loader
Please Wait
Applying Filters...
Close
4

Seqens Seqens

X

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

Client Email Product
Menu
Filters Filter
Cross PopUp
FILTER :

filter

01 Interquim, S.A. (1)

02 MSN Laboratories PVT.LTD (1)

03 MSN Laboratories Private Limited (1)

04 Siegfried Evionnaz SA_x000D_ @[micronization process] Jetpharma SA (1)

05 Takeda GmbH, Production site Singen (1)

filter

01 AstraZeneca Korea Co., Ltd. (2)

02 Pharmapia Co., Ltd. (2)

03 Seongui Bio Co., Ltd. (1)

filter

01 Micronized roflumilast (1)

02 Roflumilast (4)

filter

01 India (2)

02 Japan (1)

03 Spain (1)

04 Switzerland (1)

Seongui Bio Co., Ltd.
2016-12-29
Number 259-4-ND
Interquim, S.A.
Spain
Joan Buscalla 10, E-08173...
URL Supplier Web Content
Pharmapia Co., Ltd.
2017-04-03
Number 258-2-ND
MSN Laboratories Private ...
India
Sy. No. 317, 320, 321, 32...
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
URL Supplier Web Content
Pharmapia Co., Ltd.
2021-07-20
Wed258-14-ND
MSN Laboratories PVT.LTD
India
Sy. No. 317 , 320, 321, 3...
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
URL Supplier Web Content
AstraZeneca Korea Co., Ltd.
2014-09-17
Number 5550-4-ND
Siegfried Evionnaz SA_x00...
Switzerland
Route du Simplon 1, 36, 1...
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
URL Supplier Web Content
AstraZeneca Korea Co., Ltd.
2011-04-29
Number 5550-1-ND
Takeda GmbH, Production s...
Germany
Robert-Bosch-Strass 8 782...
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content

Looking for 162401-32-3 / Roflumilast API manufacturers, exporters & distributors?

Roflumilast manufacturers, exporters & distributors 1

48

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 KDMF

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

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

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

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

Roflumilast Manufacturers | Traders | Suppliers

Roflumilast Manufacturers, Traders, Suppliers 1
76

We have 4 companies offering Roflumilast

Get in contact with the supplier of your choice:

  1. Interquim SA
  2. MSN Laboratories
  3. Siegfried AG
  4. Takeda 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.
Post Enquiry
POST ENQUIRY