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List of Drug Master Files (KDMF) for Fexofenadine Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 M/S.Virupaksha Organics Ltd (2)

02 EUROAPI Germany GmbH (1)

03 Dr. Reddy's Laboratories Ltd. (1)

04 Dongbang FTL Co., Ltd. (1)

05 Ind-Swift Laboratories Limited (1)

06 Vasudha Pharma Chem Limited (2)

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01 Aging Life Science Co., Ltd. (1)

02 Bahnsen Co., Ltd. (1)

03 Dongbang FTL Co., Ltd. (1)

04 Handok Co., Ltd. (2)

05 SG Biochem Co., Ltd. (1)

06 Sangjin Trading Co., Ltd. (1)

07 Sungjin Exim Co., Ltd. (1)

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01 Fexofenadine Hydrochloride (8)

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01 France (1)

02 India (6)

03 South Korea (1)

Handok Co., Ltd.
2023-09-06
20220324-209-J-1154(A)
M/S.Virupaksha Organics L...
India
Sy.No. 10, Gaddapothram V...
Virupaksha Company Banner

Iran Expo

Not Confirmed

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Handok Co., Ltd.
2021-04-23
20210423-209-J-951
EUROAPI Germany GmbH
Germany
Brüningstraße 50, D711,...
Sangjin Trading Co., Ltd.
2022-10-06
20221006-209-J-1373
Dr. Reddy's Laboratories ...
India
Peddadevulapalli Village,...
Bahnsen Co., Ltd.
2022-03-24
20220324-209-J-1154
M/S.Virupaksha Organics L...
India
Sy.No. 10, Gaddapothram V...
Virupaksha Company Banner

Iran Expo

Not Confirmed

envelop Contact Supplier
URL Supplier Web Content
Dongbang FTL Co., Ltd.
2019-04-23
20190423-209-J-337
Dongbang FTL Co., Ltd.
South Korea
78, Jaekongdan 4-gil, Hya...
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Sungjin Exim Co., Ltd.
2020-12-07
20201207-209-J-638
Ind-Swift Laboratories Li...
India
Village Bhagwanpur, Barwa...
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Aging Life Science Co., Ltd.
2018-11-26
20181126-209-J-89
Vasudha Pharma Chem Limit...
India
Unit-II, Plot No. 79., JN...
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SG Biochem Co., Ltd.
2021-10-20
20181126-209-J-89(1)
Vasudha Pharma Chem Limit...
India
Unit-II, Plot No. 79., JN...
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Looking for 153439-40-8 / Fexofenadine Hydrochloride API manufacturers, exporters & distributors?

Fexofenadine Hydrochloride manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Fexofenadine Hydrochloride

Synonyms

153439-40-8, Fexofenadine hcl, Allegra, Telfast, 2-(4-(1-hydroxy-4-(4-(hydroxydiphenylmethyl)piperidin-1-yl)butyl)phenyl)-2-methylpropanoic acid hydrochloride, Mdl 16,455a

Cas Number

153439-40-8

Unique Ingredient Identifier (UNII)

2S068B75ZU

About Fexofenadine Hydrochloride

Fexofenadine Hydrochloride is the hydrochloride salt form of fexofenadine, a carboxylated metabolic derivative of terfenadine and second generation, long-lasting selective histamine H1 receptor antagonist, with antihistaminic activity. Upon administration, fexofenadine competitively binds of peripheral H1-receptors in the gastrointestinal (GI) tract, blood vessels, and bronchial smooth muscle. This prevents binding of histamine to peripheral H1-receptors and prevents their activation. This prevents a histamine-mediated allergic reaction. Fexofenadine does not cross the blood-brain-barrier (BBB).

Fexofenadine Manufacturers

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

Fexofenadine Suppliers

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

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

Fexofenadine KDMF

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

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

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

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

Fexofenadine Manufacturers | Traders | Suppliers

Fexofenadine Manufacturers, Traders, Suppliers 1
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We have 6 companies offering Fexofenadine

Get in contact with the supplier of your choice:

  1. EUROAPI
  2. Dr. Reddy's Laboratories
  3. Virupaksha Organics
  4. Dongbang FTL
  5. Indoco Remedies Limited
  6. Vasudha Pharma Chem
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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