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**Federal ...DOSAGE - INJECTABLE;INJECTION - 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**Federal ...DOSAGE - INJECTABLE;INJECTION - 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**Federal...DOSAGE - INJECTABLE;INJECTION - 20% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**Federal ...DOSAGE - INJECTABLE;INJECTION - 4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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