MolPort-001-759-081

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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.

MolPort-001-759-081 Manufacturers

A MolPort-001-759-081 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of MolPort-001-759-081, including repackagers and relabelers. The FDA regulates MolPort-001-759-081 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. MolPort-001-759-081 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 MolPort-001-759-081 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

MolPort-001-759-081 Suppliers

A MolPort-001-759-081 supplier is an individual or a company that provides MolPort-001-759-081 active pharmaceutical ingredient (API) or MolPort-001-759-081 finished formulations upon request. The MolPort-001-759-081 suppliers may include MolPort-001-759-081 API manufacturers, exporters, distributors and traders.

click here to find a list of MolPort-001-759-081 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

MolPort-001-759-081 KDMF

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

Pharmaceutical companies submit a MolPort-001-759-081 Drug Master File in Korea (MolPort-001-759-081 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of MolPort-001-759-081. The MFDS reviews the MolPort-001-759-081 KDMF as part of the drug registration process and uses the information provided in the MolPort-001-759-081 KDMF to evaluate the safety and efficacy of the drug.

After submitting a MolPort-001-759-081 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 MolPort-001-759-081 API can apply through the Korea Drug Master File (KDMF).

click here to find a list of MolPort-001-759-081 suppliers with KDMF on PharmaCompass.

MolPort-001-759-081 Manufacturers | Traders | Suppliers

We have 26 companies offering MolPort-001-759-081

Get in contact with the supplier of your choice:

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.

List of Drug Master Files (KDMF) for MolPort-001-759-081 Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

Synopsis

Chemistry

APIs // Active Pharmaceutical Ingredients

107 Suppliers

41 USDMF

42 CEP/COS

25 JDMF

27 EU WC

78 KDMF

25 NDC API

49 Listed Suppliers

DEVELOPMENTS

3 Drug(s) in Development

PRICE INFORMATION

API Reference Price

API Exports

API Imports

FDF Exports

FDF Imports

INTERMEDIATES

11 Suppliers

DOSSIERs // Finished Dosage Forms

842 Dossiers

420 FDA Orange Book

111 Europe

134 Canada

13 Australia

35 South Africa

129 Listed Dossiers

DRUG PRODUCT COMPOSITION

TABLET;ORAL - EQ 10MG BASE

TABLET;ORAL - EQ 2.5MG BASE

TABLET;ORAL - EQ 5MG BASE

CAPSULE;ORAL - EQ 10MG BASE;20MG

CAPSULE;ORAL - EQ 10MG BASE;40MG

CAPSULE;ORAL - EQ 2.5MG BASE;10MG

CAPSULE;ORAL - EQ 5MG BASE;10MG

CAPSULE;ORAL - EQ 5MG BASE;20MG

CAPSULE;ORAL - EQ 5MG BASE;40MG

TABLET;ORAL - EQ 10MG BASE;14MG

TABLET;ORAL - EQ 2.5MG BASE;3.5MG

TABLET;ORAL - EQ 5MG BASE;7MG

TABLET;ORAL - EQ 10MG BASE;200MG

TABLET;ORAL - EQ 2.5MG BASE;200MG

TABLET;ORAL - EQ 5MG BASE;200MG

TABLET;ORAL - EQ 10MG BASE;EQ 10MG BASE

TABLET;ORAL - EQ 10MG BASE;EQ 20MG BASE

TABLET;ORAL - EQ 10MG BASE;EQ 40MG BASE

TABLET;ORAL - EQ 10MG BASE;EQ 80MG BASE

TABLET;ORAL - EQ 2.5MG BASE;EQ 10MG BASE

TABLET;ORAL - EQ 2.5MG BASE;EQ 20MG BASE

TABLET;ORAL - EQ 2.5MG BASE;EQ 40MG BASE

TABLET;ORAL - EQ 5MG BASE;EQ 10MG BASE

TABLET;ORAL - EQ 5MG BASE;EQ 20MG BASE

TABLET;ORAL - EQ 5MG BASE;EQ 40MG BASE

TABLET;ORAL - EQ 5MG BASE;EQ 80MG BASE

TABLET;ORAL - EQ 10MG BASE;160MG

TABLET;ORAL - EQ 10MG BASE;320MG

TABLET;ORAL - EQ 5MG BASE;160MG

TABLET;ORAL - EQ 5MG BASE;320MG

TABLET;ORAL - EQ 10MG BASE;20MG

TABLET;ORAL - EQ 10MG BASE;40MG

TABLET;ORAL - EQ 5MG BASE;20MG

TABLET;ORAL - EQ 5MG BASE;40MG

TABLET;ORAL - EQ 10MG BASE;12.5MG;160MG

TABLET;ORAL - EQ 10MG BASE;25MG;160MG

TABLET;ORAL - EQ 10MG BASE;25MG;320MG

TABLET;ORAL - EQ 5MG BASE;12.5MG;160MG

TABLET;ORAL - EQ 5MG BASE;25MG;160MG

TABLET;ORAL - EQ 10MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 10MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 5MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 5MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

Suppliers

39 Kerry

35 BASF

23 Roquette

TABLET;ORAL - EQ 10MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 10MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 5MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 5MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons