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VMF
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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API SUPPLIERS
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USDMF
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DOSAGE - CAPSULE;ORAL - EQ 150MG BASE
USFDA APPLICATION NUMBER - 50162
DOSAGE - CAPSULE;ORAL - EQ 300MG BASE
USFDA APPLICATION NUMBER - 50162
DOSAGE - CAPSULE;ORAL - EQ 75MG BASE
USFDA APPLICATION NUMBER - 50162
Related Excipient Companies
SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
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Direct Compression
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Thickeners and Stabilizers
Co-Processed Excipients
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Chewable & Orodispersible Aids
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Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
ANALYTICAL
Analytical Methods
ABOUT THIS PAGE
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PharmaCompass offers a list of Clindamycin 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 Clindamycin Hydrochloride manufacturer or Clindamycin Hydrochloride supplier for your needs.
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A BenzaClin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of BenzaClin, including repackagers and relabelers. The FDA regulates BenzaClin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. BenzaClin 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 BenzaClin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A BenzaClin supplier is an individual or a company that provides BenzaClin active pharmaceutical ingredient (API) or BenzaClin finished formulations upon request. The BenzaClin suppliers may include BenzaClin API manufacturers, exporters, distributors and traders.
click here to find a list of BenzaClin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A BenzaClin DMF (Drug Master File) is a document detailing the whole manufacturing process of BenzaClin active pharmaceutical ingredient (API) in detail. Different forms of BenzaClin DMFs exist exist since differing nations have different regulations, such as BenzaClin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A BenzaClin DMF submitted to regulatory agencies in the US is known as a USDMF. BenzaClin USDMF includes data on BenzaClin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The BenzaClin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of BenzaClin 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 BenzaClin Drug Master File in Japan (BenzaClin JDMF) empowers BenzaClin 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 BenzaClin JDMF during the approval evaluation for pharmaceutical products. At the time of BenzaClin 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 BenzaClin 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 BenzaClin Drug Master File in Korea (BenzaClin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of BenzaClin. The MFDS reviews the BenzaClin KDMF as part of the drug registration process and uses the information provided in the BenzaClin KDMF to evaluate the safety and efficacy of the drug.
After submitting a BenzaClin 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 BenzaClin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of BenzaClin suppliers with KDMF on PharmaCompass.
A BenzaClin CEP of the European Pharmacopoeia monograph is often referred to as a BenzaClin Certificate of Suitability (COS). The purpose of a BenzaClin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of BenzaClin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of BenzaClin to their clients by showing that a BenzaClin CEP has been issued for it. The manufacturer submits a BenzaClin CEP (COS) as part of the market authorization procedure, and it takes on the role of a BenzaClin CEP holder for the record. Additionally, the data presented in the BenzaClin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the BenzaClin DMF.
A BenzaClin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. BenzaClin 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 BenzaClin suppliers with CEP (COS) on PharmaCompass.
A BenzaClin written confirmation (BenzaClin WC) is an official document issued by a regulatory agency to a BenzaClin manufacturer, verifying that the manufacturing facility of a BenzaClin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting BenzaClin APIs or BenzaClin finished pharmaceutical products to another nation, regulatory agencies frequently require a BenzaClin WC (written confirmation) as part of the regulatory process.
click here to find a list of BenzaClin 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 BenzaClin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for BenzaClin 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 BenzaClin 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 BenzaClin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a BenzaClin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of BenzaClin suppliers with NDC on PharmaCompass.
BenzaClin 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 BenzaClin 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 BenzaClin GMP manufacturer or BenzaClin GMP API supplier for your needs.
A BenzaClin CoA (Certificate of Analysis) is a formal document that attests to BenzaClin's compliance with BenzaClin specifications and serves as a tool for batch-level quality control.
BenzaClin CoA mostly includes findings from lab analyses of a specific batch. For each BenzaClin 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.
BenzaClin may be tested according to a variety of international standards, such as European Pharmacopoeia (BenzaClin EP), BenzaClin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (BenzaClin USP).
