Synopsis
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VMF
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Australia
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
Chynops Pharma is an ideal sourcing partner for high-quality APIs, advanced intermediates, speciality chemicals & excipients.
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.
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Atman Pharma Private Limited: A One Stop Solution Provider to All Your API Needs.
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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
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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**Federal ...DOSAGE - INJECTABLE;INJECTION - 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**Federal ...DOSAGE - INJECTABLE;INJECTION - 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**Federal...DOSAGE - INJECTABLE;INJECTION - 20% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**Federal ...DOSAGE - INJECTABLE;INJECTION - 4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
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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 Xylocaine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Xylocaine, including repackagers and relabelers. The FDA regulates Xylocaine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Xylocaine 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 Xylocaine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Xylocaine supplier is an individual or a company that provides Xylocaine active pharmaceutical ingredient (API) or Xylocaine finished formulations upon request. The Xylocaine suppliers may include Xylocaine API manufacturers, exporters, distributors and traders.
click here to find a list of Xylocaine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Xylocaine DMF (Drug Master File) is a document detailing the whole manufacturing process of Xylocaine active pharmaceutical ingredient (API) in detail. Different forms of Xylocaine DMFs exist exist since differing nations have different regulations, such as Xylocaine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Xylocaine DMF submitted to regulatory agencies in the US is known as a USDMF. Xylocaine USDMF includes data on Xylocaine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Xylocaine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Xylocaine 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 Xylocaine Drug Master File in Japan (Xylocaine JDMF) empowers Xylocaine 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 Xylocaine JDMF during the approval evaluation for pharmaceutical products. At the time of Xylocaine 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 Xylocaine 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 Xylocaine Drug Master File in Korea (Xylocaine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Xylocaine. The MFDS reviews the Xylocaine KDMF as part of the drug registration process and uses the information provided in the Xylocaine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Xylocaine 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 Xylocaine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Xylocaine suppliers with KDMF on PharmaCompass.
A Xylocaine CEP of the European Pharmacopoeia monograph is often referred to as a Xylocaine Certificate of Suitability (COS). The purpose of a Xylocaine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Xylocaine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Xylocaine to their clients by showing that a Xylocaine CEP has been issued for it. The manufacturer submits a Xylocaine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Xylocaine CEP holder for the record. Additionally, the data presented in the Xylocaine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Xylocaine DMF.
A Xylocaine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Xylocaine 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 Xylocaine suppliers with CEP (COS) on PharmaCompass.
A Xylocaine written confirmation (Xylocaine WC) is an official document issued by a regulatory agency to a Xylocaine manufacturer, verifying that the manufacturing facility of a Xylocaine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Xylocaine APIs or Xylocaine finished pharmaceutical products to another nation, regulatory agencies frequently require a Xylocaine WC (written confirmation) as part of the regulatory process.
click here to find a list of Xylocaine 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 Xylocaine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Xylocaine 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 Xylocaine 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 Xylocaine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Xylocaine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Xylocaine suppliers with NDC on PharmaCompass.
Xylocaine 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 Xylocaine 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 Xylocaine GMP manufacturer or Xylocaine GMP API supplier for your needs.
A Xylocaine CoA (Certificate of Analysis) is a formal document that attests to Xylocaine's compliance with Xylocaine specifications and serves as a tool for batch-level quality control.
Xylocaine CoA mostly includes findings from lab analyses of a specific batch. For each Xylocaine 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.
Xylocaine may be tested according to a variety of international standards, such as European Pharmacopoeia (Xylocaine EP), Xylocaine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Xylocaine USP).
