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