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Australia
DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-05
Pay. Date : 2014-05-29
DMF Number : 5876
Submission : 1985-06-10
Status :
Type : II
Apex Healthcare Limited: ISO 9001:2008, WHO-GMP, US FDA-audited manufacturer & exporter of APIs, bulk drugs, and formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39139
Submission : 2023-12-01
Status :
Type : II
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DOSAGE - INJECTABLE;INJECTION - 4%
USFDA APPLICATION NUMBER - 10417
DOSAGE - INJECTABLE;INJECTION - 1% **Federal ...DOSAGE - INJECTABLE;INJECTION - 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 16801
DOSAGE - INJECTABLE;INJECTION - 2% **Federal ...DOSAGE - INJECTABLE;INJECTION - 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 16801
DOSAGE - INJECTABLE;INJECTION - 20% **Federal...DOSAGE - INJECTABLE;INJECTION - 20% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 16801
DOSAGE - INJECTABLE;INJECTION - 4% **Federal ...DOSAGE - INJECTABLE;INJECTION - 4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 16801
DOSAGE - INJECTABLE;INJECTION - 0.005MG/ML;0....DOSAGE - INJECTABLE;INJECTION - 0.005MG/ML;0.5%
USFDA APPLICATION NUMBER - 6488
DOSAGE - INJECTABLE;INJECTION - 0.005MG/ML;1%
USFDA APPLICATION NUMBER - 6488
DOSAGE - INJECTABLE;INJECTION - 0.005MG/ML;1....DOSAGE - INJECTABLE;INJECTION - 0.005MG/ML;1.5%
USFDA APPLICATION NUMBER - 6488
DOSAGE - INJECTABLE;INJECTION - 0.005MG/ML;2%
USFDA APPLICATION NUMBER - 6488
DOSAGE - INJECTABLE;INJECTION - 0.01MG/ML;1%
USFDA APPLICATION NUMBER - 6488
DOSAGE - INJECTABLE;INJECTION - 0.01MG/ML;2%
USFDA APPLICATION NUMBER - 6488
DOSAGE - INJECTABLE;INJECTION - 0.02MG/ML;2%
USFDA APPLICATION NUMBER - 6488
DOSAGE - INJECTABLE;INJECTION - 0.5%
USFDA APPLICATION NUMBER - 6488
DOSAGE - INJECTABLE;INJECTION - 1%
USFDA APPLICATION NUMBER - 6488
DOSAGE - INJECTABLE;INJECTION - 1.5%
USFDA APPLICATION NUMBER - 6488
DOSAGE - INJECTABLE;INJECTION - 2%
USFDA APPLICATION NUMBER - 6488
DOSAGE - INJECTABLE;INJECTION - 1%
USFDA APPLICATION NUMBER - 83158
DOSAGE - INJECTABLE;INJECTION - 2%
USFDA APPLICATION NUMBER - 83158
DOSAGE - INJECTABLE;INJECTION - 1%
USFDA APPLICATION NUMBER - 83173
DOSAGE - INJECTABLE;SPINAL - 5%
USFDA APPLICATION NUMBER - 83914
DOSAGE - JELLY;TOPICAL - 2% **Federal Registe...DOSAGE - JELLY;TOPICAL - 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 8816
DOSAGE - INJECTABLE;INJECTION - EQ 0.02MG BAS...DOSAGE - INJECTABLE;INJECTION - EQ 0.02MG BASE/ML;2%
USFDA APPLICATION NUMBER - 88389
DOSAGE - INJECTABLE;INJECTION - EQ 0.01MG BAS...DOSAGE - INJECTABLE;INJECTION - EQ 0.01MG BASE/ML;2%
USFDA APPLICATION NUMBER - 88390
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ABOUT THIS PAGE
52
PharmaCompass offers a list of Lidocaine Hydrochloride 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 Lidocaine Hydrochloride manufacturer or Lidocaine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lidocaine Hydrochloride manufacturer or Lidocaine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Lidocaine Hydrochloride API Price utilized in the formulation of products. Lidocaine Hydrochloride API Price is not always fixed or binding as the Lidocaine Hydrochloride Price is obtained through a variety of data sources. The Lidocaine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A LIDOCAINE HCL VISCOUS manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of LIDOCAINE HCL VISCOUS, including repackagers and relabelers. The FDA regulates LIDOCAINE HCL VISCOUS manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. LIDOCAINE HCL VISCOUS 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 LIDOCAINE HCL VISCOUS manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A LIDOCAINE HCL VISCOUS supplier is an individual or a company that provides LIDOCAINE HCL VISCOUS active pharmaceutical ingredient (API) or LIDOCAINE HCL VISCOUS finished formulations upon request. The LIDOCAINE HCL VISCOUS suppliers may include LIDOCAINE HCL VISCOUS API manufacturers, exporters, distributors and traders.
