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API SUPPLIERS
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USDMF
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DOSAGE - SOLUTION;INTRAVENOUS - EQ 300MG BASE...DOSAGE - SOLUTION;INTRAVENOUS - EQ 300MG BASE/50ML (EQ 6MG BASE/ML)
USFDA APPLICATION NUMBER - 208083
DOSAGE - SOLUTION;INTRAVENOUS - EQ 600MG BASE...DOSAGE - SOLUTION;INTRAVENOUS - EQ 600MG BASE/50ML (EQ 12MG BASE/ML)
USFDA APPLICATION NUMBER - 208083
DOSAGE - SOLUTION;INTRAVENOUS - EQ 900MG BASE...DOSAGE - SOLUTION;INTRAVENOUS - EQ 900MG BASE/50ML (EQ 18MG BASE/ML)
USFDA APPLICATION NUMBER - 208083
DOSAGE - INJECTABLE;INJECTION - EQ 150MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 150MG BASE/ML
USFDA APPLICATION NUMBER - 50441
DOSAGE - SOLUTION;TOPICAL - EQ 1% BASE **Fede...DOSAGE - SOLUTION;TOPICAL - EQ 1% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50537
DOSAGE - LOTION;TOPICAL - EQ 1% BASE
USFDA APPLICATION NUMBER - 50600
DOSAGE - GEL;TOPICAL - EQ 1% BASE
USFDA APPLICATION NUMBER - 50615
DOSAGE - GEL;TOPICAL - 5%;1.2%
USFDA APPLICATION NUMBER - 50741
DOSAGE - GEL;TOPICAL - 5%;EQ 1% BASE
USFDA APPLICATION NUMBER - 50756
DOSAGE - SUPPOSITORY;VAGINAL - 100MG
USFDA APPLICATION NUMBER - 50767
DOSAGE - GEL;TOPICAL - EQ 1% BASE
USFDA APPLICATION NUMBER - 50782
DOSAGE - CREAM;VAGINAL - EQ 2% BASE
USFDA APPLICATION NUMBER - 50793
DOSAGE - AEROSOL, FOAM;TOPICAL - 1% **Federal...DOSAGE - AEROSOL, FOAM;TOPICAL - 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50801
DOSAGE - GEL;TOPICAL - 1.2%;0.025%
USFDA APPLICATION NUMBER - 50803
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EUROAPI
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ABOUT THIS PAGE
54
PharmaCompass offers a list of Clindamycin Phosphate 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 Clindamycin Phosphate manufacturer or Clindamycin Phosphate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Clindamycin Phosphate manufacturer or Clindamycin Phosphate supplier.
A Clindagel manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Clindagel, including repackagers and relabelers. The FDA regulates Clindagel manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Clindagel 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 Clindagel manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Clindagel supplier is an individual or a company that provides Clindagel active pharmaceutical ingredient (API) or Clindagel finished formulations upon request. The Clindagel suppliers may include Clindagel API manufacturers, exporters, distributors and traders.
click here to find a list of Clindagel suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Clindagel DMF (Drug Master File) is a document detailing the whole manufacturing process of Clindagel active pharmaceutical ingredient (API) in detail. Different forms of Clindagel DMFs exist exist since differing nations have different regulations, such as Clindagel USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Clindagel DMF submitted to regulatory agencies in the US is known as a USDMF. Clindagel USDMF includes data on Clindagel's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Clindagel USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Clindagel 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 Clindagel Drug Master File in Japan (Clindagel JDMF) empowers Clindagel 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 Clindagel JDMF during the approval evaluation for pharmaceutical products. At the time of Clindagel 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 Clindagel 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 Clindagel Drug Master File in Korea (Clindagel KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Clindagel. The MFDS reviews the Clindagel KDMF as part of the drug registration process and uses the information provided in the Clindagel KDMF to evaluate the safety and efficacy of the drug.
After submitting a Clindagel 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 Clindagel API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Clindagel suppliers with KDMF on PharmaCompass.
A Clindagel CEP of the European Pharmacopoeia monograph is often referred to as a Clindagel Certificate of Suitability (COS). The purpose of a Clindagel CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Clindagel EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Clindagel to their clients by showing that a Clindagel CEP has been issued for it. The manufacturer submits a Clindagel CEP (COS) as part of the market authorization procedure, and it takes on the role of a Clindagel CEP holder for the record. Additionally, the data presented in the Clindagel CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Clindagel DMF.
A Clindagel CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Clindagel 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 Clindagel suppliers with CEP (COS) on PharmaCompass.
A Clindagel written confirmation (Clindagel WC) is an official document issued by a regulatory agency to a Clindagel manufacturer, verifying that the manufacturing facility of a Clindagel active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Clindagel APIs or Clindagel finished pharmaceutical products to another nation, regulatory agencies frequently require a Clindagel WC (written confirmation) as part of the regulatory process.
click here to find a list of Clindagel 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 Clindagel as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Clindagel 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 Clindagel 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 Clindagel and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Clindagel NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Clindagel suppliers with NDC on PharmaCompass.
Clindagel 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 Clindagel GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Clindagel GMP manufacturer or Clindagel GMP API supplier for your needs.
A Clindagel CoA (Certificate of Analysis) is a formal document that attests to Clindagel's compliance with Clindagel specifications and serves as a tool for batch-level quality control.
Clindagel CoA mostly includes findings from lab analyses of a specific batch. For each Clindagel 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.
Clindagel may be tested according to a variety of international standards, such as European Pharmacopoeia (Clindagel EP), Clindagel JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Clindagel USP).
