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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 Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Valganciclovir Hydrochloride, including repackagers and relabelers. The FDA regulates Valganciclovir Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Valganciclovir Hydrochloride 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 Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Valganciclovir Hydrochloride supplier is an individual or a company that provides Valganciclovir Hydrochloride active pharmaceutical ingredient (API) or Valganciclovir Hydrochloride finished formulations upon request. The Valganciclovir Hydrochloride suppliers may include Valganciclovir Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Valganciclovir Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Valganciclovir Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Valganciclovir Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Valganciclovir Hydrochloride DMFs exist exist since differing nations have different regulations, such as Valganciclovir Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Valganciclovir Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Valganciclovir Hydrochloride USDMF includes data on Valganciclovir Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Valganciclovir Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Valganciclovir Hydrochloride suppliers with USDMF on PharmaCompass.
A Valganciclovir Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Valganciclovir Hydrochloride Certificate of Suitability (COS). The purpose of a Valganciclovir Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Valganciclovir Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Valganciclovir Hydrochloride to their clients by showing that a Valganciclovir Hydrochloride CEP has been issued for it. The manufacturer submits a Valganciclovir Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Valganciclovir Hydrochloride CEP holder for the record. Additionally, the data presented in the Valganciclovir Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Valganciclovir Hydrochloride DMF.
A Valganciclovir Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Valganciclovir Hydrochloride 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 Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Valganciclovir Hydrochloride written confirmation (Valganciclovir Hydrochloride WC) is an official document issued by a regulatory agency to a Valganciclovir Hydrochloride manufacturer, verifying that the manufacturing facility of a Valganciclovir Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Valganciclovir Hydrochloride APIs or Valganciclovir Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Valganciclovir Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Valganciclovir Hydrochloride 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 Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Valganciclovir Hydrochloride 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 Hydrochloride 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 Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Valganciclovir Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Valganciclovir Hydrochloride suppliers with NDC on PharmaCompass.
Valganciclovir Hydrochloride 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 Hydrochloride 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 Hydrochloride GMP manufacturer or Valganciclovir Hydrochloride GMP API supplier for your needs.
A Valganciclovir Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Valganciclovir Hydrochloride's compliance with Valganciclovir Hydrochloride specifications and serves as a tool for batch-level quality control.
Valganciclovir Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Valganciclovir Hydrochloride 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 Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Valganciclovir Hydrochloride EP), Valganciclovir Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Valganciclovir Hydrochloride USP).
