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Polpharma European CDMO Partner & API Manufacturer since 1951 Polpharma European CDMO Partner & API Manufacturer since 1951

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  • TABLET;ORAL - EQ 10MG BASE
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  • TABLET;ORAL - EQ 2.5MG BASE;EQ 10MG BASE
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  • TABLET;ORAL - EQ 2.5MG BASE;EQ 40MG BASE
  • TABLET;ORAL - EQ 5MG BASE;EQ 10MG BASE
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Looking for 111470-99-6 / Amlodipine Besylate API manufacturers, exporters & distributors?

Amlodipine Besylate manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Amlodipine Besylate

Synonyms

111470-99-6, Amlodipine besilate, Amlodipine benzenesulfonate, Antacal, Monopina, Istin

Cas Number

111470-99-6

Unique Ingredient Identifier (UNII)

864V2Q084H

About Amlodipine Besylate

A long-acting dihydropyridine calcium channel blocker. It is effective in the treatment of ANGINA PECTORIS and HYPERTENSION.

Amlodipine Besylate Manufacturers

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

Amlodipine Besylate Suppliers

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

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

Amlodipine Besylate USDMF

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

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

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

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

Amlodipine Besylate KDMF

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

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

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

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

Amlodipine Besylate CEP

A Amlodipine Besylate CEP of the European Pharmacopoeia monograph is often referred to as a Amlodipine Besylate Certificate of Suitability (COS). The purpose of a Amlodipine Besylate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Amlodipine Besylate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Amlodipine Besylate to their clients by showing that a Amlodipine Besylate CEP has been issued for it. The manufacturer submits a Amlodipine Besylate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Amlodipine Besylate CEP holder for the record. Additionally, the data presented in the Amlodipine Besylate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Amlodipine Besylate DMF.

A Amlodipine Besylate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Amlodipine Besylate 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 Amlodipine Besylate suppliers with CEP (COS) on PharmaCompass.

Amlodipine Besylate WC

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

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

Amlodipine Besylate NDC