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VMF
DRUG PRODUCT COMPOSITIONS0
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Axplora- The partner of choice for complex APIs.
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Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
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Coral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
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Atman Pharmaceuticals: A One Stop Solution Provider to All Your API Needs.
TAPI offers customized CDMO Solutions for API development and manufacturing services.
ASMF
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USDMF
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Drugs in Development
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Regulatory Info :
Registration Country : Sweden
beclomethasone dipropionate, anhydrous
Brand Name : Beclomet Easyhaler
Dosage Form : INHALATION
Dosage Strength : 200 MICROGRAMS / DOSE
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Norway
Brand Name : Beclomet Easy Tails
Dosage Form : Inhalasjonspulver
Dosage Strength : 200 mcg/dose
Packaging : Inhalator
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Beclomet Easy Tails
Dosage Form : Inhalasjonspulver
Dosage Strength : 200 mcg/dose
Packaging : Inhalator with protection holster
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
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Regulatory Info : Generic
Registration Country : Canada
Brand Name :
Dosage Form : NASAL SPRAY
Dosage Strength : 50MCG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Canada
Regulatory Info : Generic
Registration Country : Canada
Brand Name :
Dosage Form : NASAL SPRAY
Dosage Strength : 100MCG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Canada
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Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Ventnaze Aqueous 200D
Dosage Form : SPO
Dosage Strength : 100mcg/dose
Packaging : 100X1mcg/dose
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
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Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Clotrimazole; Beclomethasone Dipropionate; Gentamicin Sulfate
Brand Name :
Dosage Form : Cream
Dosage Strength : 1%; 0.025%; 0.1%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - SPRAY, METERED;NASAL - EQ 0.042MG DI...DOSAGE - SPRAY, METERED;NASAL - EQ 0.042MG DIPROP/SPRAY
USFDA APPLICATION NUMBER - 19389
DOSAGE - AEROSOL, METERED;NASAL - 0.04MG/ACTU...DOSAGE - AEROSOL, METERED;NASAL - 0.04MG/ACTUATION
USFDA APPLICATION NUMBER - 202813
DOSAGE - AEROSOL, METERED;NASAL - 0.08MG/ACTU...DOSAGE - AEROSOL, METERED;NASAL - 0.08MG/ACTUATION
USFDA APPLICATION NUMBER - 202813
DOSAGE - AEROSOL, METERED;INHALATION - 0.04MG...DOSAGE - AEROSOL, METERED;INHALATION - 0.04MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20911
DOSAGE - AEROSOL, METERED;INHALATION - 0.08MG...DOSAGE - AEROSOL, METERED;INHALATION - 0.08MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20911
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REF. STANDARDS & IMPURITIES
USP
ABOUT THIS PAGE
A Beclomethasone Dipropionate Monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Beclomethasone Dipropionate Monohydrate, including repackagers and relabelers. The FDA regulates Beclomethasone Dipropionate Monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Beclomethasone Dipropionate Monohydrate 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 Beclomethasone Dipropionate Monohydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Beclomethasone Dipropionate Monohydrate supplier is an individual or a company that provides Beclomethasone Dipropionate Monohydrate active pharmaceutical ingredient (API) or Beclomethasone Dipropionate Monohydrate finished formulations upon request. The Beclomethasone Dipropionate Monohydrate suppliers may include Beclomethasone Dipropionate Monohydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Beclomethasone Dipropionate Monohydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Beclomethasone Dipropionate Monohydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Beclomethasone Dipropionate Monohydrate active pharmaceutical ingredient (API) in detail. Different forms of Beclomethasone Dipropionate Monohydrate DMFs exist exist since differing nations have different regulations, such as Beclomethasone Dipropionate Monohydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Beclomethasone Dipropionate Monohydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Beclomethasone Dipropionate Monohydrate USDMF includes data on Beclomethasone Dipropionate Monohydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Beclomethasone Dipropionate Monohydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Beclomethasone Dipropionate Monohydrate 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 Beclomethasone Dipropionate Monohydrate Drug Master File in Japan (Beclomethasone Dipropionate Monohydrate JDMF) empowers Beclomethasone Dipropionate Monohydrate 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 Beclomethasone Dipropionate Monohydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Beclomethasone Dipropionate Monohydrate 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 Beclomethasone Dipropionate Monohydrate 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 Beclomethasone Dipropionate Monohydrate Drug Master File in Korea (Beclomethasone Dipropionate Monohydrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Beclomethasone Dipropionate Monohydrate. The MFDS reviews the Beclomethasone Dipropionate Monohydrate KDMF as part of the drug registration process and uses the information provided in the Beclomethasone Dipropionate Monohydrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Beclomethasone Dipropionate Monohydrate 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 Beclomethasone Dipropionate Monohydrate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Beclomethasone Dipropionate Monohydrate suppliers with KDMF on PharmaCompass.
A Beclomethasone Dipropionate Monohydrate CEP of the European Pharmacopoeia monograph is often referred to as a Beclomethasone Dipropionate Monohydrate Certificate of Suitability (COS). The purpose of a Beclomethasone Dipropionate Monohydrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Beclomethasone Dipropionate Monohydrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Beclomethasone Dipropionate Monohydrate to their clients by showing that a Beclomethasone Dipropionate Monohydrate CEP has been issued for it. The manufacturer submits a Beclomethasone Dipropionate Monohydrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Beclomethasone Dipropionate Monohydrate CEP holder for the record. Additionally, the data presented in the Beclomethasone Dipropionate Monohydrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Beclomethasone Dipropionate Monohydrate DMF.
A Beclomethasone Dipropionate Monohydrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Beclomethasone Dipropionate Monohydrate 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 Beclomethasone Dipropionate Monohydrate suppliers with CEP (COS) on PharmaCompass.
A Beclomethasone Dipropionate Monohydrate written confirmation (Beclomethasone Dipropionate Monohydrate WC) is an official document issued by a regulatory agency to a Beclomethasone Dipropionate Monohydrate manufacturer, verifying that the manufacturing facility of a Beclomethasone Dipropionate Monohydrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Beclomethasone Dipropionate Monohydrate APIs or Beclomethasone Dipropionate Monohydrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Beclomethasone Dipropionate Monohydrate WC (written confirmation) as part of the regulatory process.
click here to find a list of Beclomethasone Dipropionate Monohydrate 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 Beclomethasone Dipropionate Monohydrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Beclomethasone Dipropionate Monohydrate 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 Beclomethasone Dipropionate Monohydrate 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 Beclomethasone Dipropionate Monohydrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Beclomethasone Dipropionate Monohydrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Beclomethasone Dipropionate Monohydrate suppliers with NDC on PharmaCompass.
Beclomethasone Dipropionate Monohydrate 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 Beclomethasone Dipropionate Monohydrate 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 Beclomethasone Dipropionate Monohydrate GMP manufacturer or Beclomethasone Dipropionate Monohydrate GMP API supplier for your needs.
A Beclomethasone Dipropionate Monohydrate CoA (Certificate of Analysis) is a formal document that attests to Beclomethasone Dipropionate Monohydrate's compliance with Beclomethasone Dipropionate Monohydrate specifications and serves as a tool for batch-level quality control.
Beclomethasone Dipropionate Monohydrate CoA mostly includes findings from lab analyses of a specific batch. For each Beclomethasone Dipropionate Monohydrate 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.
Beclomethasone Dipropionate Monohydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Beclomethasone Dipropionate Monohydrate EP), Beclomethasone Dipropionate Monohydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Beclomethasone Dipropionate Monohydrate USP).
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