Close
4

Athena Athena

X

Find Benzonatate 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

0

Other Certificates

Other Certificates

0

Other Suppliers

Other Suppliers

API REF. PRICE (USD / KG)
109
INTERMEDIATES

0

DOSSIERS // FDF
USA (Orange Book)

USA (Orange Book)

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

Annual Reports

0

EXCIPIENTS
PATENTS & EXCLUSIVITIES

USFDA Orange Book Patents

0

USFDA Exclusivities

0

DIGITAL CONTENT

Blog #PharmaFlow

0

News

REF STANDARD

EDQM

0

USP

JP

0

Other Listed Suppliers

SERVICES
left grey arrow
right gray arrow
  • CAPSULE;ORAL - 100MG
  • CAPSULE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Looking for 104-31-4 / Benzonatate API manufacturers, exporters & distributors?

Benzonatate manufacturers, exporters & distributors 1

89

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

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

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

API | Excipient name

Benzonatate

Synonyms

104-31-4, Benzononatine, Tessalon, Benzononantin, Exangit, Ventussin

Cas Number

104-31-4

About Benzonatate

Benzonatate is an oral antitussive drug used in the relief and suppression of cough in patients older than ten years of age. Currently, benzonatate is the only non-narcotic antitussive available as a prescription drug. It works to reduce the activity of cough reflex by desensitizing the tissues of the lungs and pleura involved in the cough reflex. Benzonatate was approved by the FDA in 1958 under the market name Tessalon Perles. Because its chemical structure resembles that of the anesthetic agents in the para-amino-benzoic acid class (such as [procaine] and [tetracaine]), benzonatate exhibits anesthetic or numbing action. Although it not prone to drug misuse or abuse, benzonatate is associated with a risk for severe toxicity and overdose, especially in children.

Benzonatate Manufacturers

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

Benzonatate Suppliers

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

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

Benzonatate USDMF

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

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

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

Benzonatate KDMF

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

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

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

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

Benzonatate GMP

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

Benzonatate CoA

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

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

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