Synopsis
0
VMF
0
Canada
0
Australia
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : Complete
Rev. Date : 2022-03-09
Pay. Date : 2022-02-08
DMF Number : 22898
Submission : 2009-05-22
Status :
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34731
Submission : 2020-05-12
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-10
Pay. Date : 2017-02-22
DMF Number : 21005
Submission : 2007-11-02
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Registration Number : 302MF10110
Registrant's Address : Flat No. 302, Bhanu Enclave, Sunder Nagar, Erragadda, Hyderabad - 500038, Telangana, ...
Initial Date of Registration : 2020-09-14
Latest Date of Registration : 2020-09-14
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Levocetirizine Dihydrochloride USP
Date of Issue : 2024-04-03
Valid Till : 2027-01-21
Written Confirmation Number : WC-0493
Address of the Firm : Unit-IV, Plot No: 34B, 40B & 60B, J.N. Pharma City, Thanam (V), Parawada (M), An...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Levocetirizine Dihydrochloride IH
Date of Issue : 2025-05-28
Valid Till : 2028-06-25
Written Confirmation Number : WC-0035
Address of the Firm : Chemical Technical Operations, Unit -Ill, Plot No. 116,Sri Venkateswara Co-opera...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Registrant Name : Hiple Co., Ltd.
Registration Date : 2016-05-02
Registration Number : 20090720-40-C-258-15(3)
Manufacturer Name : Granules India Limited
Manufacturer Address : Plot No 8, Jawaharlal Nehru Pharma City, Tadi Village, Parawada Mandal, Vitsakhapatna...
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Registrant Name : Dongkwang Pharmaceutical Co., Ltd.
Registration Date : 2016-02-25
Registration Number : 20090720-40-C-258-15(2)
Manufacturer Name : Granules India Limited
Manufacturer Address : Plot No 8, Jawaharlal Nehru Pharma City, Tadi Village, Parawada Mandal, Vitsakhapatna...
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2009-07-20
Registration Number : 20090720-40-C-258-15
Manufacturer Name : Granules India Limited_x000D...
Manufacturer Address : Plot No 8, Jawaharlal Nehru Pharma City, Tadi Village, Parawada Mandal, Vitsakhapatna...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - SOLUTION;ORAL - 2.5MG/5ML
USFDA APPLICATION NUMBER - 209090
DOSAGE - TABLET;ORAL - 5MG **Federal Register...DOSAGE - TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22064
DOSAGE - SOLUTION;ORAL - 2.5MG/5ML **Federal ...DOSAGE - SOLUTION;ORAL - 2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22157
Related Excipient Companies
EUROAPI
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharm-RX Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kirsch Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ACG Worldwide
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Bioplus Life Sciences
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Clariant
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Corel Pharma Chem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Esteem Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Keval Exports
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kima Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Bold Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nitika Pharmaceutical Specialities
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nomisma Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qianhao Chemical (Hebei) Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qualicaps
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Silverline Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Vasa Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Zhejiang Huakang Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Coating Systems & Additives
Fillers, Diluents & Binders
Thickeners and Stabilizers
Direct Compression
Granulation
Controlled & Modified Release
Solubilizers
Disintegrants & Superdisintegrants
Topical
Parenteral
Film Formers & Plasticizers
Taste Masking
Lubricants & Glidants
Co-Processed Excipients
Emulsifying Agents
Rheology Modifiers
Chewable & Orodispersible Aids
Empty Capsules
API Stability Enhancers
Vegetarian Capsules
Surfactant & Foaming Agents
Coloring Agents
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
REF. STANDARDS & IMPURITIES
ANALYTICAL
ABOUT THIS PAGE
74
PharmaCompass offers a list of Levocetirizine Dihydrochloride 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 Levocetirizine Dihydrochloride manufacturer or Levocetirizine Dihydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Levocetirizine Dihydrochloride manufacturer or Levocetirizine Dihydrochloride supplier.
PharmaCompass also assists you with knowing the Levocetirizine Dihydrochloride API Price utilized in the formulation of products. Levocetirizine Dihydrochloride API Price is not always fixed or binding as the Levocetirizine Dihydrochloride Price is obtained through a variety of data sources. The Levocetirizine Dihydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Levocetirizine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Levocetirizine, including repackagers and relabelers. The FDA regulates Levocetirizine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Levocetirizine 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 Levocetirizine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Levocetirizine supplier is an individual or a company that provides Levocetirizine active pharmaceutical ingredient (API) or Levocetirizine finished formulations upon request. The Levocetirizine suppliers may include Levocetirizine API manufacturers, exporters, distributors and traders.
click here to find a list of Levocetirizine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Levocetirizine DMF (Drug Master File) is a document detailing the whole manufacturing process of Levocetirizine active pharmaceutical ingredient (API) in detail. Different forms of Levocetirizine DMFs exist exist since differing nations have different regulations, such as Levocetirizine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Levocetirizine DMF submitted to regulatory agencies in the US is known as a USDMF. Levocetirizine USDMF includes data on Levocetirizine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Levocetirizine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Levocetirizine 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 Levocetirizine Drug Master File in Japan (Levocetirizine JDMF) empowers Levocetirizine 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 Levocetirizine JDMF during the approval evaluation for pharmaceutical products. At the time of Levocetirizine 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 Levocetirizine suppliers with JDMF 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 Levocetirizine Drug Master File in Korea (Levocetirizine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Levocetirizine. The MFDS reviews the Levocetirizine KDMF as part of the drug registration process and uses the information provided in the Levocetirizine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Levocetirizine 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 Levocetirizine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Levocetirizine suppliers with KDMF on PharmaCompass.
A Levocetirizine CEP of the European Pharmacopoeia monograph is often referred to as a Levocetirizine Certificate of Suitability (COS). The purpose of a Levocetirizine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Levocetirizine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Levocetirizine to their clients by showing that a Levocetirizine CEP has been issued for it. The manufacturer submits a Levocetirizine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Levocetirizine CEP holder for the record. Additionally, the data presented in the Levocetirizine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Levocetirizine DMF.
A Levocetirizine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Levocetirizine 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 Levocetirizine suppliers with CEP (COS) on PharmaCompass.
A Levocetirizine written confirmation (Levocetirizine WC) is an official document issued by a regulatory agency to a Levocetirizine manufacturer, verifying that the manufacturing facility of a Levocetirizine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Levocetirizine APIs or Levocetirizine finished pharmaceutical products to another nation, regulatory agencies frequently require a Levocetirizine WC (written confirmation) as part of the regulatory process.
click here to find a list of Levocetirizine 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 Levocetirizine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Levocetirizine 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 Levocetirizine 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 Levocetirizine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Levocetirizine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Levocetirizine suppliers with NDC on PharmaCompass.
Levocetirizine 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 Levocetirizine 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 Levocetirizine GMP manufacturer or Levocetirizine GMP API supplier for your needs.
A Levocetirizine CoA (Certificate of Analysis) is a formal document that attests to Levocetirizine's compliance with Levocetirizine specifications and serves as a tool for batch-level quality control.
Levocetirizine CoA mostly includes findings from lab analyses of a specific batch. For each Levocetirizine 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.
Levocetirizine may be tested according to a variety of international standards, such as European Pharmacopoeia (Levocetirizine EP), Levocetirizine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Levocetirizine USP).
