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List of Korea Drug Master Files (KDMF) for Prestwick3_000012 Active Pharmaceutical Ingredient submitted to the Review Authority in Korea and listed on PharmaCompass.com

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Hiple Co., Ltd.
2022-05-03
20220503-209-J-1282
Formosa Laboratories, Inc...
Taiwan
36 Hoping Street, Louchu,...
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  • 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  • CAPSULE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

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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.

Prestwick3_000012 Manufacturers

A Prestwick3_000012 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prestwick3_000012, including repackagers and relabelers. The FDA regulates Prestwick3_000012 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prestwick3_000012 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 Prestwick3_000012 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Prestwick3_000012 Suppliers

A Prestwick3_000012 supplier is an individual or a company that provides Prestwick3_000012 active pharmaceutical ingredient (API) or Prestwick3_000012 finished formulations upon request. The Prestwick3_000012 suppliers may include Prestwick3_000012 API manufacturers, exporters, distributors and traders.

click here to find a list of Prestwick3_000012 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Prestwick3_000012 KDMF

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

Pharmaceutical companies submit a Prestwick3_000012 Drug Master File in Korea (Prestwick3_000012 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Prestwick3_000012. The MFDS reviews the Prestwick3_000012 KDMF as part of the drug registration process and uses the information provided in the Prestwick3_000012 KDMF to evaluate the safety and efficacy of the drug.

After submitting a Prestwick3_000012 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 Prestwick3_000012 API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Prestwick3_000012 suppliers with KDMF on PharmaCompass.

Prestwick3_000012 Manufacturers | Traders | Suppliers

Prestwick3_000012 Manufacturers, Traders, Suppliers 1
79

We have 1 companies offering Prestwick3_000012

Get in contact with the supplier of your choice:

  1. Formosa Laboratories
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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