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USDMF
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : Complete
Rev. Date : 2017-09-29
Pay. Date : 2017-08-24
DMF Number : 28532
Submission : 2014-08-01
Status :
Type : II
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API Imports and Exports
Drugs in Development
Lead Product(s) : Arginine Vasopressin
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Dr. Reddy's Laboratories Announces the Launch of Its Authorized Generic Version of VASOSTRICT® (v...
Details : The launch of authorized generic version of Par Pharmaceutical’s VASOSTRICT® (vasopressin injection, USP) Vials in the U.S. Market was approved by the U.S. Food and Drug Administration (USFDA).
Product Name : Vasopressin-Generic
Product Type : Peptide
Upfront Cash : Inapplicable
September 02, 2022
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PharmaCompass offers a list of Arginine Vasopressin 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 Arginine Vasopressin manufacturer or Arginine Vasopressin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Arginine Vasopressin manufacturer or Arginine Vasopressin supplier.
PharmaCompass also assists you with knowing the Arginine Vasopressin API Price utilized in the formulation of products. Arginine Vasopressin API Price is not always fixed or binding as the Arginine Vasopressin Price is obtained through a variety of data sources. The Arginine Vasopressin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Vasopressin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vasopressin, including repackagers and relabelers. The FDA regulates Vasopressin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vasopressin 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 Vasopressin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Vasopressin supplier is an individual or a company that provides Vasopressin active pharmaceutical ingredient (API) or Vasopressin finished formulations upon request. The Vasopressin suppliers may include Vasopressin API manufacturers, exporters, distributors and traders.
click here to find a list of Vasopressin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Vasopressin DMF (Drug Master File) is a document detailing the whole manufacturing process of Vasopressin active pharmaceutical ingredient (API) in detail. Different forms of Vasopressin DMFs exist exist since differing nations have different regulations, such as Vasopressin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Vasopressin DMF submitted to regulatory agencies in the US is known as a USDMF. Vasopressin USDMF includes data on Vasopressin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Vasopressin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Vasopressin suppliers with USDMF on PharmaCompass.
A Vasopressin written confirmation (Vasopressin WC) is an official document issued by a regulatory agency to a Vasopressin manufacturer, verifying that the manufacturing facility of a Vasopressin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Vasopressin APIs or Vasopressin finished pharmaceutical products to another nation, regulatory agencies frequently require a Vasopressin WC (written confirmation) as part of the regulatory process.
click here to find a list of Vasopressin 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 Vasopressin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Vasopressin 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 Vasopressin 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 Vasopressin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Vasopressin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Vasopressin suppliers with NDC on PharmaCompass.
Vasopressin 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 Vasopressin 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 Vasopressin GMP manufacturer or Vasopressin GMP API supplier for your needs.
A Vasopressin CoA (Certificate of Analysis) is a formal document that attests to Vasopressin's compliance with Vasopressin specifications and serves as a tool for batch-level quality control.
Vasopressin CoA mostly includes findings from lab analyses of a specific batch. For each Vasopressin 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.
Vasopressin may be tested according to a variety of international standards, such as European Pharmacopoeia (Vasopressin EP), Vasopressin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Vasopressin USP).
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