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API SUPPLIERS
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USDMF
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
GDUFA
DMF Review : Complete
Rev. Date : 2017-11-07
Pay. Date : 2017-04-28
DMF Number : 31546
Submission : 2017-05-12
Status :
Type : II
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Rochem International Inc
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Dosage Form : Cream / Lotion / Ointment
Grade : Topical, Oral
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Dosage Form : Tablet
Grade : Oral
Application : Taste Masking
Excipient Details : Mannitol is used as a filler, bulking agent and taste masking agent in ODT formulations such as tablets.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Dosage Form : Suspension
Grade : Oral
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Dosage Form : Suspension
Grade : Oral
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ABOUT THIS PAGE
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PharmaCompass offers a list of Valganciclovir 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 Valganciclovir Hydrochloride manufacturer or Valganciclovir Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Valganciclovir Hydrochloride manufacturer or Valganciclovir Hydrochloride supplier.
PharmaCompass also assists you with knowing the Valganciclovir Hydrochloride API Price utilized in the formulation of products. Valganciclovir Hydrochloride API Price is not always fixed or binding as the Valganciclovir Hydrochloride Price is obtained through a variety of data sources. The Valganciclovir Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Valganciclovir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Valganciclovir, including repackagers and relabelers. The FDA regulates Valganciclovir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Valganciclovir 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 Valganciclovir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Valganciclovir supplier is an individual or a company that provides Valganciclovir active pharmaceutical ingredient (API) or Valganciclovir finished formulations upon request. The Valganciclovir suppliers may include Valganciclovir API manufacturers, exporters, distributors and traders.
click here to find a list of Valganciclovir suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Valganciclovir DMF (Drug Master File) is a document detailing the whole manufacturing process of Valganciclovir active pharmaceutical ingredient (API) in detail. Different forms of Valganciclovir DMFs exist exist since differing nations have different regulations, such as Valganciclovir USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Valganciclovir DMF submitted to regulatory agencies in the US is known as a USDMF. Valganciclovir USDMF includes data on Valganciclovir's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Valganciclovir USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Valganciclovir suppliers with USDMF on PharmaCompass.
A Valganciclovir CEP of the European Pharmacopoeia monograph is often referred to as a Valganciclovir Certificate of Suitability (COS). The purpose of a Valganciclovir CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Valganciclovir EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Valganciclovir to their clients by showing that a Valganciclovir CEP has been issued for it. The manufacturer submits a Valganciclovir CEP (COS) as part of the market authorization procedure, and it takes on the role of a Valganciclovir CEP holder for the record. Additionally, the data presented in the Valganciclovir CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Valganciclovir DMF.
A Valganciclovir CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Valganciclovir 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 Valganciclovir suppliers with CEP (COS) on PharmaCompass.
A Valganciclovir written confirmation (Valganciclovir WC) is an official document issued by a regulatory agency to a Valganciclovir manufacturer, verifying that the manufacturing facility of a Valganciclovir active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Valganciclovir APIs or Valganciclovir finished pharmaceutical products to another nation, regulatory agencies frequently require a Valganciclovir WC (written confirmation) as part of the regulatory process.
click here to find a list of Valganciclovir 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 Valganciclovir as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Valganciclovir 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 Valganciclovir 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 Valganciclovir and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Valganciclovir NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Valganciclovir suppliers with NDC on PharmaCompass.
Valganciclovir 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 Valganciclovir 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 Valganciclovir GMP manufacturer or Valganciclovir GMP API supplier for your needs.
A Valganciclovir CoA (Certificate of Analysis) is a formal document that attests to Valganciclovir's compliance with Valganciclovir specifications and serves as a tool for batch-level quality control.
Valganciclovir CoA mostly includes findings from lab analyses of a specific batch. For each Valganciclovir 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.
Valganciclovir may be tested according to a variety of international standards, such as European Pharmacopoeia (Valganciclovir EP), Valganciclovir JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Valganciclovir USP).
