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BioXera Pharma: A trusted partner for high-quality human and veterinary APIs and intermediates across global regulated markets.
Cyclopentolate Hydrochloride BP/EP/USP
Date of Issue : 2025-12-02
Valid Till : 2028-12-01
Written Confirmation Number : WC-0248
Address of the Firm : Plot No. N-57, Anand Nagar, Additional M.I.D.C., Ambernath (East)-421506, Mahara...
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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
DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 0.2%;1%
USFDA APPLICATION NUMBER - 84300
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Kirsch Pharma
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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 Zyklolat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zyklolat, including repackagers and relabelers. The FDA regulates Zyklolat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zyklolat 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 Zyklolat manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Zyklolat supplier is an individual or a company that provides Zyklolat active pharmaceutical ingredient (API) or Zyklolat finished formulations upon request. The Zyklolat suppliers may include Zyklolat API manufacturers, exporters, distributors and traders.
click here to find a list of Zyklolat suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Zyklolat DMF (Drug Master File) is a document detailing the whole manufacturing process of Zyklolat active pharmaceutical ingredient (API) in detail. Different forms of Zyklolat DMFs exist exist since differing nations have different regulations, such as Zyklolat USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Zyklolat DMF submitted to regulatory agencies in the US is known as a USDMF. Zyklolat USDMF includes data on Zyklolat's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Zyklolat USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Zyklolat 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 Zyklolat Drug Master File in Japan (Zyklolat JDMF) empowers Zyklolat 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 Zyklolat JDMF during the approval evaluation for pharmaceutical products. At the time of Zyklolat 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 Zyklolat 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 Zyklolat Drug Master File in Korea (Zyklolat KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Zyklolat. The MFDS reviews the Zyklolat KDMF as part of the drug registration process and uses the information provided in the Zyklolat KDMF to evaluate the safety and efficacy of the drug.
After submitting a Zyklolat 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 Zyklolat API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Zyklolat suppliers with KDMF on PharmaCompass.
A Zyklolat CEP of the European Pharmacopoeia monograph is often referred to as a Zyklolat Certificate of Suitability (COS). The purpose of a Zyklolat CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Zyklolat EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Zyklolat to their clients by showing that a Zyklolat CEP has been issued for it. The manufacturer submits a Zyklolat CEP (COS) as part of the market authorization procedure, and it takes on the role of a Zyklolat CEP holder for the record. Additionally, the data presented in the Zyklolat CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Zyklolat DMF.
A Zyklolat CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Zyklolat 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 Zyklolat suppliers with CEP (COS) on PharmaCompass.
A Zyklolat written confirmation (Zyklolat WC) is an official document issued by a regulatory agency to a Zyklolat manufacturer, verifying that the manufacturing facility of a Zyklolat active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Zyklolat APIs or Zyklolat finished pharmaceutical products to another nation, regulatory agencies frequently require a Zyklolat WC (written confirmation) as part of the regulatory process.
click here to find a list of Zyklolat 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 Zyklolat as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Zyklolat 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 Zyklolat 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 Zyklolat and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Zyklolat NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Zyklolat suppliers with NDC on PharmaCompass.
Zyklolat 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 Zyklolat 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 Zyklolat GMP manufacturer or Zyklolat GMP API supplier for your needs.
A Zyklolat CoA (Certificate of Analysis) is a formal document that attests to Zyklolat's compliance with Zyklolat specifications and serves as a tool for batch-level quality control.
Zyklolat CoA mostly includes findings from lab analyses of a specific batch. For each Zyklolat 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.
Zyklolat may be tested according to a variety of international standards, such as European Pharmacopoeia (Zyklolat EP), Zyklolat JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Zyklolat USP).