click here to find a list of LIDOCAINE HCL VISCOUS suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A LIDOCAINE HCL VISCOUS DMF (Drug Master File) is a document detailing the whole manufacturing process of LIDOCAINE HCL VISCOUS active pharmaceutical ingredient (API) in detail. Different forms of LIDOCAINE HCL VISCOUS DMFs exist exist since differing nations have different regulations, such as LIDOCAINE HCL VISCOUS USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A LIDOCAINE HCL VISCOUS DMF submitted to regulatory agencies in the US is known as a USDMF. LIDOCAINE HCL VISCOUS USDMF includes data on LIDOCAINE HCL VISCOUS's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The LIDOCAINE HCL VISCOUS USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of LIDOCAINE HCL VISCOUS 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 LIDOCAINE HCL VISCOUS Drug Master File in Japan (LIDOCAINE HCL VISCOUS JDMF) empowers LIDOCAINE HCL VISCOUS 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 LIDOCAINE HCL VISCOUS JDMF during the approval evaluation for pharmaceutical products. At the time of LIDOCAINE HCL VISCOUS 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 LIDOCAINE HCL VISCOUS 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 LIDOCAINE HCL VISCOUS Drug Master File in Korea (LIDOCAINE HCL VISCOUS KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of LIDOCAINE HCL VISCOUS. The MFDS reviews the LIDOCAINE HCL VISCOUS KDMF as part of the drug registration process and uses the information provided in the LIDOCAINE HCL VISCOUS KDMF to evaluate the safety and efficacy of the drug.
After submitting a LIDOCAINE HCL VISCOUS 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 LIDOCAINE HCL VISCOUS API can apply through the Korea Drug Master File (KDMF).
click here to find a list of LIDOCAINE HCL VISCOUS suppliers with KDMF on PharmaCompass.
A LIDOCAINE HCL VISCOUS CEP of the European Pharmacopoeia monograph is often referred to as a LIDOCAINE HCL VISCOUS Certificate of Suitability (COS). The purpose of a LIDOCAINE HCL VISCOUS CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of LIDOCAINE HCL VISCOUS EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of LIDOCAINE HCL VISCOUS to their clients by showing that a LIDOCAINE HCL VISCOUS CEP has been issued for it. The manufacturer submits a LIDOCAINE HCL VISCOUS CEP (COS) as part of the market authorization procedure, and it takes on the role of a LIDOCAINE HCL VISCOUS CEP holder for the record. Additionally, the data presented in the LIDOCAINE HCL VISCOUS CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the LIDOCAINE HCL VISCOUS DMF.
A LIDOCAINE HCL VISCOUS CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. LIDOCAINE HCL VISCOUS 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 LIDOCAINE HCL VISCOUS suppliers with CEP (COS) on PharmaCompass.
A LIDOCAINE HCL VISCOUS written confirmation (LIDOCAINE HCL VISCOUS WC) is an official document issued by a regulatory agency to a LIDOCAINE HCL VISCOUS manufacturer, verifying that the manufacturing facility of a LIDOCAINE HCL VISCOUS active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting LIDOCAINE HCL VISCOUS APIs or LIDOCAINE HCL VISCOUS finished pharmaceutical products to another nation, regulatory agencies frequently require a LIDOCAINE HCL VISCOUS WC (written confirmation) as part of the regulatory process.
click here to find a list of LIDOCAINE HCL VISCOUS 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 LIDOCAINE HCL VISCOUS as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for LIDOCAINE HCL VISCOUS 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 LIDOCAINE HCL VISCOUS 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 LIDOCAINE HCL VISCOUS and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a LIDOCAINE HCL VISCOUS NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of LIDOCAINE HCL VISCOUS suppliers with NDC on PharmaCompass.
LIDOCAINE HCL VISCOUS 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 LIDOCAINE HCL VISCOUS 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 LIDOCAINE HCL VISCOUS GMP manufacturer or LIDOCAINE HCL VISCOUS GMP API supplier for your needs.
A LIDOCAINE HCL VISCOUS CoA (Certificate of Analysis) is a formal document that attests to LIDOCAINE HCL VISCOUS's compliance with LIDOCAINE HCL VISCOUS specifications and serves as a tool for batch-level quality control.
LIDOCAINE HCL VISCOUS CoA mostly includes findings from lab analyses of a specific batch. For each LIDOCAINE HCL VISCOUS 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.
LIDOCAINE HCL VISCOUS may be tested according to a variety of international standards, such as European Pharmacopoeia (LIDOCAINE HCL VISCOUS EP), LIDOCAINE HCL VISCOUS JP (Japanese Pharmacopeia) and the US Pharmacopoeia (LIDOCAINE HCL VISCOUS USP).
