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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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Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
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Dr. Paul Lohmann® provides premium mineral salts backed by 140+ years of innovation, quality manufacturing, and global expertise.
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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 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).
