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FDF Dossiers
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Europe
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API SUPPLIERS
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USDMF
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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
Lead Product(s) : Aviptadil Acetate
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Biophore seeks DCGI Emergency Use Approval of Aviptadil for Covid-19
Details : Aviptadil is a synthetic form of vasoactive intestinal peptide (VIP) that, when administered, results in rapid clinical recovery in patients with severe SARS-COV-2 infection. Biophore has successfully developed aviptadil and is backward integrated with i...
Product Name : Undisclosed
Product Type : Peptide
Upfront Cash : Not Applicable
June 11, 2021
Lead Product(s) : Aviptadil Acetate
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Biophore Applies For DCGI Approval for Emergency Use of Aviptadil to Treat COVID-19
Details : Biophore has developed Aviptadil and is backward integrated with in-house API. The company has also informed that it will be commencing commercial production immediately after the approval is received.
Product Name : Undisclosed
Product Type : Peptide
Upfront Cash : Not Applicable
June 11, 2021
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
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PharmaCompass offers a list of Aviptadil 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 Aviptadil Acetate manufacturer or Aviptadil Acetate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Aviptadil Acetate manufacturer or Aviptadil Acetate supplier.
PharmaCompass also assists you with knowing the Aviptadil Acetate API Price utilized in the formulation of products. Aviptadil Acetate API Price is not always fixed or binding as the Aviptadil Acetate Price is obtained through a variety of data sources. The Aviptadil Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Aviptadil Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aviptadil Acetate, including repackagers and relabelers. The FDA regulates Aviptadil Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aviptadil Acetate 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 Aviptadil Acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Aviptadil Acetate supplier is an individual or a company that provides Aviptadil Acetate active pharmaceutical ingredient (API) or Aviptadil Acetate finished formulations upon request. The Aviptadil Acetate suppliers may include Aviptadil Acetate API manufacturers, exporters, distributors and traders.
click here to find a list of Aviptadil Acetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Aviptadil Acetate DMF (Drug Master File) is a document detailing the whole manufacturing process of Aviptadil Acetate active pharmaceutical ingredient (API) in detail. Different forms of Aviptadil Acetate DMFs exist exist since differing nations have different regulations, such as Aviptadil Acetate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Aviptadil Acetate DMF submitted to regulatory agencies in the US is known as a USDMF. Aviptadil Acetate USDMF includes data on Aviptadil Acetate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Aviptadil Acetate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Aviptadil Acetate suppliers with USDMF 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 Aviptadil Acetate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Aviptadil Acetate 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 Aviptadil Acetate 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 Aviptadil Acetate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Aviptadil Acetate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Aviptadil Acetate suppliers with NDC on PharmaCompass.
Aviptadil Acetate 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 Aviptadil Acetate 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 Aviptadil Acetate GMP manufacturer or Aviptadil Acetate GMP API supplier for your needs.
A Aviptadil Acetate CoA (Certificate of Analysis) is a formal document that attests to Aviptadil Acetate's compliance with Aviptadil Acetate specifications and serves as a tool for batch-level quality control.
Aviptadil Acetate CoA mostly includes findings from lab analyses of a specific batch. For each Aviptadil Acetate 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.
Aviptadil Acetate may be tested according to a variety of international standards, such as European Pharmacopoeia (Aviptadil Acetate EP), Aviptadil Acetate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Aviptadil Acetate USP).
