Synopsis
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VMF
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Aspen API. More than just an API™
CEP/COS 
NDC
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
ASMF
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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USDMF
Aspen API. More than just an API™
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10175
Submission : 1993-03-30
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-06
Pay. Date : 2012-12-03
DMF Number : 16947
Submission : 2003-11-07
Status :
Type : II
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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 - SOLUTION;NASAL - 0.01%
USFDA APPLICATION NUMBER - 17922
DOSAGE - SPRAY, METERED;NASAL - 0.01MG/SPRAY ...DOSAGE - SPRAY, METERED;NASAL - 0.01MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 17922
DOSAGE - INJECTABLE;INJECTION - 0.004MG/ML
USFDA APPLICATION NUMBER - 18938
DOSAGE - TABLET;ORAL - 0.1MG
USFDA APPLICATION NUMBER - 19955
DOSAGE - TABLET;ORAL - 0.2MG
USFDA APPLICATION NUMBER - 19955
DOSAGE - SPRAY, METERED;NASAL - 0.00083MG/SPR...DOSAGE - SPRAY, METERED;NASAL - 0.00083MG/SPRAY
USFDA APPLICATION NUMBER - 201656
DOSAGE - SPRAY, METERED;NASAL - 0.00166MG/SPR...DOSAGE - SPRAY, METERED;NASAL - 0.00166MG/SPRAY
USFDA APPLICATION NUMBER - 201656
DOSAGE - SPRAY, METERED;NASAL - 0.15MG/SPRAY
USFDA APPLICATION NUMBER - 20355
DOSAGE - SPRAY, METERED;NASAL - 0.01MG/SPRAY
USFDA APPLICATION NUMBER - 21333
DOSAGE - TABLET;SUBLINGUAL - 0.0277MG
USFDA APPLICATION NUMBER - 22517
DOSAGE - TABLET;SUBLINGUAL - 0.0553MG
USFDA APPLICATION NUMBER - 22517
Related Excipient Companies
SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
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Disintegrants & Superdisintegrants
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Granulation
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Chewable & Orodispersible Aids
Emulsifying Agents
Topical
Taste Masking
Surfactant & Foaming Agents
Coating Systems & Additives
Film Formers & Plasticizers
API Stability Enhancers
Digital Content
NEWS #PharmaBuzz
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US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
37
PharmaCompass offers a list of Desmopressin Acetate 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 Desmopressin Acetate manufacturer or Desmopressin Acetate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Desmopressin Acetate manufacturer or Desmopressin Acetate supplier.
PharmaCompass also assists you with knowing the Desmopressin Acetate API Price utilized in the formulation of products. Desmopressin Acetate API Price is not always fixed or binding as the Desmopressin Acetate Price is obtained through a variety of data sources. The Desmopressin Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Desmogalen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Desmogalen, including repackagers and relabelers. The FDA regulates Desmogalen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Desmogalen 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 Desmogalen manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Desmogalen supplier is an individual or a company that provides Desmogalen active pharmaceutical ingredient (API) or Desmogalen finished formulations upon request. The Desmogalen suppliers may include Desmogalen API manufacturers, exporters, distributors and traders.
click here to find a list of Desmogalen suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Desmogalen DMF (Drug Master File) is a document detailing the whole manufacturing process of Desmogalen active pharmaceutical ingredient (API) in detail. Different forms of Desmogalen DMFs exist exist since differing nations have different regulations, such as Desmogalen USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Desmogalen DMF submitted to regulatory agencies in the US is known as a USDMF. Desmogalen USDMF includes data on Desmogalen's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Desmogalen USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Desmogalen 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 Desmogalen Drug Master File in Japan (Desmogalen JDMF) empowers Desmogalen 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 Desmogalen JDMF during the approval evaluation for pharmaceutical products. At the time of Desmogalen 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 Desmogalen 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 Desmogalen Drug Master File in Korea (Desmogalen KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Desmogalen. The MFDS reviews the Desmogalen KDMF as part of the drug registration process and uses the information provided in the Desmogalen KDMF to evaluate the safety and efficacy of the drug.
After submitting a Desmogalen 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 Desmogalen API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Desmogalen suppliers with KDMF on PharmaCompass.
A Desmogalen CEP of the European Pharmacopoeia monograph is often referred to as a Desmogalen Certificate of Suitability (COS). The purpose of a Desmogalen CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Desmogalen EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Desmogalen to their clients by showing that a Desmogalen CEP has been issued for it. The manufacturer submits a Desmogalen CEP (COS) as part of the market authorization procedure, and it takes on the role of a Desmogalen CEP holder for the record. Additionally, the data presented in the Desmogalen CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Desmogalen DMF.
A Desmogalen CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Desmogalen 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 Desmogalen suppliers with CEP (COS) on PharmaCompass.
A Desmogalen written confirmation (Desmogalen WC) is an official document issued by a regulatory agency to a Desmogalen manufacturer, verifying that the manufacturing facility of a Desmogalen active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Desmogalen APIs or Desmogalen finished pharmaceutical products to another nation, regulatory agencies frequently require a Desmogalen WC (written confirmation) as part of the regulatory process.
click here to find a list of Desmogalen 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 Desmogalen as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Desmogalen 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 Desmogalen 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 Desmogalen and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Desmogalen NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Desmogalen suppliers with NDC on PharmaCompass.
Desmogalen 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 Desmogalen 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 Desmogalen GMP manufacturer or Desmogalen GMP API supplier for your needs.
A Desmogalen CoA (Certificate of Analysis) is a formal document that attests to Desmogalen's compliance with Desmogalen specifications and serves as a tool for batch-level quality control.
Desmogalen CoA mostly includes findings from lab analyses of a specific batch. For each Desmogalen 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.
Desmogalen may be tested according to a variety of international standards, such as European Pharmacopoeia (Desmogalen EP), Desmogalen JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Desmogalen USP).
