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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
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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
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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...
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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
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ABOUT THIS PAGE
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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 Nocutil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nocutil, including repackagers and relabelers. The FDA regulates Nocutil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nocutil 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 Nocutil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nocutil supplier is an individual or a company that provides Nocutil active pharmaceutical ingredient (API) or Nocutil finished formulations upon request. The Nocutil suppliers may include Nocutil API manufacturers, exporters, distributors and traders.
click here to find a list of Nocutil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nocutil DMF (Drug Master File) is a document detailing the whole manufacturing process of Nocutil active pharmaceutical ingredient (API) in detail. Different forms of Nocutil DMFs exist exist since differing nations have different regulations, such as Nocutil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nocutil DMF submitted to regulatory agencies in the US is known as a USDMF. Nocutil USDMF includes data on Nocutil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nocutil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nocutil 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 Nocutil Drug Master File in Japan (Nocutil JDMF) empowers Nocutil 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 Nocutil JDMF during the approval evaluation for pharmaceutical products. At the time of Nocutil 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 Nocutil 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 Nocutil Drug Master File in Korea (Nocutil KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Nocutil. The MFDS reviews the Nocutil KDMF as part of the drug registration process and uses the information provided in the Nocutil KDMF to evaluate the safety and efficacy of the drug.
After submitting a Nocutil 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 Nocutil API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Nocutil suppliers with KDMF on PharmaCompass.
A Nocutil CEP of the European Pharmacopoeia monograph is often referred to as a Nocutil Certificate of Suitability (COS). The purpose of a Nocutil CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Nocutil EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Nocutil to their clients by showing that a Nocutil CEP has been issued for it. The manufacturer submits a Nocutil CEP (COS) as part of the market authorization procedure, and it takes on the role of a Nocutil CEP holder for the record. Additionally, the data presented in the Nocutil CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Nocutil DMF.
A Nocutil CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Nocutil 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 Nocutil suppliers with CEP (COS) on PharmaCompass.
A Nocutil written confirmation (Nocutil WC) is an official document issued by a regulatory agency to a Nocutil manufacturer, verifying that the manufacturing facility of a Nocutil active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Nocutil APIs or Nocutil finished pharmaceutical products to another nation, regulatory agencies frequently require a Nocutil WC (written confirmation) as part of the regulatory process.
click here to find a list of Nocutil 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 Nocutil as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Nocutil 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 Nocutil 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 Nocutil and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nocutil NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Nocutil suppliers with NDC on PharmaCompass.
Nocutil 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 Nocutil 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 Nocutil GMP manufacturer or Nocutil GMP API supplier for your needs.
A Nocutil CoA (Certificate of Analysis) is a formal document that attests to Nocutil's compliance with Nocutil specifications and serves as a tool for batch-level quality control.
Nocutil CoA mostly includes findings from lab analyses of a specific batch. For each Nocutil 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.
Nocutil may be tested according to a variety of international standards, such as European Pharmacopoeia (Nocutil EP), Nocutil JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nocutil USP).
