Synopsis
Synopsis
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CEP/COS
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JDMF
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KDMF
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NDC API
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VMF
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EDQM
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USP
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JP
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Others
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FDA Orange Book
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Canada
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Australia
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South Africa
DRUG PRODUCT COMPOSITIONS
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Data Compilation #PharmaFlow
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Molecular Weight | 345.9 g/mol |
---|---|
Molecular Formula | Ca7Zn+16 |
Hydrogen Bond Donor Count | 0 |
Hydrogen Bond Acceptor Count | 0 |
Rotatable Bond Count | 0 |
Exact Mass | 343.667278 g/mol |
Monoisotopic Mass | 343.667278 g/mol |
Topological Polar Surface Area | 0 Ų |
Heavy Atom Count | 8 |
Formal Charge | 16 |
Complexity | 0 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 8 |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27172
Submission : 2013-05-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23557
Submission : 2010-02-16
Status : Inactive
Type : II
Date of Issue : 2022-07-15
Valid Till : 2025-07-25
Written Confirmation Number : WC-0448
Address of the Firm : Type 'B', Plot No. 5-13, Phase -1, Sector -III, SEZ Indore, Pithampur, District ...
Date of Issue : 2022-06-03
Valid Till : 2024-10-28
Written Confirmation Number : WC-0314A1
Address of the Firm : A 61/62, Malegaon MIDC, Sinnar, Dist. Nashik-422113, Maharashtra, India
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API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
---|
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Regulatory Info :
Registration Country : Italy
Brand Name : Danzen
Dosage Form :
Dosage Strength : 20 Gastrores Cpr 5 Mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name : Serratiopeptidase
Dosage Form : Gastro Resistant Table...
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Packaging :
Regulatory Info :
Dosage : Gastro Resistant Table...
Dosage Strength : 10MG
Brand Name : Serratiopeptidase
Approval Date :
Application Number :
Registration Country : India
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name : Serratiopeptidase
Dosage Form : Gastro Resistant Table...
Dosage Strength : 20MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Packaging :
Regulatory Info :
Dosage : Gastro Resistant Table...
Dosage Strength : 20MG
Brand Name : Serratiopeptidase
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 10MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Aceclofenac; Paracetamol; Serratiopeptidase
Brand Name :
Dosage Form : Tablet
Dosage Strength : 100MG; 325MG; 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Aceclofenac; Paracetamol; Serratiopeptidase
Dosage : Tablet
Dosage Strength : 100MG; 325MG; 10MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Aceclofenac; Paracetamol; Serratiopeptidase
Brand Name :
Dosage Form : Tablet
Dosage Strength : 100MG; 325MG; 15MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Aceclofenac; Paracetamol; Serratiopeptidase
Dosage : Tablet
Dosage Strength : 100MG; 325MG; 15MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name : Nidase
Dosage Form : Tablet
Dosage Strength : 100MG; 15MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 100MG; 15MG
Brand Name : Nidase
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name : SERATOP-10
Dosage Form : Tablet
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 10MG
Brand Name : SERATOP-10
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Aceclofenac; Paracetamol; Serratiopeptidase
Brand Name : Aclommil-PS
Dosage Form : Tablet
Dosage Strength : 100MG; 325MG; 15MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Aceclofenac; Paracetamol; Serratiopeptidase
Dosage : Tablet
Dosage Strength : 100MG; 325MG; 15MG
Brand Name : Aclommil-PS
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 100 MG ; 10 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 100 MG ; 10 MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Diclofenac Potassium; Serratiopeptidase
Brand Name :
Dosage Form : Tablet
Dosage Strength : 50MG; 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Diclofenac Potassium; Serratiopeptidase
Dosage : Tablet
Dosage Strength : 50MG; 10MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Global Sales Information
Dosage Form :
Dosage Strength : 20 Gastrores Cpr 5 Mg
Price Per Pack (Euro) : 9.88
Published in :
Country : Italy
RX/OTC/DISCN : Class C
Market Place
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ABOUT THIS PAGE
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PharmaCompass offers a list of Serratiopeptidase 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 Serratiopeptidase manufacturer or Serratiopeptidase supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Serratiopeptidase manufacturer or Serratiopeptidase supplier.
PharmaCompass also assists you with knowing the Serratiopeptidase API Price utilized in the formulation of products. Serratiopeptidase API Price is not always fixed or binding as the Serratiopeptidase Price is obtained through a variety of data sources. The Serratiopeptidase Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Serrapeptase manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Serrapeptase, including repackagers and relabelers. The FDA regulates Serrapeptase manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Serrapeptase 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 Serrapeptase manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Serrapeptase supplier is an individual or a company that provides Serrapeptase active pharmaceutical ingredient (API) or Serrapeptase finished formulations upon request. The Serrapeptase suppliers may include Serrapeptase API manufacturers, exporters, distributors and traders.
click here to find a list of Serrapeptase suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Serrapeptase DMF (Drug Master File) is a document detailing the whole manufacturing process of Serrapeptase active pharmaceutical ingredient (API) in detail. Different forms of Serrapeptase DMFs exist exist since differing nations have different regulations, such as Serrapeptase USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Serrapeptase DMF submitted to regulatory agencies in the US is known as a USDMF. Serrapeptase USDMF includes data on Serrapeptase's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Serrapeptase USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Serrapeptase suppliers with USDMF on PharmaCompass.
A Serrapeptase written confirmation (Serrapeptase WC) is an official document issued by a regulatory agency to a Serrapeptase manufacturer, verifying that the manufacturing facility of a Serrapeptase active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Serrapeptase APIs or Serrapeptase finished pharmaceutical products to another nation, regulatory agencies frequently require a Serrapeptase WC (written confirmation) as part of the regulatory process.
click here to find a list of Serrapeptase suppliers with Written Confirmation (WC) on PharmaCompass.
Serrapeptase 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 Serrapeptase 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 Serrapeptase GMP manufacturer or Serrapeptase GMP API supplier for your needs.
A Serrapeptase CoA (Certificate of Analysis) is a formal document that attests to Serrapeptase's compliance with Serrapeptase specifications and serves as a tool for batch-level quality control.
Serrapeptase CoA mostly includes findings from lab analyses of a specific batch. For each Serrapeptase 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.
Serrapeptase may be tested according to a variety of international standards, such as European Pharmacopoeia (Serrapeptase EP), Serrapeptase JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Serrapeptase USP).