Close
4

Athena Athena

X

Find Terfenadine manufacturers, exporters & distributors on PharmaCompass

PharmaCompass
API SUPPLIERS
API Suppliers

API Suppliers

US DMFs Filed

US DMFs Filed

CEP/COS Certifications

CEP/COS Certifications

JDMFs Filed

JDMFs Filed

0

Other Certificates

Other Certificates

0

Other Suppliers

Other Suppliers

0

API REF. PRICE (USD / KG)

0

INTERMEDIATES
DOSSIERS // FDF
USA (Orange Book)

USA (Orange Book)

0

Europe

Europe

0

Canada

Canada

0

Australia

Australia

0

South Africa

South Africa

0

Uploaded Dossiers

Uploaded Dossiers

GLOBAL SALES (USD Million)

U.S. Medicaid

0

Annual Reports

0

EXCIPIENTS

0

PATENTS & EXCLUSIVITIES

USFDA Orange Book Patents

0

USFDA Exclusivities

0

DIGITAL CONTENT

Blog #PharmaFlow

0

News

REF STANDARD

EDQM

USP

JP

0

Other Listed Suppliers

0

SERVICES

0

Looking for 50679-08-8 / Terfenadine API manufacturers, exporters & distributors?

Terfenadine manufacturers, exporters & distributors 1

62

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

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

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

API | Excipient name

Terfenadine

Synonyms

50679-08-8, Seldane, Ternadin, Triludan, Teldane, Allerplus

Cas Number

50679-08-8

Unique Ingredient Identifier (UNII)

7BA5G9Y06Q

About Terfenadine

A selective histamine H1-receptor antagonist devoid of central nervous system depressant activity. The drug was used for ALLERGY but withdrawn due to causing LONG QT SYNDROME.

Terfenadine Manufacturers

A Terfenadine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Terfenadine, including repackagers and relabelers. The FDA regulates Terfenadine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Terfenadine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

Terfenadine Suppliers

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

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

Terfenadine USDMF

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

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

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

Terfenadine CEP

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

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

Terfenadine GMP

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

Terfenadine CoA

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

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

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