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DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 2%
USFDA APPLICATION NUMBER - 84108
DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 0.5%
USFDA APPLICATION NUMBER - 84109
DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 1%
USFDA APPLICATION NUMBER - 84110
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Cyclopentolate Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cyclopentolate Hydrochloride, including repackagers and relabelers. The FDA regulates Cyclopentolate Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cyclopentolate Hydrochloride 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 Cyclopentolate Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cyclopentolate Hydrochloride supplier is an individual or a company that provides Cyclopentolate Hydrochloride active pharmaceutical ingredient (API) or Cyclopentolate Hydrochloride finished formulations upon request. The Cyclopentolate Hydrochloride suppliers may include Cyclopentolate Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Cyclopentolate Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cyclopentolate Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Cyclopentolate Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Cyclopentolate Hydrochloride DMFs exist exist since differing nations have different regulations, such as Cyclopentolate Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cyclopentolate Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Cyclopentolate Hydrochloride USDMF includes data on Cyclopentolate Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cyclopentolate Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cyclopentolate Hydrochloride 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 Cyclopentolate Hydrochloride Drug Master File in Japan (Cyclopentolate Hydrochloride JDMF) empowers Cyclopentolate Hydrochloride 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 Cyclopentolate Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Cyclopentolate Hydrochloride 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 Cyclopentolate Hydrochloride suppliers with JDMF on PharmaCompass.
A Cyclopentolate Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Cyclopentolate Hydrochloride Certificate of Suitability (COS). The purpose of a Cyclopentolate Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cyclopentolate Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cyclopentolate Hydrochloride to their clients by showing that a Cyclopentolate Hydrochloride CEP has been issued for it. The manufacturer submits a Cyclopentolate Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cyclopentolate Hydrochloride CEP holder for the record. Additionally, the data presented in the Cyclopentolate Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cyclopentolate Hydrochloride DMF.
A Cyclopentolate Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cyclopentolate Hydrochloride 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 Cyclopentolate Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Cyclopentolate Hydrochloride written confirmation (Cyclopentolate Hydrochloride WC) is an official document issued by a regulatory agency to a Cyclopentolate Hydrochloride manufacturer, verifying that the manufacturing facility of a Cyclopentolate Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cyclopentolate Hydrochloride APIs or Cyclopentolate Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Cyclopentolate Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Cyclopentolate Hydrochloride 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 Cyclopentolate Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cyclopentolate Hydrochloride 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 Cyclopentolate Hydrochloride 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 Cyclopentolate Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cyclopentolate Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cyclopentolate Hydrochloride suppliers with NDC on PharmaCompass.
Cyclopentolate Hydrochloride 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 Cyclopentolate Hydrochloride 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 Cyclopentolate Hydrochloride GMP manufacturer or Cyclopentolate Hydrochloride GMP API supplier for your needs.
A Cyclopentolate Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Cyclopentolate Hydrochloride's compliance with Cyclopentolate Hydrochloride specifications and serves as a tool for batch-level quality control.
Cyclopentolate Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Cyclopentolate Hydrochloride 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.
Cyclopentolate Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Cyclopentolate Hydrochloride EP), Cyclopentolate Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cyclopentolate Hydrochloride USP).
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