X
API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
Other Certificates
Other Suppliers
0
USA (Orange Book)
Europe
Canada
Australia
South Africa
0
Uploaded Dossiers
U.S. Medicaid
Annual Reports
0
0
66
PharmaCompass offers a list of Calcitonin 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 Calcitonin manufacturer or Calcitonin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Calcitonin manufacturer or Calcitonin supplier.
PharmaCompass also assists you with knowing the Calcitonin API Price utilized in the formulation of products. Calcitonin API Price is not always fixed or binding as the Calcitonin Price is obtained through a variety of data sources. The Calcitonin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Elcatonin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Elcatonin, including repackagers and relabelers. The FDA regulates Elcatonin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Elcatonin 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 Elcatonin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Elcatonin supplier is an individual or a company that provides Elcatonin active pharmaceutical ingredient (API) or Elcatonin finished formulations upon request. The Elcatonin suppliers may include Elcatonin API manufacturers, exporters, distributors and traders.
click here to find a list of Elcatonin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Elcatonin DMF (Drug Master File) is a document detailing the whole manufacturing process of Elcatonin active pharmaceutical ingredient (API) in detail. Different forms of Elcatonin DMFs exist exist since differing nations have different regulations, such as Elcatonin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Elcatonin DMF submitted to regulatory agencies in the US is known as a USDMF. Elcatonin USDMF includes data on Elcatonin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Elcatonin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Elcatonin suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Elcatonin Drug Master File in Japan (Elcatonin JDMF) empowers Elcatonin API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Elcatonin JDMF during the approval evaluation for pharmaceutical products. At the time of Elcatonin JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Elcatonin suppliers with JDMF on PharmaCompass.
A Elcatonin CEP of the European Pharmacopoeia monograph is often referred to as a Elcatonin Certificate of Suitability (COS). The purpose of a Elcatonin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Elcatonin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Elcatonin to their clients by showing that a Elcatonin CEP has been issued for it. The manufacturer submits a Elcatonin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Elcatonin CEP holder for the record. Additionally, the data presented in the Elcatonin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Elcatonin DMF.
A Elcatonin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Elcatonin CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Elcatonin suppliers with CEP (COS) on PharmaCompass.
A Elcatonin written confirmation (Elcatonin WC) is an official document issued by a regulatory agency to a Elcatonin manufacturer, verifying that the manufacturing facility of a Elcatonin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Elcatonin APIs or Elcatonin finished pharmaceutical products to another nation, regulatory agencies frequently require a Elcatonin WC (written confirmation) as part of the regulatory process.
click here to find a list of Elcatonin 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 Elcatonin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Elcatonin 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 Elcatonin 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 Elcatonin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Elcatonin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Elcatonin suppliers with NDC on PharmaCompass.
Elcatonin 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 Elcatonin 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 Elcatonin GMP manufacturer or Elcatonin GMP API supplier for your needs.
A Elcatonin CoA (Certificate of Analysis) is a formal document that attests to Elcatonin's compliance with Elcatonin specifications and serves as a tool for batch-level quality control.
Elcatonin CoA mostly includes findings from lab analyses of a specific batch. For each Elcatonin 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.
Elcatonin may be tested according to a variety of international standards, such as European Pharmacopoeia (Elcatonin EP), Elcatonin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Elcatonin USP).
Market Place
