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API SUPPLIERS
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Jai Radhe Sales is your partner for all your sourcing needs.
Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
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USDMF
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Rochem International Inc
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ABOUT THIS PAGE
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PharmaCompass offers a list of Cyproheptadine Hydrochloride 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 Cyproheptadine Hydrochloride manufacturer or Cyproheptadine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cyproheptadine Hydrochloride manufacturer or Cyproheptadine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Cyproheptadine Hydrochloride API Price utilized in the formulation of products. Cyproheptadine Hydrochloride API Price is not always fixed or binding as the Cyproheptadine Hydrochloride Price is obtained through a variety of data sources. The Cyproheptadine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Viternum manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Viternum, including repackagers and relabelers. The FDA regulates Viternum manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Viternum 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 Viternum manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Viternum supplier is an individual or a company that provides Viternum active pharmaceutical ingredient (API) or Viternum finished formulations upon request. The Viternum suppliers may include Viternum API manufacturers, exporters, distributors and traders.
click here to find a list of Viternum suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Viternum DMF (Drug Master File) is a document detailing the whole manufacturing process of Viternum active pharmaceutical ingredient (API) in detail. Different forms of Viternum DMFs exist exist since differing nations have different regulations, such as Viternum USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Viternum DMF submitted to regulatory agencies in the US is known as a USDMF. Viternum USDMF includes data on Viternum's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Viternum USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Viternum 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 Viternum Drug Master File in Japan (Viternum JDMF) empowers Viternum 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 Viternum JDMF during the approval evaluation for pharmaceutical products. At the time of Viternum 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 Viternum suppliers with JDMF on PharmaCompass.
A Viternum CEP of the European Pharmacopoeia monograph is often referred to as a Viternum Certificate of Suitability (COS). The purpose of a Viternum CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Viternum EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Viternum to their clients by showing that a Viternum CEP has been issued for it. The manufacturer submits a Viternum CEP (COS) as part of the market authorization procedure, and it takes on the role of a Viternum CEP holder for the record. Additionally, the data presented in the Viternum CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Viternum DMF.
A Viternum CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Viternum 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 Viternum suppliers with CEP (COS) on PharmaCompass.
A Viternum written confirmation (Viternum WC) is an official document issued by a regulatory agency to a Viternum manufacturer, verifying that the manufacturing facility of a Viternum active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Viternum APIs or Viternum finished pharmaceutical products to another nation, regulatory agencies frequently require a Viternum WC (written confirmation) as part of the regulatory process.
click here to find a list of Viternum 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 Viternum as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Viternum 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 Viternum 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 Viternum and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Viternum NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Viternum suppliers with NDC on PharmaCompass.
Viternum 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 Viternum 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 Viternum GMP manufacturer or Viternum GMP API supplier for your needs.
A Viternum CoA (Certificate of Analysis) is a formal document that attests to Viternum's compliance with Viternum specifications and serves as a tool for batch-level quality control.
Viternum CoA mostly includes findings from lab analyses of a specific batch. For each Viternum 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.
Viternum may be tested according to a variety of international standards, such as European Pharmacopoeia (Viternum EP), Viternum JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Viternum USP).
