Close
4

AbbVie Contract Manufacturing AbbVie Contract Manufacturing

X

Find Alogliptin Benzoate manufacturers, exporters & distributors on PharmaCompass

PharmaCompass
API SUPPLIERS
API Suppliers

API Suppliers

US DMFs Filed

US DMFs Filed

CEP/COS Certifications

CEP/COS Certifications

0

JDMFs Filed

JDMFs Filed

EU WC

EU WC

Listed Suppliers

Listed Suppliers

API REF. PRICE (USD / KG)
INTERMEDIATES
DOSSIERS // FDF
USA (Orange Book)

USA (Orange Book)

Europe

Europe

Canada

Canada

Australia

Australia

South Africa

South Africa

0

Uploaded Dossiers

Uploaded Dossiers

GLOBAL SALES (USD Million)

U.S. Medicaid

Annual Reports

EXCIPIENTS
PATENTS & EXCLUSIVITIES

USFDA Orange Book Patents

USFDA Exclusivities

DIGITAL CONTENT

Blog #PharmaFlow

News

REF STANDARD

EDQM

0

USP

0

JP

0

Other Listed Suppliers

SERVICES

0

left grey arrow
right gray arrow
  • TABLET;ORAL - EQ 12.5MG BASE;1GM
  • TABLET;ORAL - EQ 12.5MG BASE;500MG
  • TABLET;ORAL - EQ 12.5MG BASE
  • TABLET;ORAL - EQ 25MG BASE
  • TABLET;ORAL - EQ 6.25MG BASE

Looking for 850649-62-6 / Alogliptin Benzoate API manufacturers, exporters & distributors?

Alogliptin Benzoate manufacturers, exporters & distributors 1

63

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

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

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

API | Excipient name

Alogliptin Benzoate

Synonyms

850649-62-6, Nesina, Syr 322, Syr-322, Alogliptin (benzoate), (r)-2-((6-(3-aminopiperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2h)-yl)methyl)benzonitrile benzoate

Cas Number

850649-62-6

Unique Ingredient Identifier (UNII)

EEN99869SC

About Alogliptin Benzoate

Alogliptin Benzoate is the benzoate salt form of alogliptin, a selective, orally bioavailable, pyrimidinedione-based inhibitor of dipeptidyl peptidase 4 (DPP-4), with hypoglycemic activity. In addition to its effect on glucose levels, alogliptin may inhibit inflammatory responses by preventing the toll-like receptor 4 (TLR-4)-mediated formation of proinflammatory cytokines.

Alogliptin Benzoate Manufacturers

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

Alogliptin Benzoate Suppliers

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

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

Alogliptin Benzoate USDMF

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

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

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

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

Alogliptin Benzoate KDMF

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

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

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

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

Alogliptin Benzoate WC

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

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

Alogliptin Benzoate 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 Alogliptin Benzoate as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Alogliptin Benzoate GMP

Alogliptin Benzoate 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 Alogliptin Benzoate 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 Alogliptin Benzoate GMP manufacturer or Alogliptin Benzoate GMP API supplier for your needs.

Alogliptin Benzoate CoA

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

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

Alogliptin Benzoate may be tested according to a variety of international standards, such as European Pharmacopoeia (Alogliptin Benzoate EP), Alogliptin Benzoate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Alogliptin Benzoate 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.
Ask Us for Pharmaceutical Supplier and Partner
Ask Us, Find A Supplier / Partner
No Commissions, No Strings Attached, Get Connected for FREE

What are you looking for?

How can we help you?

The request can't be empty

Please read our Privacy Policy carefully

You must agree to the privacy policy

The name can't be empty
The company can't be empty.
The email can't be empty Please enter a valid email.
The mobile can't be empty
Post Enquiry
POST ENQUIRY