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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
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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 - TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.2...DOSAGE - TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.2MG BASE
USFDA APPLICATION NUMBER - 20747
DOSAGE - TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.4...DOSAGE - TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.4MG BASE
USFDA APPLICATION NUMBER - 20747
DOSAGE - TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.6...DOSAGE - TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.6MG BASE
USFDA APPLICATION NUMBER - 20747
DOSAGE - TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.8...DOSAGE - TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.8MG BASE
USFDA APPLICATION NUMBER - 20747
DOSAGE - TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.2...DOSAGE - TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.2MG BASE
USFDA APPLICATION NUMBER - 20747
DOSAGE - TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.6...DOSAGE - TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.6MG BASE
USFDA APPLICATION NUMBER - 20747
DOSAGE - TABLET;BUCCAL, SUBLINGUAL - EQ 0.1MG...DOSAGE - TABLET;BUCCAL, SUBLINGUAL - EQ 0.1MG BASE
USFDA APPLICATION NUMBER - 21947
DOSAGE - TABLET;BUCCAL, SUBLINGUAL - EQ 0.2MG...DOSAGE - TABLET;BUCCAL, SUBLINGUAL - EQ 0.2MG BASE
USFDA APPLICATION NUMBER - 21947
DOSAGE - TABLET;BUCCAL, SUBLINGUAL - EQ 0.3MG...DOSAGE - TABLET;BUCCAL, SUBLINGUAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21947
DOSAGE - TABLET;BUCCAL, SUBLINGUAL - EQ 0.4MG...DOSAGE - TABLET;BUCCAL, SUBLINGUAL - EQ 0.4MG BASE
USFDA APPLICATION NUMBER - 21947
DOSAGE - TABLET;BUCCAL, SUBLINGUAL - EQ 0.6MG...DOSAGE - TABLET;BUCCAL, SUBLINGUAL - EQ 0.6MG BASE
USFDA APPLICATION NUMBER - 21947
DOSAGE - TABLET;BUCCAL, SUBLINGUAL - EQ 0.8MG...DOSAGE - TABLET;BUCCAL, SUBLINGUAL - EQ 0.8MG BASE
USFDA APPLICATION NUMBER - 21947
DOSAGE - TABLET;SUBLINGUAL - EQ 0.1MG BASE **...DOSAGE - TABLET;SUBLINGUAL - EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22510
DOSAGE - TABLET;SUBLINGUAL - EQ 0.2MG BASE **...DOSAGE - TABLET;SUBLINGUAL - EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22510
DOSAGE - TABLET;SUBLINGUAL - EQ 0.3MG BASE **...DOSAGE - TABLET;SUBLINGUAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22510
DOSAGE - TABLET;SUBLINGUAL - EQ 0.4MG BASE **...DOSAGE - TABLET;SUBLINGUAL - EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22510
DOSAGE - TABLET;SUBLINGUAL - EQ 0.6MG BASE **...DOSAGE - TABLET;SUBLINGUAL - EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22510
DOSAGE - TABLET;SUBLINGUAL - EQ 0.8MG BASE **...DOSAGE - TABLET;SUBLINGUAL - EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22510
DOSAGE - SPRAY, METERED;NASAL - EQ 0.1MG BASE...DOSAGE - SPRAY, METERED;NASAL - EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22569
DOSAGE - SPRAY, METERED;NASAL - EQ 0.3MG BASE...DOSAGE - SPRAY, METERED;NASAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22569
DOSAGE - SPRAY, METERED;NASAL - EQ 0.4MG BASE...DOSAGE - SPRAY, METERED;NASAL - EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22569
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Fentanyl Citrate 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 Fentanyl Citrate manufacturer or Fentanyl Citrate supplier for your needs.
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A LAZANDA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of LAZANDA, including repackagers and relabelers. The FDA regulates LAZANDA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. LAZANDA 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 LAZANDA manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A LAZANDA supplier is an individual or a company that provides LAZANDA active pharmaceutical ingredient (API) or LAZANDA finished formulations upon request. The LAZANDA suppliers may include LAZANDA API manufacturers, exporters, distributors and traders.
click here to find a list of LAZANDA suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A LAZANDA DMF (Drug Master File) is a document detailing the whole manufacturing process of LAZANDA active pharmaceutical ingredient (API) in detail. Different forms of LAZANDA DMFs exist exist since differing nations have different regulations, such as LAZANDA USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A LAZANDA DMF submitted to regulatory agencies in the US is known as a USDMF. LAZANDA USDMF includes data on LAZANDA's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The LAZANDA USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of LAZANDA 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 LAZANDA Drug Master File in Japan (LAZANDA JDMF) empowers LAZANDA 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 LAZANDA JDMF during the approval evaluation for pharmaceutical products. At the time of LAZANDA 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 LAZANDA 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 LAZANDA Drug Master File in Korea (LAZANDA KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of LAZANDA. The MFDS reviews the LAZANDA KDMF as part of the drug registration process and uses the information provided in the LAZANDA KDMF to evaluate the safety and efficacy of the drug.
After submitting a LAZANDA 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 LAZANDA API can apply through the Korea Drug Master File (KDMF).
click here to find a list of LAZANDA suppliers with KDMF on PharmaCompass.
A LAZANDA CEP of the European Pharmacopoeia monograph is often referred to as a LAZANDA Certificate of Suitability (COS). The purpose of a LAZANDA CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of LAZANDA EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of LAZANDA to their clients by showing that a LAZANDA CEP has been issued for it. The manufacturer submits a LAZANDA CEP (COS) as part of the market authorization procedure, and it takes on the role of a LAZANDA CEP holder for the record. Additionally, the data presented in the LAZANDA CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the LAZANDA DMF.
A LAZANDA CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. LAZANDA 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 LAZANDA suppliers with CEP (COS) on PharmaCompass.
A LAZANDA written confirmation (LAZANDA WC) is an official document issued by a regulatory agency to a LAZANDA manufacturer, verifying that the manufacturing facility of a LAZANDA active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting LAZANDA APIs or LAZANDA finished pharmaceutical products to another nation, regulatory agencies frequently require a LAZANDA WC (written confirmation) as part of the regulatory process.
click here to find a list of LAZANDA 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 LAZANDA as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for LAZANDA 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 LAZANDA 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 LAZANDA and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a LAZANDA NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of LAZANDA suppliers with NDC on PharmaCompass.
LAZANDA 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 LAZANDA 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 LAZANDA GMP manufacturer or LAZANDA GMP API supplier for your needs.
A LAZANDA CoA (Certificate of Analysis) is a formal document that attests to LAZANDA's compliance with LAZANDA specifications and serves as a tool for batch-level quality control.
LAZANDA CoA mostly includes findings from lab analyses of a specific batch. For each LAZANDA 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.
LAZANDA may be tested according to a variety of international standards, such as European Pharmacopoeia (LAZANDA EP), LAZANDA JP (Japanese Pharmacopeia) and the US Pharmacopoeia (LAZANDA USP).
