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API SUPPLIERS
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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
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-17
Pay. Date : 2013-08-07
DMF Number : 21417
Submission : 2008-03-11
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
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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...
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...
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Registrant Name : Toru Corporation
Registration Date : 2020-01-30
Registration Number : 20110429-40-C-279-18(1)
Manufacturer Name : RA Chem Pharma Limited
Manufacturer Address : RS 50/1, Mukteswarapuram Village,Jaggaiahpeta Mandal, Krishna District-521 175. Andhr...
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Registrant Name : Klasia Co., Ltd.
Registration Date : 2022-06-03
Registration Number : 20110429-40-C-279-18(2)
Manufacturer Name : Cohance Lifesciences Limited
Manufacturer Address : RS No.50/1, Mukteswarapuram Village, Jaggaiahpet Mandal, NTR District-521 457, Andhra...
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2011-04-29
Registration Number : 20110429-40-C-279-18
Manufacturer Name : Cohance Lifesciences Limited
Manufacturer Address : RS No.50/1, Mukteswarapuram Village, Jaggaiahpet Mandal, NTR District-521 457, Andhra...
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Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Levocetirizine Dihydrochloride
About the Company : Granules is a fast-growing, vertically integrated pharmaceutical company headquartered in Hyderabad, committed to operational excellence, quality, and customer service. It manufact...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Levocetirizine Dihydrochloride
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Levocetirizine Dihydrochloride
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Levocetirizine Dihydrochloride
About the Company : Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commercialzation. With our...
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Levocetirizine Dihydrochloride
About the Company : DKSH, founded with the goal of improving people's lives, assists businesses with market expansion and business growth in both existing and emerging markets. It has been fostering g...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Levocetirizine Dihydrochloride
About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Levocetirizine Dihydrochloride
About the Company : Egis is a member of the Servier Group. Egis’ products are manufactured at 3 production sites in Hungary, which are certified by EMA,FDA, ANVISA, PMDA ,KFDA. Egis sells its produc...
Jai Radhe Sales is your partner for all your sourcing needs.
Levocetirizine Dihydrochloride
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Levocetirizine Dihydrochloride
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Levocetirizine Dihydrochloride
About the Company : Octavius Pharma is a global leader in Directly Compressible Granules with over 40 years of experience in Formulation development, manufacturing and commercialization. It offers a w...
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
Lead Product(s) : Levocetirizine Dihydrochloride
Therapeutic Area : Immunology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
ATHENA’s First Launch in Russia with Levocetirizine ODT
Details : Levocetirizine ODT is second-generation piperazine derivative with potent H1-selective antihistaminic activity,n Improved oral bioavailability and onset of action vs. conventional oral slide form by avoiding hepatic first-pass effect.
Product Name : Levocetirizine-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 10, 2020
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Regulatory Info : Generic
Registration Country : South Africa
Levocetirizine dihydrochloride
Brand Name : Cetlovo
Dosage Form : FCT
Dosage Strength : 5mg
Packaging : 10X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Levocetirizine dihydrochloride
Brand Name : Cetlovo
Dosage Form : FCT
Dosage Strength : 5mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
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Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.
Regulatory Info :
Registration Country : France
Levocetirizine Dihydrochloride
Brand Name : Levocetirizine
Dosage Form : Oro-Dispersible Tablet
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : France
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Levocetirizine Dihydrochloride
Brand Name : Levocetirizine Dihydro...
Dosage Form : DC Granules
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Levocetirizine Dihydrochloride
Brand Name : Levocetirizine Dihydro...
Dosage Form : Tablet
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
Regulatory Info :
Registration Country : India
Levocetirizine Dihydrochloride
Brand Name : Levocetirizine Dihydro...
Dosage Form : Tablet
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
Regulatory Info : Generic
Registration Country : India
Levocetirizine Dihydrochloride
Brand Name : Leocet
Dosage Form : Tablet
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : India
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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
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REF. STANDARDS & IMPURITIES
ANALYTICAL
ABOUT THIS PAGE
59
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 LEVO CETIRIZINE DIHYDROCHLORIDE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of LEVO CETIRIZINE DIHYDROCHLORIDE, including repackagers and relabelers. The FDA regulates LEVO CETIRIZINE DIHYDROCHLORIDE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. LEVO CETIRIZINE DIHYDROCHLORIDE 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 LEVO CETIRIZINE DIHYDROCHLORIDE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A LEVO CETIRIZINE DIHYDROCHLORIDE supplier is an individual or a company that provides LEVO CETIRIZINE DIHYDROCHLORIDE active pharmaceutical ingredient (API) or LEVO CETIRIZINE DIHYDROCHLORIDE finished formulations upon request. The LEVO CETIRIZINE DIHYDROCHLORIDE suppliers may include LEVO CETIRIZINE DIHYDROCHLORIDE API manufacturers, exporters, distributors and traders.
