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API SUPPLIERS
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
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Synnat Pharma is one of the leading active pharmaceutical ingredients and intermediates manufacturers.
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
NDC 
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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USDMF
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
GDUFA
DMF Review : Complete
Rev. Date : 2018-09-17
Pay. Date : 2018-09-12
DMF Number : 28295
Submission : 2014-08-12
Status :
Type : II
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25758
Submission : 2012-02-03
Status :
Type : II
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Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
About the Company : Since its inception in 2003, Seqens has evolved into a global leader in pharmaceutical solutions and specialty ingredients. With a strong focus on customer support, Seqens assists ...
Synnat Pharma is one of the leading active pharmaceutical ingredients and intermediates manufacturers.
About the Company : Synnat Pharma is a fast-growing pharmaceutical company dedicated to the identification, development, production and distribution of potent phytochemicals and botanical extracts. AP...
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
About the Company : Transform your biologic formulations with Pfanstiehl, the industry leader in High-Purity Low Endotoxin Low Metals Parenteral grade excipient manufacturing. Our expertise spans isol...
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DOSAGE - SOLUTION;TOPICAL - 0.5%
USFDA APPLICATION NUMBER - 19795
DOSAGE - GEL;TOPICAL - 0.5%
USFDA APPLICATION NUMBER - 20529
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ABOUT THIS PAGE
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PharmaCompass offers a list of Podophyllotoxin 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 Podophyllotoxin manufacturer or Podophyllotoxin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Podophyllotoxin manufacturer or Podophyllotoxin supplier.
PharmaCompass also assists you with knowing the Podophyllotoxin API Price utilized in the formulation of products. Podophyllotoxin API Price is not always fixed or binding as the Podophyllotoxin Price is obtained through a variety of data sources. The Podophyllotoxin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Podophyllotoxin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Podophyllotoxin, including repackagers and relabelers. The FDA regulates Podophyllotoxin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Podophyllotoxin 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 Podophyllotoxin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Podophyllotoxin supplier is an individual or a company that provides Podophyllotoxin active pharmaceutical ingredient (API) or Podophyllotoxin finished formulations upon request. The Podophyllotoxin suppliers may include Podophyllotoxin API manufacturers, exporters, distributors and traders.
click here to find a list of Podophyllotoxin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Podophyllotoxin DMF (Drug Master File) is a document detailing the whole manufacturing process of Podophyllotoxin active pharmaceutical ingredient (API) in detail. Different forms of Podophyllotoxin DMFs exist exist since differing nations have different regulations, such as Podophyllotoxin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Podophyllotoxin DMF submitted to regulatory agencies in the US is known as a USDMF. Podophyllotoxin USDMF includes data on Podophyllotoxin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Podophyllotoxin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Podophyllotoxin suppliers with USDMF on PharmaCompass.
A Podophyllotoxin written confirmation (Podophyllotoxin WC) is an official document issued by a regulatory agency to a Podophyllotoxin manufacturer, verifying that the manufacturing facility of a Podophyllotoxin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Podophyllotoxin APIs or Podophyllotoxin finished pharmaceutical products to another nation, regulatory agencies frequently require a Podophyllotoxin WC (written confirmation) as part of the regulatory process.
click here to find a list of Podophyllotoxin 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 Podophyllotoxin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Podophyllotoxin 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 Podophyllotoxin 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 Podophyllotoxin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Podophyllotoxin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Podophyllotoxin suppliers with NDC on PharmaCompass.
Podophyllotoxin 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 Podophyllotoxin 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 Podophyllotoxin GMP manufacturer or Podophyllotoxin GMP API supplier for your needs.
A Podophyllotoxin CoA (Certificate of Analysis) is a formal document that attests to Podophyllotoxin's compliance with Podophyllotoxin specifications and serves as a tool for batch-level quality control.
Podophyllotoxin CoA mostly includes findings from lab analyses of a specific batch. For each Podophyllotoxin 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.
Podophyllotoxin may be tested according to a variety of international standards, such as European Pharmacopoeia (Podophyllotoxin EP), Podophyllotoxin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Podophyllotoxin USP).
