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

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01 Polpharma (1)

02 Alembic Pharmaceuticals Limited (1)

03 Ami Lifesciences Private Limited (2)

04 Amoli Organics (1)

05 Apotex Pharmachem (1)

06 Aurobindo Pharma Limited (1)

07 Azico Biophore India Pvt. Ltd (1)

08 Glenmark Life Sciences (2)

09 HEC Pharm (1)

10 HONOUR LAB LTD (1)

11 Jubilant Generics (1)

12 Lunan Pharmaceutical (1)

13 MSN Laboratories (2)

14 Macleods Pharmaceuticals Limited (1)

15 Orchid Pharma (1)

16 Qilu Tianhe Pharmaceutical Co., Ltd. (1)

17 RANBAXY LABORATORIES LIMITED (2)

18 SMS Pharmaceuticals (1)

19 TOPHARMAN SHANDONG CO LTD (1)

20 Teva API (1)

21 Unichem Laboratories Limited (1)

22 Viatris (1)

23 Zhejiang Huahai Pharmaceutical (1)

24 Zhejiang Yongning Pharmaceutical Co., Lt (1)

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01 TADALAFIL (13)

02 TADALAFIL (NON STERILE BULK) DRUG SUBSTANCE (1)

03 TADALAFIL NON-STERILE BULK DRUG SUBSTANCE (1)

04 TADALAFIL USP (8)

05 TADALAFIL USP (D150 PROCESS) (1)

06 TADALAFIL USP (NON-STERILE DRUG SUBSTANCE) (1)

07 TADALAFIL USP [ROUTE CODE - "TD"] (1)

08 TADALAFIL USP [ROUTE CODE - "TP"] (1)

09 TADALAFIL-USP (1)

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01 Canada (1)

02 China (6)

03 India (18)

04 Israel (1)

05 Poland (1)

06 U.S.A (1)

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01 Active (26)

02 Inactive (2)

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01 Complete (19)

02 Blank (9)

URL Supplier Web Content
22707
Active
2009-03-31
Complete
2013-02-22
2012-11-02
II
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URL Supplier Web Content
25815
Active
2012-02-22
N/A
II
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URL Supplier Web Content
25694
Active
2012-01-18
Complete
2013-10-31
2013-09-18
II
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URL Supplier Web Content
22530
Active
2009-02-16
N/A
II
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URL Supplier Web Content
25513
Active
2011-11-15
Complete
2014-01-24
2013-11-27
II
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URL Supplier Web Content
20962
Active
2007-10-22
N/A
II
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URL Supplier Web Content
24206
Active
2010-09-28
Complete
2015-12-04
2014-11-13
II
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URL Supplier Web Content
20884
Active
2007-09-26
Complete
2016-07-28
2016-07-18
II
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URL Supplier Web Content
20640
Active
2007-06-15
Complete
2013-10-31
2013-08-27
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Looking for 171596-29-5 / Tadalafil API manufacturers, exporters & distributors?

Tadalafil manufacturers, exporters & distributors 1

29

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

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

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

API | Excipient name

Tadalafil

Synonyms

Cialis, 171596-29-5, Ic351, Tadanafil, Adcirca, Ic 351

Cas Number

171596-29-5

Unique Ingredient Identifier (UNII)

742SXX0ICT

About Tadalafil

A carboline derivative and PHOSPHODIESTERASE 5 INHIBITOR that is used primarily to treat ERECTILE DYSFUNCTION; BENIGN PROSTATIC HYPERPLASIA and PRIMARY PULMONARY HYPERTENSION.

Tadalafil Manufacturers

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

Tadalafil Suppliers

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

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

Tadalafil USDMF

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

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

click here to find a list of Tadalafil 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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