Synopsis
0
VMF
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
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...
IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
About the Company : Inabata France, established in 1990 and part of the Inabata Group, acquired Pharmasynthèse in 2006. Today, Inabata-Pharmasynthèse offers sourcing, manufacturing, and development ...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
About the Company : Omgene Life Sciences Pvt. Ltd. is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically integ...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios ...
ApiSyn: From early-phase research and process development to reliable cGMP manufacturing worldwide.
About the Company : ApiSyn Healthcare, established in 2017, is a vertically integrated manufacturer of APIs & intermediates serving the global pharmaceutical industry. As part of SynZeal Research, a p...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
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]Boai NKY Pharmaceuticals Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kirsch Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Aeon Procare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Alcedo Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ashland
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CD Formulation
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gloria Interchem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Neelkanth MineChem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nitika Pharmaceutical Specialities
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Welltone Material Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Silverline Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Symrise
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ulanqab Kema New Material
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Disintegrants & Superdisintegrants
Direct Compression
Solubilizers
Granulation
Parenteral
Lubricants & Glidants
Thickeners and Stabilizers
Chewable & Orodispersible Aids
Co-Processed Excipients
Controlled & Modified Release
Emulsifying Agents
Taste Masking
Topical
Surfactant & Foaming Agents
Film Formers & Plasticizers
Coating Systems & Additives
API Stability Enhancers
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
US Patents
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
100
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 Desmopressin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Desmopressin, including repackagers and relabelers. The FDA regulates Desmopressin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Desmopressin 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 Desmopressin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Desmopressin supplier is an individual or a company that provides Desmopressin active pharmaceutical ingredient (API) or Desmopressin finished formulations upon request. The Desmopressin suppliers may include Desmopressin API manufacturers, exporters, distributors and traders.
click here to find a list of Desmopressin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Desmopressin DMF (Drug Master File) is a document detailing the whole manufacturing process of Desmopressin active pharmaceutical ingredient (API) in detail. Different forms of Desmopressin DMFs exist exist since differing nations have different regulations, such as Desmopressin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Desmopressin DMF submitted to regulatory agencies in the US is known as a USDMF. Desmopressin USDMF includes data on Desmopressin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Desmopressin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Desmopressin 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 Desmopressin Drug Master File in Japan (Desmopressin JDMF) empowers Desmopressin 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 Desmopressin JDMF during the approval evaluation for pharmaceutical products. At the time of Desmopressin 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 Desmopressin 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 Desmopressin Drug Master File in Korea (Desmopressin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Desmopressin. The MFDS reviews the Desmopressin KDMF as part of the drug registration process and uses the information provided in the Desmopressin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Desmopressin 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 Desmopressin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Desmopressin suppliers with KDMF on PharmaCompass.
A Desmopressin CEP of the European Pharmacopoeia monograph is often referred to as a Desmopressin Certificate of Suitability (COS). The purpose of a Desmopressin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Desmopressin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Desmopressin to their clients by showing that a Desmopressin CEP has been issued for it. The manufacturer submits a Desmopressin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Desmopressin CEP holder for the record. Additionally, the data presented in the Desmopressin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Desmopressin DMF.
A Desmopressin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Desmopressin 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 Desmopressin suppliers with CEP (COS) on PharmaCompass.
A Desmopressin written confirmation (Desmopressin WC) is an official document issued by a regulatory agency to a Desmopressin manufacturer, verifying that the manufacturing facility of a Desmopressin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Desmopressin APIs or Desmopressin finished pharmaceutical products to another nation, regulatory agencies frequently require a Desmopressin WC (written confirmation) as part of the regulatory process.
click here to find a list of Desmopressin 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 Desmopressin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Desmopressin 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 Desmopressin 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 Desmopressin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Desmopressin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Desmopressin suppliers with NDC on PharmaCompass.
Desmopressin 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 Desmopressin 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 Desmopressin GMP manufacturer or Desmopressin GMP API supplier for your needs.
A Desmopressin CoA (Certificate of Analysis) is a formal document that attests to Desmopressin's compliance with Desmopressin specifications and serves as a tool for batch-level quality control.
Desmopressin CoA mostly includes findings from lab analyses of a specific batch. For each Desmopressin 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.
Desmopressin may be tested according to a variety of international standards, such as European Pharmacopoeia (Desmopressin EP), Desmopressin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Desmopressin USP).
