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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
CEP/COS 
JDMF
NDC
ASMF
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
Nortec Quimica is the largest API manufacturer in Latin America.
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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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
Lidocaine Hydrochloride Monohydrate
Certificate Number : CEP 1996-020 - Rev 09
Status : Valid
Issue Date : 2024-05-29
Type : Chemical
Substance Number : 227
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
Registration Number : 219MF10205
Registrant's Address : Cesar Martinell i Brunet 12A, Poligono Rubi Sur, Rubi (Barcelona), Spain
Initial Date of Registration : 2007-06-13
Latest Date of Registration : 2021-04-02
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Drugs in Development
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
Regulatory Info :
Registration Country : Canada
Brand Name : XYLOCAINE JELLY 2%
Dosage Form : GEL
Dosage Strength : 20MG/ML
Packaging : 30ML
Approval Date :
Application Number : 1694
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : XYLOCAINE JELLY 2%
Dosage Form : GEL
Dosage Strength : 20MG/ML
Packaging : 10ML SYR
Approval Date :
Application Number : 385484
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : XYLOCAINE 2% W EPINEPHRINE 1:200000
Dosage Form : SOLUTION
Dosage Strength : 20MG/ML
Packaging : 10X20 ML
Approval Date :
Application Number : 284106
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : XYLOCAINE 1%
Dosage Form : SOLUTION
Dosage Strength : 10MG/ML
Packaging : 2ML/5ML/10ML
Approval Date :
Application Number : 1732
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : XYLOCAINE 2%
Dosage Form : SOLUTION
Dosage Strength : 20MG/ML
Packaging : 2/5/10ML
Approval Date :
Application Number : 36641
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : XYLOCAINE 1% W EPINEPHRINE 1:100000
Dosage Form : SOLUTION
Dosage Strength : 10MG/ML
Packaging : 20ML
Approval Date :
Application Number : 1791
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : XYLOCAINE 1% W EPINEPHRINE 1:200000
Dosage Form : SOLUTION
Dosage Strength : 10MG/ML
Packaging : 20ML
Approval Date :
Application Number : 1805
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : XYLOCAINE 1%
Dosage Form : SOLUTION
Dosage Strength : 10MG/ML
Packaging : 20ML/50ML
Approval Date :
Application Number : 2302411
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : XYLOCAINE 2%
Dosage Form : SOLUTION
Dosage Strength : 20MG/ML
Packaging : 20ML/50ML
Approval Date :
Application Number : 2302438
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : XYLOCAINE 0.5%
Dosage Form : SOLUTION
Dosage Strength : 5MG/ML
Packaging : 20ML
Approval Date :
Application Number : 2372983
Regulatory Info :
Registration Country : Canada
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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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Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
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Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
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ABOUT THIS PAGE
A Lidocaine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lidocaine Hydrochloride, including repackagers and relabelers. The FDA regulates Lidocaine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lidocaine 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 Lidocaine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lidocaine Hydrochloride supplier is an individual or a company that provides Lidocaine Hydrochloride active pharmaceutical ingredient (API) or Lidocaine Hydrochloride finished formulations upon request. The Lidocaine Hydrochloride suppliers may include Lidocaine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Lidocaine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lidocaine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Lidocaine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Lidocaine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Lidocaine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lidocaine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Lidocaine Hydrochloride USDMF includes data on Lidocaine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lidocaine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lidocaine 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 Lidocaine Hydrochloride Drug Master File in Japan (Lidocaine Hydrochloride JDMF) empowers Lidocaine 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 Lidocaine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Lidocaine 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 Lidocaine 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 Lidocaine Hydrochloride Drug Master File in Korea (Lidocaine Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lidocaine Hydrochloride. The MFDS reviews the Lidocaine Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Lidocaine Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Lidocaine 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 Lidocaine Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Lidocaine Hydrochloride suppliers with KDMF on PharmaCompass.
A Lidocaine Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Lidocaine Hydrochloride Certificate of Suitability (COS). The purpose of a Lidocaine Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Lidocaine Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Lidocaine Hydrochloride to their clients by showing that a Lidocaine Hydrochloride CEP has been issued for it. The manufacturer submits a Lidocaine Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Lidocaine Hydrochloride CEP holder for the record. Additionally, the data presented in the Lidocaine Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Lidocaine Hydrochloride DMF.
A Lidocaine Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Lidocaine 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 Lidocaine Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Lidocaine Hydrochloride written confirmation (Lidocaine Hydrochloride WC) is an official document issued by a regulatory agency to a Lidocaine Hydrochloride manufacturer, verifying that the manufacturing facility of a Lidocaine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Lidocaine Hydrochloride APIs or Lidocaine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Lidocaine Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Lidocaine 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 Lidocaine Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Lidocaine 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 Lidocaine 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 Lidocaine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lidocaine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Lidocaine Hydrochloride suppliers with NDC on PharmaCompass.
Lidocaine 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 Lidocaine 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 Lidocaine Hydrochloride GMP manufacturer or Lidocaine Hydrochloride GMP API supplier for your needs.
A Lidocaine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Lidocaine Hydrochloride's compliance with Lidocaine Hydrochloride specifications and serves as a tool for batch-level quality control.
Lidocaine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Lidocaine 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.
Lidocaine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Lidocaine Hydrochloride EP), Lidocaine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lidocaine Hydrochloride USP).
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