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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
SWATI - Transforming science into solutions with 60+ years of expertise, global accreditations, and pioneering biotech innovation.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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.
China’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
Apex Healthcare Limited: ISO 9001:2008, WHO-GMP, US FDA-audited manufacturer & exporter of APIs, bulk drugs, and formulations.
CEP/COS 
EU-WC
NDC
Together we can improve the quality of life
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
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USDMF
SWATI - Transforming science into solutions with 60+ years of expertise, global accreditations, and pioneering biotech innovation.
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-05
Pay. Date : 2013-09-18
DMF Number : 25963
Submission : 2012-03-06
Status :
Type : II
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**Federal ...DOSAGE - INJECTABLE;INJECTION - 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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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REF. STANDARDS & IMPURITIES
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, 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.
A Lidocaine Carbonate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lidocaine Carbonate, including repackagers and relabelers. The FDA regulates Lidocaine Carbonate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lidocaine Carbonate 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 Carbonate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Lidocaine Carbonate supplier is an individual or a company that provides Lidocaine Carbonate active pharmaceutical ingredient (API) or Lidocaine Carbonate finished formulations upon request. The Lidocaine Carbonate suppliers may include Lidocaine Carbonate API manufacturers, exporters, distributors and traders.
click here to find a list of Lidocaine Carbonate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Lidocaine Carbonate DMF (Drug Master File) is a document detailing the whole manufacturing process of Lidocaine Carbonate active pharmaceutical ingredient (API) in detail. Different forms of Lidocaine Carbonate DMFs exist exist since differing nations have different regulations, such as Lidocaine Carbonate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lidocaine Carbonate DMF submitted to regulatory agencies in the US is known as a USDMF. Lidocaine Carbonate USDMF includes data on Lidocaine Carbonate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lidocaine Carbonate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lidocaine Carbonate 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 Carbonate Drug Master File in Japan (Lidocaine Carbonate JDMF) empowers Lidocaine Carbonate 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 Carbonate JDMF during the approval evaluation for pharmaceutical products. At the time of Lidocaine Carbonate 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 Carbonate 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 Carbonate Drug Master File in Korea (Lidocaine Carbonate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lidocaine Carbonate. The MFDS reviews the Lidocaine Carbonate KDMF as part of the drug registration process and uses the information provided in the Lidocaine Carbonate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Lidocaine Carbonate 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 Carbonate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Lidocaine Carbonate suppliers with KDMF on PharmaCompass.
A Lidocaine Carbonate CEP of the European Pharmacopoeia monograph is often referred to as a Lidocaine Carbonate Certificate of Suitability (COS). The purpose of a Lidocaine Carbonate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Lidocaine Carbonate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Lidocaine Carbonate to their clients by showing that a Lidocaine Carbonate CEP has been issued for it. The manufacturer submits a Lidocaine Carbonate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Lidocaine Carbonate CEP holder for the record. Additionally, the data presented in the Lidocaine Carbonate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Lidocaine Carbonate DMF.
A Lidocaine Carbonate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Lidocaine Carbonate 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 Carbonate suppliers with CEP (COS) on PharmaCompass.
A Lidocaine Carbonate written confirmation (Lidocaine Carbonate WC) is an official document issued by a regulatory agency to a Lidocaine Carbonate manufacturer, verifying that the manufacturing facility of a Lidocaine Carbonate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Lidocaine Carbonate APIs or Lidocaine Carbonate finished pharmaceutical products to another nation, regulatory agencies frequently require a Lidocaine Carbonate WC (written confirmation) as part of the regulatory process.
click here to find a list of Lidocaine Carbonate 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 Carbonate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Lidocaine Carbonate 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 Carbonate 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 Carbonate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lidocaine Carbonate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Lidocaine Carbonate suppliers with NDC on PharmaCompass.
Lidocaine Carbonate 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 Carbonate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Lidocaine Carbonate GMP manufacturer or Lidocaine Carbonate GMP API supplier for your needs.
A Lidocaine Carbonate CoA (Certificate of Analysis) is a formal document that attests to Lidocaine Carbonate's compliance with Lidocaine Carbonate specifications and serves as a tool for batch-level quality control.
Lidocaine Carbonate CoA mostly includes findings from lab analyses of a specific batch. For each Lidocaine Carbonate 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 Carbonate may be tested according to a variety of international standards, such as European Pharmacopoeia (Lidocaine Carbonate EP), Lidocaine Carbonate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lidocaine Carbonate USP).
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