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

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01 Daewoong Bio Co., Ltd. (1)

02 Hawon Fine Chemical Co., Ltd. (1)

03 Hwail Pharmaceutical Co., Ltd. (1)

04 Inist ST Co., Ltd. @Shaanxi Baoxin Pharmaceutical Co., Ltd (1)

05 Pen Tsao Chemical & Pharmaceutical Industry Co., Ltd. (5)

06 Samhwa Biopharm Co., Ltd. (1)

07 [Crude product manufacturer ②] Shaanxi Baoxin Pharmaceutical Co., Ltd.@[Crude product manufacturer ①] Zhejiang Qiming Pharmaceutical Co., Ltd.@NGChem Life Science Co., Ltd._x000D_ (1)

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01 Ace Biopharm Co., Ltd. (1)

02 Daesin Pharmaceutical Co., Ltd. (1)

03 Daewoong Bio Co., Ltd. (1)

04 ENGCHEM Life Science Co., Ltd. (1)

05 Hawon Fine Chemical Co., Ltd. (1)

06 Hiple Co., Ltd. (1)

07 Hwail Pharmaceutical Co., Ltd. (1)

08 Inist ST Co., Ltd. (1)

09 Samhwa Biopharm Co., Ltd. (1)

10 Shinil Pharmaceutical Co., Ltd. (1)

11 Wonpoong Pharmaceutical Co., Ltd. (1)

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01 Talniflumate (11)

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01 China (6)

02 South Korea (5)

URL Supplier Web Content
Daewoong Bio Co., Ltd.
2010-01-15
20100115-119-G-78-08
Daewoong Bio Co., Ltd.
South Korea
35-9, Jaekongdan 4-gil, H...
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Hwail Pharmaceutical Co., Ltd.
2009-11-12
20091112-119-G-52-05
Hwail Pharmaceutical Co.,...
South Korea
57, Jaekongdan 3-gil, Hya...
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Inist ST Co., Ltd.
2009-10-27
20091027-119-G-46-04
Inist ST Co., Ltd. @Shaan...
South Korea
500 Sinnae-ro, Geumwang-e...
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Hawon Fine Chemical Co., Ltd.
2009-09-24
20090924-119-G-37-03
Hawon Fine Chemical Co., ...
South Korea
404-18 Nojang-ri, Jeondon...
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Daesin Pharmaceutical Co., Ltd.
2010-03-31
20100331-119-G-45-10
Pen Tsao Chemical & Pharm...
China
2-Tieli Road, Baoshan Dis...
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Shinil Pharmaceutical Co., Ltd.
2011-03-31
20100331-119-G-45-10(1)
Pen Tsao Chemical & Pharm...
China
2-Tieli Road, Baoshan Dis...
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Hiple Co., Ltd.
2011-11-25
20100331-119-G-45-10(4)
Pen Tsao Chemical & Pharm...
China
2-Tieli Road, Baoshan Dis...
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Ace Biopharm Co., Ltd.
2014-10-17
20100331-119-G-45-10(7)
Pen Tsao Chemical & Pharm...
China
2 Tie Li Road, Baoshan Di...
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Wonpoong Pharmaceutical Co., Ltd.
2012-03-16
20100331-119-G-45-10(6)
Pen Tsao Chemical & Pharm...
China
2-Tieli Road, Baoshan Dis...
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Samhwa Biopharm Co., Ltd.
2009-09-24
20090924-119-G-32-02
Samhwa Biopharm Co., Ltd.
South Korea
150 Hyeopjeong-ro, Siheun...
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Looking for 66898-62-2 / Talniflumate API manufacturers, exporters & distributors?

Talniflumate manufacturers, exporters & distributors 1

28

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

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

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

API | Excipient name

Talniflumate

Synonyms

66898-62-2, Somalgen, Lomucin, Talniflumato, Ba 7602-06, Ba-7602-06

Cas Number

66898-62-2

Unique Ingredient Identifier (UNII)

JFK78S0U9S

About Talniflumate

Talniflumate, is an anti-inflammatory molecule studied and used as a mucin regulator in the treatment of cystic fibrosis, chronic obstructive pulmonary disease (COPD) and asthma. In addition, it is used in inflammatory conditions such as rheumatoid arthritis. Phase I trials with talniflumate for the treatment of cystic fibrosis and COPD were completed in August 2001, and phase II trials were performed in Ireland for the treatment of cystic fibrosis but this research has now been discontinued. Talniflumate has been approved for approximately 20 years in Argentina other countries (excluding the United States, Europe, and Japan).

Talniflumate Manufacturers

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

Talniflumate Suppliers

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

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

Talniflumate KDMF

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

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

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

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

Talniflumate Manufacturers | Traders | Suppliers

Talniflumate Manufacturers, Traders, Suppliers 1
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We have 7 companies offering Talniflumate

Get in contact with the supplier of your choice:

  1. Daewoong Pharmaceutical
  2. Hwail Pharm Co., Ltd
  3. Inist
  4. Korea Fine Chemical
  5. Pen Tsao Chemical
  6. Samhwa Biopharm
  7. Shaanxi Baoxin Pharmaceutical
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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