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

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01 Interquim SA (1)

02 Veranova (1)

03 ALP Pharm (1)

04 Aurobindo Pharma Limited (1)

05 Chongqing Huapont Pharmaceutical (1)

06 Hefei TianRui Pharmaceutical Chemical (1)

07 Hetero Drugs (1)

08 MSN Laboratories (1)

09 ScinoPharm Taiwan, Ltd (1)

10 Torrent Pharmaceuticals Limited (1)

11 Viatris (1)

12 Zydus Lifesciences (1)

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01 ROFLUMILAST (11)

02 ROFLUMILAST [ROUTE CODE - RO"] (1)

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01 China (3)

02 India (5)

03 Spain (1)

04 Taiwan (1)

05 U.S.A (2)

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01 Active (12)

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01 Complete (10)

02 Blank (2)

32093
Active
2017-10-31
Complete
2018-02-28
2017-09-25
II
URL Supplier Web Content
27779
Active
2014-03-28
N/A
II
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32851
Active
2018-06-01
Complete
2018-06-29
2018-06-04
II
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URL Supplier Web Content
28506
Active
2014-07-22
Complete
2015-01-21
2014-09-10
II
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URL Supplier Web Content
28516
Active
2014-08-27
Complete
2014-11-17
2014-08-14
II
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URL Supplier Web Content
27612
Active
2013-11-30
Complete
2014-08-27
2014-07-03
II
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URL Supplier Web Content
26764
Active
2012-12-27
Complete
2014-09-08
2014-03-13
II
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URL Supplier Web Content
28440
Active
2014-09-04
Complete
2014-11-11
2014-08-04
II
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URL Supplier Web Content
28657
Active
2014-10-31
Complete
2015-01-05
2014-10-14
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Looking for 162401-32-3 / Roflumilast API manufacturers, exporters & distributors?

Roflumilast manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Roflumilast

Synonyms

162401-32-3, Daxas, 3-(cyclopropylmethoxy)-n-(3,5-dichloropyridin-4-yl)-4-(difluoromethoxy)benzamide, Daliresp, By217, Byk20869

Cas Number

162401-32-3

Unique Ingredient Identifier (UNII)

0P6C6ZOP5U

About Roflumilast

Roflumilast is an orally available, long-acting inhibitor of phosphodiesterase (PDE) type 4 (PDE4), with anti-inflammatory and potential antineoplastic activities. Upon administration, roflumilast and its active metabolite roflumilast N-oxide selectively and competitively bind to and inhibit PDE4, which leads to an increase of both intracellular levels of cyclic-3',5'-adenosine monophosphate (cAMP) and cAMP-mediated signaling. cAMP prevents phosphorylation of spleen tyrosine kinase (SYK) and abrogates activation of the PI3K/AKT/mTOR signaling pathway, which may result in the induction of apoptosis. PDE4, a member of the PDE superfamily that hydrolyses cAMP and 3',5'-cyclic guanosine monophosphate (cGMP) to their inactive 5' monophosphates, is upregulated in a variety of cancers and may contribute to chemoresistance; it also plays a key role in inflammation, especially in inflammatory airway diseases.

Roflumilast Manufacturers

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

Roflumilast Suppliers

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

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

Roflumilast USDMF

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

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

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

Roflumilast Manufacturers | Traders | Suppliers

Roflumilast 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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