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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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Jai Radhe Sales is your partner for all your sourcing needs.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
Harika Drugs has been providing a qualitative range of Bulk Drugs/ APIs since 1993.
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USDMF
GDUFA
DMF Review : Complete
Rev. Date : 2024-03-12
Pay. Date : 2023-12-01
DMF Number : 35249
Submission : 2023-12-05
Status :
Type : II
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - INJECTABLE;INJECTION - 25MG/ML **Fed...DOSAGE - INJECTABLE;INJECTION - 25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 11111
DOSAGE - INJECTABLE;INJECTION - 50MG/ML **Fed...DOSAGE - INJECTABLE;INJECTION - 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 11111
DOSAGE - SYRUP;ORAL - 10MG/5ML
USFDA APPLICATION NUMBER - 87294
DOSAGE - INJECTABLE;INJECTION - 25MG/ML
USFDA APPLICATION NUMBER - 87408
DOSAGE - INJECTABLE;INJECTION - 50MG/ML
USFDA APPLICATION NUMBER - 87408
DOSAGE - TABLET;ORAL - 25MG
USFDA APPLICATION NUMBER - 88618
DOSAGE - TABLET;ORAL - 50MG
USFDA APPLICATION NUMBER - 88619
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PharmaCompass offers a list of Hydroxyzine 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 Hydroxyzine Hydrochloride manufacturer or Hydroxyzine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Hydroxyzine Hydrochloride manufacturer or Hydroxyzine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Hydroxyzine Hydrochloride API Price utilized in the formulation of products. Hydroxyzine Hydrochloride API Price is not always fixed or binding as the Hydroxyzine Hydrochloride Price is obtained through a variety of data sources. The Hydroxyzine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A hydroxyzin hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of hydroxyzin hydrochloride, including repackagers and relabelers. The FDA regulates hydroxyzin hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. hydroxyzin 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 hydroxyzin hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A hydroxyzin hydrochloride supplier is an individual or a company that provides hydroxyzin hydrochloride active pharmaceutical ingredient (API) or hydroxyzin hydrochloride finished formulations upon request. The hydroxyzin hydrochloride suppliers may include hydroxyzin hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of hydroxyzin hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A hydroxyzin hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of hydroxyzin hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of hydroxyzin hydrochloride DMFs exist exist since differing nations have different regulations, such as hydroxyzin hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A hydroxyzin hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. hydroxyzin hydrochloride USDMF includes data on hydroxyzin hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The hydroxyzin hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of hydroxyzin hydrochloride suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a hydroxyzin hydrochloride Drug Master File in Korea (hydroxyzin hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of hydroxyzin hydrochloride. The MFDS reviews the hydroxyzin hydrochloride KDMF as part of the drug registration process and uses the information provided in the hydroxyzin hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a hydroxyzin hydrochloride KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their hydroxyzin hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of hydroxyzin hydrochloride suppliers with KDMF on PharmaCompass.
A hydroxyzin hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a hydroxyzin hydrochloride Certificate of Suitability (COS). The purpose of a hydroxyzin hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of hydroxyzin hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of hydroxyzin hydrochloride to their clients by showing that a hydroxyzin hydrochloride CEP has been issued for it. The manufacturer submits a hydroxyzin hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a hydroxyzin hydrochloride CEP holder for the record. Additionally, the data presented in the hydroxyzin hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the hydroxyzin hydrochloride DMF.
A hydroxyzin hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. hydroxyzin 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 hydroxyzin hydrochloride suppliers with CEP (COS) on PharmaCompass.
A hydroxyzin hydrochloride written confirmation (hydroxyzin hydrochloride WC) is an official document issued by a regulatory agency to a hydroxyzin hydrochloride manufacturer, verifying that the manufacturing facility of a hydroxyzin hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting hydroxyzin hydrochloride APIs or hydroxyzin hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a hydroxyzin hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of hydroxyzin 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 hydroxyzin hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for hydroxyzin 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 hydroxyzin 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 hydroxyzin hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a hydroxyzin hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of hydroxyzin hydrochloride suppliers with NDC on PharmaCompass.
hydroxyzin 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 hydroxyzin 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 hydroxyzin hydrochloride GMP manufacturer or hydroxyzin hydrochloride GMP API supplier for your needs.
A hydroxyzin hydrochloride CoA (Certificate of Analysis) is a formal document that attests to hydroxyzin hydrochloride's compliance with hydroxyzin hydrochloride specifications and serves as a tool for batch-level quality control.
hydroxyzin hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each hydroxyzin 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.
hydroxyzin hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (hydroxyzin hydrochloride EP), hydroxyzin hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (hydroxyzin hydrochloride USP).
