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List of Drug Master Files (DMF) of Benzonatate Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Ami Lifesciences Private Limited (1)

02 Catalent Pharma Solutions (1)

03 Formosa Laboratories (1)

04 Grace (1)

05 KINGLAND CHEMICALS CO LTD (1)

06 Novartis Pharmaceuticals Corporation (1)

07 Siegfried AG (1)

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01 BENZONATATE (3)

02 BENZONATATE USP (2)

03 TESSALON 100 MG AND 200 MG SOFTGEL CAPSULES AND BENZONATATE 100 MG AND 200 MG SOFTGEL CAPSULES (1)

04 TESSALON DRUG SUBSTANCE, (BENZONATATE, USP) (1)

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01 China (1)

02 India (1)

03 Switzerland (2)

04 Taiwan (1)

05 U.S.A (2)

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01 Active (4)

02 Inactive (3)

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01 Complete (3)

02 Blank (4)

URL Supplier Web Content
39002
Active
2023-12-04
N/A
II
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URL Supplier Web Content
12327
Inactive
1997-01-21
N/A
II
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21703
Active
2008-06-16
Complete
2014-04-03
2013-05-03
II
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5196
Active
1983-12-13
Complete
2013-06-06
2013-05-23
II
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24194
Inactive
2010-09-20
N/A
II
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URL Supplier Web Content
12421
Inactive
1997-03-14
N/A
II
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7843
Active
1988-12-19
Complete
2014-10-31
2014-10-23
II
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Looking for 104-31-4 / Benzonatate API manufacturers, exporters & distributors?

Benzonatate manufacturers, exporters & distributors 1

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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 Manufacturers | Traders | Suppliers

Benzonatate Manufacturers, Traders, Suppliers 1
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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