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

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01 ACS DOBFAR SPA (1)

02 Apotex Fermentation Inc. (1)

03 Astellas Pharma (1)

04 Biocon (3)

05 CKD Bio Corporation (1)

06 Chunghwa Chemical Synthesis & Biotech (3)

07 Concord Biotech (2)

08 Farmhispania (1)

09 Hangzhou Huadong Medicine Group Kangrun Pharmaceutical (1)

10 Hangzhou Zhongmei Huadong Pharmaceutical (1)

11 JOYANG LABORATORIES (1)

12 Lek Pharmaceuticals (2)

13 Lunan Pharmaceutical (2)

14 Murli Krishna Pharma (1)

15 North China Pharmaceutical Huasheng Co Ltd (1)

16 Teva API (1)

17 Zhejiang Hisun Pharmaceutical (2)

18 Blank (1)

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01 MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES FOR FK506 (TACROLIMUS) OINTMENT FOR CLINICAL SAMPLES IN MUNCHEN, GERMANY (1)

02 TACROLIMUS (5)

03 TACROLIMUS (FK506) DRUG SUBSTANCE (1)

04 TACROLIMUS (NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT) (1)

05 TACROLIMUS (PROCESS B) (1)

06 TACROLIMUS (PROCESS II) (1)

07 TACROLIMUS (PRODUCT CODE 8000255) (1)

08 TACROLIMUS GRANULES 20% W/W (1)

09 TACROLIMUS MONOHYDRATE (1)

10 TACROLIMUS NON STERILE API (1)

11 TACROLIMUS PELLETS 5.0% W/W (1)

12 TACROLIMUS SD20 (1)

13 TACROLIMUS USP (8)

14 TACROLIMUS USP (PROCESS II) (1)

15 Tacrolimus (1)

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01 Canada (1)

02 China (8)

03 India (6)

04 Israel (1)

05 Italy (1)

06 Japan (1)

07 Slovenia (2)

08 South Korea (1)

09 Spain (1)

10 Taiwan (3)

11 Blank (1)

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01 Active (20)

02 Inactive (6)

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01 Complete (13)

02 Blank (13)

URL Supplier Web Content
28065
Active
2014-03-17
Complete
2014-07-14
2014-03-13
II
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URL Supplier Web Content
16833
Active
2003-09-12
N/A
II
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23365
Active
2009-12-08
Complete
2013-08-07
2013-01-31
II
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18442
Active
2005-06-21
Complete
2013-05-30
2013-05-17
II
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23213
Active
2009-10-26
N/A
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18985
Active
2005-11-28
Complete
2016-04-01
2016-03-09
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18908
Active
2005-10-24
Complete
2013-08-28
2013-08-16
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19979
Active
2006-11-20
Complete
2015-05-28
2015-05-05
II
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27626
Active
2013-09-23
N/A
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27202
Active
2013-06-27
Complete
2013-10-01
2013-06-27
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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 USDMF

A Tacrolimus DMF (Drug Master File) is a document detailing the whole manufacturing process of Tacrolimus active pharmaceutical ingredient (API) in detail. Different forms of Tacrolimus DMFs exist exist since differing nations have different regulations, such as Tacrolimus USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Tacrolimus DMF submitted to regulatory agencies in the US is known as a USDMF. Tacrolimus USDMF includes data on Tacrolimus's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tacrolimus USDMF is kept confidential to protect the manufacturer’s intellectual property.

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

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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