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API SUPPLIERS
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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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...
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API Imports and Exports
Drugs in Development
Lead Product(s) : Aviptadil Acetate,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : Inapplicable
November 06, 2021
Lead Product(s) : Aviptadil Acetate,Inapplicable
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : Inapplicable
November 06, 2021
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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 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aviptadil, including repackagers and relabelers. The FDA regulates Aviptadil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aviptadil 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Aviptadil supplier is an individual or a company that provides Aviptadil active pharmaceutical ingredient (API) or Aviptadil finished formulations upon request. The Aviptadil suppliers may include Aviptadil API manufacturers, exporters, distributors and traders.
click here to find a list of Aviptadil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Aviptadil DMF (Drug Master File) is a document detailing the whole manufacturing process of Aviptadil active pharmaceutical ingredient (API) in detail. Different forms of Aviptadil DMFs exist exist since differing nations have different regulations, such as Aviptadil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Aviptadil DMF submitted to regulatory agencies in the US is known as a USDMF. Aviptadil USDMF includes data on Aviptadil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Aviptadil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Aviptadil suppliers with USDMF on PharmaCompass.
A Aviptadil written confirmation (Aviptadil WC) is an official document issued by a regulatory agency to a Aviptadil manufacturer, verifying that the manufacturing facility of a Aviptadil active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Aviptadil APIs or Aviptadil finished pharmaceutical products to another nation, regulatory agencies frequently require a Aviptadil WC (written confirmation) as part of the regulatory process.
click here to find a list of Aviptadil 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 Aviptadil as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Aviptadil 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Aviptadil NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Aviptadil suppliers with NDC on PharmaCompass.
Aviptadil 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 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 GMP manufacturer or Aviptadil GMP API supplier for your needs.
A Aviptadil CoA (Certificate of Analysis) is a formal document that attests to Aviptadil's compliance with Aviptadil specifications and serves as a tool for batch-level quality control.
Aviptadil CoA mostly includes findings from lab analyses of a specific batch. For each Aviptadil 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Aviptadil EP), Aviptadil JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Aviptadil USP).
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