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

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Korea Astellas Pharmaceutical Co., Ltd.
2012-08-07
20120807-204-I-74-02
Astellas Pharma Inc. Toya...
Japan
2-178 Kojin-machi, Toyama...
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Wonpoong Pharmaceutical Co., Ltd.
2014-01-08
20140108-204-I-133-07
Biocon Limited
India
20th KM, Hosur Road, Elec...
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Ceres F&D Co., Ltd.
2013-03-08
20130308-204-I-272-05
Ceres F&D Co., Ltd.
South Korea
100 Biovalley 2-ro, Jeche...
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Hwail Pharmaceutical Co., Ltd.
2014-04-17
20140417-204-I-289-08
Chunghwa Chemical Synthes...
Taiwan
No.1, Tung-Hsing st., Shu...
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Chong Kun Dang Bio Co., Ltd.
2022-05-24
20220524-204-I-636-10
Chong Kun Dang Bio Co., L...
South Korea
292 Sinwon-ro, Danwon-gu,...
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Chong Kun Dang Bio Co., Ltd.
2012-12-21
20121221-204-I-292-03
Chong Kun Dang Bio Co., L...
South Korea
(15604) 292 Sinwon-ro, Da...
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Hanmi Pharmaceutical Co., Ltd.
2012-05-25
20120302-204-I-23-01(2)
CONCORD BIOTECH LIMITED
India
1482-1486, Trasad Road, D...
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Seongui Bio Co., Ltd.
2012-03-02
20120302-204-I-23-01
CONCORD BIOTECH LIMITED
India
1482-1486, Trasad Road, D...
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Masung LS Co., Ltd.
2023-11-15
20231115-204-I-664-11
Joyang Laboratories
China
No. 9 Haidu North Road, S...
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Farm & Biz Co., Ltd.
2020-09-25
20200925-204-I-611-09
North China Pharmaceutica...
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No.8 Yangzi Road, Shijiaz...
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Chong Kun Dang Co., Ltd.
2017-09-01
20131017-204-I-367-06(1)
Teva Czech Industries sro
Czech Republic
Ostravska 29, cp. 305, 74...
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Samo Pharmaceutical Co., Ltd.
2013-10-17
20131017-204-I-367-06
Teva Czech Industries sro
Czech Republic
Ostravska 29, cp. 305, 74...
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Leeyeon Pharmaceutical Co., Ltd.
2013-02-13
20130213-204-I-291-04
Leeyeon Pharmaceutical Co...
South Korea
69-10 Hansam-ro, Deoksan-...
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  • TABLET, EXTENDED RELEASE;ORAL - EQ 0.75MG BASE
  • TABLET, EXTENDED RELEASE;ORAL - EQ 1MG BASE
  • TABLET, EXTENDED RELEASE;ORAL - EQ 4MG BASE
  • CAPSULE;ORAL - EQ 0.5MG BASE
  • CAPSULE;ORAL - EQ 1MG BASE
  • CAPSULE;ORAL - EQ 5MG BASE

Looking for 104987-11-3 / Tacrolimus API manufacturers, exporters & distributors?

Tacrolimus manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Tacrolimus

Synonyms

Fujimycin, 104987-11-3, Prograf, Tsukubaenolide, Protopic, Fk506

Cas Number

104987-11-3

Unique Ingredient Identifier (UNII)

Y5L2157C4J

About Tacrolimus

A macrolide isolated from the culture broth of a strain of Streptomyces tsukubaensis that has strong immunosuppressive activity in vivo and prevents the activation of T-lymphocytes in response to antigenic or mitogenic stimulation in vitro.

Tacrolimus Manufacturers

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

Tacrolimus Suppliers

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

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

Tacrolimus KDMF

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

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

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

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

Tacrolimus Manufacturers | Traders | Suppliers

Tacrolimus 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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