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API SUPPLIERS
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
ASMF, CN 
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Emay Pharmaceuticals is a GMP-certified API manufacturing company.
Jai Radhe Sales is your partner for all your sourcing needs.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
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USDMF
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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
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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/EP
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...
Vital Laboratories – Trusted Global API Manufacturer of Quinine, Hyoscine, Antimalarials & Vitamins
Levocetirizine Dihydrochloride USP
Date of Issue : 2024-05-20
Valid Till : 2027-01-08
Written Confirmation Number : WC-0300
Address of the Firm : Plot No. 1710, Phase-lll, G.I.D.C Estate, Vapi-396195, Dist.-Valsad, Gujarat, In...
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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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ABOUT THIS PAGE
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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 Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Levocetirizine Hydrochloride, including repackagers and relabelers. The FDA regulates Levocetirizine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Levocetirizine 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 Levocetirizine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Levocetirizine Hydrochloride supplier is an individual or a company that provides Levocetirizine Hydrochloride active pharmaceutical ingredient (API) or Levocetirizine Hydrochloride finished formulations upon request. The Levocetirizine Hydrochloride suppliers may include Levocetirizine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Levocetirizine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Levocetirizine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Levocetirizine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Levocetirizine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Levocetirizine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Levocetirizine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Levocetirizine Hydrochloride USDMF includes data on Levocetirizine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Levocetirizine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Levocetirizine Hydrochloride 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 Hydrochloride Drug Master File in Japan (Levocetirizine Hydrochloride JDMF) empowers Levocetirizine Hydrochloride 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 Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Levocetirizine Hydrochloride 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 Hydrochloride 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 Hydrochloride Drug Master File in Korea (Levocetirizine Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Levocetirizine Hydrochloride. The MFDS reviews the Levocetirizine Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Levocetirizine Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Levocetirizine 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 Levocetirizine Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Levocetirizine Hydrochloride suppliers with KDMF on PharmaCompass.
A Levocetirizine Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Levocetirizine Hydrochloride Certificate of Suitability (COS). The purpose of a Levocetirizine Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Levocetirizine Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Levocetirizine Hydrochloride to their clients by showing that a Levocetirizine Hydrochloride CEP has been issued for it. The manufacturer submits a Levocetirizine Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Levocetirizine Hydrochloride CEP holder for the record. Additionally, the data presented in the Levocetirizine Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Levocetirizine Hydrochloride DMF.
A Levocetirizine Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Levocetirizine 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 Levocetirizine Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Levocetirizine Hydrochloride written confirmation (Levocetirizine Hydrochloride WC) is an official document issued by a regulatory agency to a Levocetirizine Hydrochloride manufacturer, verifying that the manufacturing facility of a Levocetirizine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Levocetirizine Hydrochloride APIs or Levocetirizine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Levocetirizine Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Levocetirizine 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 Levocetirizine Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Levocetirizine 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 Levocetirizine 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 Levocetirizine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Levocetirizine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Levocetirizine Hydrochloride suppliers with NDC on PharmaCompass.
Levocetirizine 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 Levocetirizine 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 Levocetirizine Hydrochloride GMP manufacturer or Levocetirizine Hydrochloride GMP API supplier for your needs.
A Levocetirizine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Levocetirizine Hydrochloride's compliance with Levocetirizine Hydrochloride specifications and serves as a tool for batch-level quality control.
Levocetirizine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Levocetirizine 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.
Levocetirizine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Levocetirizine Hydrochloride EP), Levocetirizine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Levocetirizine Hydrochloride USP).
