150mg/5g
Packaging : 20X1mg/5g
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Viocort
Dosage Form : CRE
Dosage Strength : 150mg/5g
Packaging : 500X1mg/5g
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
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Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 20MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Cream
Dosage Strength : 1%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Ointment
Dosage Strength : 1%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.
Regulatory Info :
Registration Country : France
Brand Name :
Dosage Form : Pellets in sachet
Dosage Strength : 1MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : France
Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.
Regulatory Info :
Registration Country : France
Brand Name :
Dosage Form : Pellets in sachet
Dosage Strength : 2.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : France
Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.
Regulatory Info :
Registration Country : France
Brand Name :
Dosage Form : Pellets in sachet
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : France
Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.
Regulatory Info : Dossier Available
Registration Country : Poland
Brand Name :
Dosage Form : Suspension for Cutaneo...
Dosage Strength : 1.372MG/GM
Packaging :
Approval Date :
Application Number :
Regulatory Info : Dossier Available
Registration Country : Poland
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - SUSPENSION/DROPS;OTIC - EQ 0.2% BASE...DOSAGE - SUSPENSION/DROPS;OTIC - EQ 0.2% BASE;1%
USFDA APPLICATION NUMBER - 20805
DOSAGE - CREAM;TOPICAL - 5%;1%
USFDA APPLICATION NUMBER - 22436
DOSAGE - OINTMENT;TOPICAL - 400 UNITS/GM;1%;E...DOSAGE - OINTMENT;TOPICAL - 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50168
DOSAGE - CREAM;TOPICAL - 1%
USFDA APPLICATION NUMBER - 80693
DOSAGE - TABLET;ORAL - 10MG
USFDA APPLICATION NUMBER - 8697
DOSAGE - TABLET;ORAL - 20MG
USFDA APPLICATION NUMBER - 8697
DOSAGE - TABLET;ORAL - 5MG
USFDA APPLICATION NUMBER - 8697
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Direct Compression
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Controlled & Modified Release
Co-Processed Excipients
Film Formers & Plasticizers
Surfactant & Foaming Agents
Taste Masking
Chewable & Orodispersible Aids
Rheology Modifiers
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Soft Gelatin
Digital Content
DATA COMPILATION #PharmaFlow
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REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
BioAnalytical Methods
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ABOUT THIS PAGE
A Hydrocortisone Sodium Phosphate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hydrocortisone Sodium Phosphate, including repackagers and relabelers. The FDA regulates Hydrocortisone Sodium Phosphate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hydrocortisone Sodium Phosphate 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 Hydrocortisone Sodium Phosphate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hydrocortisone Sodium Phosphate supplier is an individual or a company that provides Hydrocortisone Sodium Phosphate active pharmaceutical ingredient (API) or Hydrocortisone Sodium Phosphate finished formulations upon request. The Hydrocortisone Sodium Phosphate suppliers may include Hydrocortisone Sodium Phosphate API manufacturers, exporters, distributors and traders.
click here to find a list of Hydrocortisone Sodium Phosphate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Hydrocortisone Sodium Phosphate DMF (Drug Master File) is a document detailing the whole manufacturing process of Hydrocortisone Sodium Phosphate active pharmaceutical ingredient (API) in detail. Different forms of Hydrocortisone Sodium Phosphate DMFs exist exist since differing nations have different regulations, such as Hydrocortisone Sodium Phosphate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hydrocortisone Sodium Phosphate DMF submitted to regulatory agencies in the US is known as a USDMF. Hydrocortisone Sodium Phosphate USDMF includes data on Hydrocortisone Sodium Phosphate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hydrocortisone Sodium Phosphate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hydrocortisone Sodium Phosphate 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 Hydrocortisone Sodium Phosphate Drug Master File in Japan (Hydrocortisone Sodium Phosphate JDMF) empowers Hydrocortisone Sodium Phosphate 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 Hydrocortisone Sodium Phosphate JDMF during the approval evaluation for pharmaceutical products. At the time of Hydrocortisone Sodium Phosphate 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 Hydrocortisone Sodium Phosphate 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 Hydrocortisone Sodium Phosphate Drug Master File in Korea (Hydrocortisone Sodium Phosphate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Hydrocortisone Sodium Phosphate. The MFDS reviews the Hydrocortisone Sodium Phosphate KDMF as part of the drug registration process and uses the information provided in the Hydrocortisone Sodium Phosphate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Hydrocortisone Sodium Phosphate 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 Hydrocortisone Sodium Phosphate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Hydrocortisone Sodium Phosphate suppliers with KDMF on PharmaCompass.
A Hydrocortisone Sodium Phosphate CEP of the European Pharmacopoeia monograph is often referred to as a Hydrocortisone Sodium Phosphate Certificate of Suitability (COS). The purpose of a Hydrocortisone Sodium Phosphate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Hydrocortisone Sodium Phosphate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Hydrocortisone Sodium Phosphate to their clients by showing that a Hydrocortisone Sodium Phosphate CEP has been issued for it. The manufacturer submits a Hydrocortisone Sodium Phosphate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Hydrocortisone Sodium Phosphate CEP holder for the record. Additionally, the data presented in the Hydrocortisone Sodium Phosphate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Hydrocortisone Sodium Phosphate DMF.
A Hydrocortisone Sodium Phosphate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Hydrocortisone Sodium Phosphate 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 Hydrocortisone Sodium Phosphate suppliers with CEP (COS) on PharmaCompass.
A Hydrocortisone Sodium Phosphate written confirmation (Hydrocortisone Sodium Phosphate WC) is an official document issued by a regulatory agency to a Hydrocortisone Sodium Phosphate manufacturer, verifying that the manufacturing facility of a Hydrocortisone Sodium Phosphate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Hydrocortisone Sodium Phosphate APIs or Hydrocortisone Sodium Phosphate finished pharmaceutical products to another nation, regulatory agencies frequently require a Hydrocortisone Sodium Phosphate WC (written confirmation) as part of the regulatory process.
click here to find a list of Hydrocortisone Sodium Phosphate 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 Hydrocortisone Sodium Phosphate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Hydrocortisone Sodium Phosphate 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 Hydrocortisone Sodium Phosphate 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 Hydrocortisone Sodium Phosphate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Hydrocortisone Sodium Phosphate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Hydrocortisone Sodium Phosphate suppliers with NDC on PharmaCompass.
Hydrocortisone Sodium Phosphate 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 Hydrocortisone Sodium Phosphate 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 Hydrocortisone Sodium Phosphate GMP manufacturer or Hydrocortisone Sodium Phosphate GMP API supplier for your needs.
A Hydrocortisone Sodium Phosphate CoA (Certificate of Analysis) is a formal document that attests to Hydrocortisone Sodium Phosphate's compliance with Hydrocortisone Sodium Phosphate specifications and serves as a tool for batch-level quality control.
Hydrocortisone Sodium Phosphate CoA mostly includes findings from lab analyses of a specific batch. For each Hydrocortisone Sodium Phosphate 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.
Hydrocortisone Sodium Phosphate may be tested according to a variety of international standards, such as European Pharmacopoeia (Hydrocortisone Sodium Phosphate EP), Hydrocortisone Sodium Phosphate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Hydrocortisone Sodium Phosphate USP).
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