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  • TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Looking for 73963-72-1 / Cilostazol API manufacturers, exporters & distributors?

Cilostazol manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Cilostazol 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 Cilostazol manufacturer or Cilostazol supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cilostazol manufacturer or Cilostazol supplier.

PharmaCompass also assists you with knowing the Cilostazol API Price utilized in the formulation of products. Cilostazol API Price is not always fixed or binding as the Cilostazol Price is obtained through a variety of data sources. The Cilostazol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Cilostazol

Synonyms

73963-72-1, Pletal, Cilostazole, Pletaal, Opc-13013, Cilostazolum

Cas Number

73963-72-1

Unique Ingredient Identifier (UNII)

N7Z035406B

About Cilostazol

A quinoline and tetrazole derivative that acts as a phosphodiesterase type 3 inhibitor, with anti-platelet and vasodilating activity. It is used in the treatment of PERIPHERAL VASCULAR DISEASES; ISCHEMIC HEART DISEASE; and in the prevention of stroke.

Cilostazol Manufacturers

A Cilostazol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cilostazol, including repackagers and relabelers. The FDA regulates Cilostazol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cilostazol 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 Cilostazol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Cilostazol Suppliers

A Cilostazol supplier is an individual or a company that provides Cilostazol active pharmaceutical ingredient (API) or Cilostazol finished formulations upon request. The Cilostazol suppliers may include Cilostazol API manufacturers, exporters, distributors and traders.

click here to find a list of Cilostazol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Cilostazol USDMF

A Cilostazol DMF (Drug Master File) is a document detailing the whole manufacturing process of Cilostazol active pharmaceutical ingredient (API) in detail. Different forms of Cilostazol DMFs exist exist since differing nations have different regulations, such as Cilostazol USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Cilostazol DMF submitted to regulatory agencies in the US is known as a USDMF. Cilostazol USDMF includes data on Cilostazol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cilostazol USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Cilostazol suppliers with USDMF on PharmaCompass.

Cilostazol JDMF

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 Cilostazol Drug Master File in Japan (Cilostazol JDMF) empowers Cilostazol 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 Cilostazol JDMF during the approval evaluation for pharmaceutical products. At the time of Cilostazol 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 Cilostazol suppliers with JDMF on PharmaCompass.

Cilostazol KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Cilostazol Drug Master File in Korea (Cilostazol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cilostazol. The MFDS reviews the Cilostazol KDMF as part of the drug registration process and uses the information provided in the Cilostazol KDMF to evaluate the safety and efficacy of the drug.

After submitting a Cilostazol 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 Cilostazol API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Cilostazol suppliers with KDMF on PharmaCompass.

Cilostazol WC

A Cilostazol written confirmation (Cilostazol WC) is an official document issued by a regulatory agency to a Cilostazol manufacturer, verifying that the manufacturing facility of a Cilostazol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cilostazol APIs or Cilostazol finished pharmaceutical products to another nation, regulatory agencies frequently require a Cilostazol WC (written confirmation) as part of the regulatory process.

click here to find a list of Cilostazol suppliers with Written Confirmation (WC) on PharmaCompass.

Cilostazol NDC

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 Cilostazol as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Cilostazol API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Cilostazol 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Cilostazol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cilostazol NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Cilostazol suppliers with NDC on PharmaCompass.

Cilostazol GMP

Cilostazol 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 Cilostazol 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 Cilostazol GMP manufacturer or Cilostazol GMP API supplier for your needs.

Cilostazol CoA

A Cilostazol CoA (Certificate of Analysis) is a formal document that attests to Cilostazol's compliance with Cilostazol specifications and serves as a tool for batch-level quality control.

Cilostazol CoA mostly includes findings from lab analyses of a specific batch. For each Cilostazol 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.

Cilostazol may be tested according to a variety of international standards, such as European Pharmacopoeia (Cilostazol EP), Cilostazol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cilostazol USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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