click here to find a list of LEVO CETIRIZINE DIHYDROCHLORIDE suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A LEVO CETIRIZINE DIHYDROCHLORIDE DMF (Drug Master File) is a document detailing the whole manufacturing process of LEVO CETIRIZINE DIHYDROCHLORIDE active pharmaceutical ingredient (API) in detail. Different forms of LEVO CETIRIZINE DIHYDROCHLORIDE DMFs exist exist since differing nations have different regulations, such as LEVO CETIRIZINE DIHYDROCHLORIDE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A LEVO CETIRIZINE DIHYDROCHLORIDE DMF submitted to regulatory agencies in the US is known as a USDMF. LEVO CETIRIZINE DIHYDROCHLORIDE USDMF includes data on LEVO CETIRIZINE DIHYDROCHLORIDE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The LEVO CETIRIZINE DIHYDROCHLORIDE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of LEVO CETIRIZINE DIHYDROCHLORIDE 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 LEVO CETIRIZINE DIHYDROCHLORIDE Drug Master File in Japan (LEVO CETIRIZINE DIHYDROCHLORIDE JDMF) empowers LEVO CETIRIZINE DIHYDROCHLORIDE 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 LEVO CETIRIZINE DIHYDROCHLORIDE JDMF during the approval evaluation for pharmaceutical products. At the time of LEVO CETIRIZINE DIHYDROCHLORIDE 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 LEVO CETIRIZINE DIHYDROCHLORIDE 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 LEVO CETIRIZINE DIHYDROCHLORIDE Drug Master File in Korea (LEVO CETIRIZINE DIHYDROCHLORIDE KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of LEVO CETIRIZINE DIHYDROCHLORIDE. The MFDS reviews the LEVO CETIRIZINE DIHYDROCHLORIDE KDMF as part of the drug registration process and uses the information provided in the LEVO CETIRIZINE DIHYDROCHLORIDE KDMF to evaluate the safety and efficacy of the drug.
After submitting a LEVO CETIRIZINE DIHYDROCHLORIDE 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 LEVO CETIRIZINE DIHYDROCHLORIDE API can apply through the Korea Drug Master File (KDMF).
click here to find a list of LEVO CETIRIZINE DIHYDROCHLORIDE suppliers with KDMF on PharmaCompass.
A LEVO CETIRIZINE DIHYDROCHLORIDE CEP of the European Pharmacopoeia monograph is often referred to as a LEVO CETIRIZINE DIHYDROCHLORIDE Certificate of Suitability (COS). The purpose of a LEVO CETIRIZINE DIHYDROCHLORIDE CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of LEVO CETIRIZINE DIHYDROCHLORIDE EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of LEVO CETIRIZINE DIHYDROCHLORIDE to their clients by showing that a LEVO CETIRIZINE DIHYDROCHLORIDE CEP has been issued for it. The manufacturer submits a LEVO CETIRIZINE DIHYDROCHLORIDE CEP (COS) as part of the market authorization procedure, and it takes on the role of a LEVO CETIRIZINE DIHYDROCHLORIDE CEP holder for the record. Additionally, the data presented in the LEVO CETIRIZINE DIHYDROCHLORIDE CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the LEVO CETIRIZINE DIHYDROCHLORIDE DMF.
A LEVO CETIRIZINE DIHYDROCHLORIDE CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. LEVO CETIRIZINE DIHYDROCHLORIDE 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 LEVO CETIRIZINE DIHYDROCHLORIDE suppliers with CEP (COS) on PharmaCompass.
A LEVO CETIRIZINE DIHYDROCHLORIDE written confirmation (LEVO CETIRIZINE DIHYDROCHLORIDE WC) is an official document issued by a regulatory agency to a LEVO CETIRIZINE DIHYDROCHLORIDE manufacturer, verifying that the manufacturing facility of a LEVO CETIRIZINE DIHYDROCHLORIDE active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting LEVO CETIRIZINE DIHYDROCHLORIDE APIs or LEVO CETIRIZINE DIHYDROCHLORIDE finished pharmaceutical products to another nation, regulatory agencies frequently require a LEVO CETIRIZINE DIHYDROCHLORIDE WC (written confirmation) as part of the regulatory process.
click here to find a list of LEVO CETIRIZINE DIHYDROCHLORIDE 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 LEVO CETIRIZINE DIHYDROCHLORIDE as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for LEVO CETIRIZINE DIHYDROCHLORIDE 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 LEVO CETIRIZINE DIHYDROCHLORIDE 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 LEVO CETIRIZINE DIHYDROCHLORIDE and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a LEVO CETIRIZINE DIHYDROCHLORIDE NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of LEVO CETIRIZINE DIHYDROCHLORIDE suppliers with NDC on PharmaCompass.
LEVO CETIRIZINE DIHYDROCHLORIDE 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 LEVO CETIRIZINE DIHYDROCHLORIDE 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 LEVO CETIRIZINE DIHYDROCHLORIDE GMP manufacturer or LEVO CETIRIZINE DIHYDROCHLORIDE GMP API supplier for your needs.
A LEVO CETIRIZINE DIHYDROCHLORIDE CoA (Certificate of Analysis) is a formal document that attests to LEVO CETIRIZINE DIHYDROCHLORIDE's compliance with LEVO CETIRIZINE DIHYDROCHLORIDE specifications and serves as a tool for batch-level quality control.
LEVO CETIRIZINE DIHYDROCHLORIDE CoA mostly includes findings from lab analyses of a specific batch. For each LEVO CETIRIZINE DIHYDROCHLORIDE 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.
LEVO CETIRIZINE DIHYDROCHLORIDE may be tested according to a variety of international standards, such as European Pharmacopoeia (LEVO CETIRIZINE DIHYDROCHLORIDE EP), LEVO CETIRIZINE DIHYDROCHLORIDE JP (Japanese Pharmacopeia) and the US Pharmacopoeia (LEVO CETIRIZINE DIHYDROCHLORIDE USP).
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