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Looking for 87333-19-5 / Ramipril API manufacturers, exporters & distributors?

Ramipril manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Ramipril

Synonyms

87333-19-5, Tritace, Altace, Ramace, Triatec, Delix

Cas Number

87333-19-5

Unique Ingredient Identifier (UNII)

L35JN3I7SJ

About Ramipril

A long-acting angiotensin-converting enzyme inhibitor. It is a prodrug that is transformed in the liver to its active metabolite ramiprilat.

Altace Manufacturers

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

Altace Suppliers

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

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

Altace USDMF

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

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

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

Altace KDMF

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

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

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

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

Altace CEP

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

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

Altace WC

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

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

Altace 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 Altace as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Altace 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 Altace 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 Altace and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Altace NDC to their finished compounded human drug products, they may choose to do so.

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

Altace GMP

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

Altace CoA

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

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

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