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List of all Manufacturers, Suppliers & Exporters of Roflumilast API listed on PharmaCompass with details of regulatory filings

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01 Interquim SA (1)

02 Veranova (1)

03 LGM Pharma (1)

04 HRV Global Life Sciences (1)

05 ALP Pharm (1)

06 Aspire Lifesciences Pvt Ltd (1)

07 Aurobindo Pharma Limited (1)

08 CHEMO (1)

09 Chongqing Huapont Pharmaceutical (1)

10 DEAFARMA (1)

11 Glenmark Pharmaceuticals (1)

12 Hefei TianRui Pharmaceutical Chemical (1)

13 Hetero Drugs (2)

14 Hunan Huateng Pharmaceutical Co ltd (1)

15 Lusochimica SPA (1)

16 MSN Laboratories (2)

17 Melody Healthcare Pvt Ltd (1)

18 Precise Group (1)

19 ScinoPharm Taiwan, Ltd (1)

20 Torrent Pharmaceuticals Limited (1)

21 Viatris (1)

22 Zydus Lifesciences (1)

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01 China (4)

02 India (12)

03 Italy (2)

04 Spain (2)

05 Taiwan (1)

06 U.S.A (3)

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01 Active (12)

02 Blank (12)

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01 Blank (24)

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01 Blank (24)

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01 WC-0017 (1)

02 WC-0021 (1)

03 WC-0021n (1)

04 WC-0040 (1)

05 WC-0040A3 (1)

06 WC-0157 (1)

07 Blank (18)

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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
28471
Status
Active
Fees Paid
Reviewed
 
Filing Details
ROFLUMILAST
Issue/Submission Date
2014-07-31
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USDMF

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Application Number
32093
Status
Active
Fees Paid
Reviewed
 
Filing Details
ROFLUMILAST
Issue/Submission Date
2017-10-31
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USDMF

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Application Number
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Filing Details
Issue/Submission Date
HRV Global Life Sciences Company Banner

Cophex 2024

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USDMF

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Application Number
28506
Status
Active
Fees Paid
Reviewed
 
Filing Details
ROFLUMILAST
Issue/Submission Date
2014-07-22
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USDMF

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Application Number
28516
Indian CDSCO WC-0040
Status
Active
Fees Paid
Reviewed
 
Valid
2025-07-03
Filing Details
ROFLUMILAST
Roflumilast IH
Issue/Submission Date
2014-08-27
2022-07-04
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USDMF

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Application Number
39317
Status
Active
Fees Unpaid
N/A
 
Filing Details
ROFLUMILAST
Issue/Submission Date
2023-12-22
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USDMF

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Application Number
27779
Status
Active
Fees Unpaid
N/A
 
Filing Details
ROFLUMILAST
Issue/Submission Date
2014-03-28
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USDMF

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Application Number
32851
Indian CDSCO WC-0017
Status
Active
Fees Paid
Reviewed
 
Valid
2025-06-10
Filing Details
ROFLUMILAST
Roflumilast IH
Issue/Submission Date
2018-06-01
2022-06-06
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USDMF

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Application Number
27612
Indian CDSCO WC-0021n
Status
Active
Fees Paid
Reviewed
 
Valid
2025-07-14
Filing Details
ROFLUMILAST [ROUTE CODE - RO"]
Roflumilast IH
Issue/Submission Date
2013-11-30
2022-06-17
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USDMF

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Caution WC

Application Number
28440
Indian CDSCO WC-0157
Status
Active
Fees Paid
Reviewed
 
Expired
2022-07-02
Filing Details
ROFLUMILAST
Roflumilast IH
Issue/Submission Date
2014-09-04
2019-10-11
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USDMF

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Application Number
28657
Status
Active
Fees Paid
Reviewed
 
Filing Details
ROFLUMILAST
Issue/Submission Date
2014-10-31
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USDMF

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Application Number
26764
Status
Active
Fees Paid
Reviewed
 
Filing Details
ROFLUMILAST
Issue/Submission Date
2012-12-27
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USDMF

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Application Number
35661
Status
Active
Fees Paid
Reviewed
 
Filing Details
ROFLUMILAST
Issue/Submission Date
2021-03-11
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USDMF

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Caution WC

Application Number
Indian CDSCO WC-0021
Status
 
Expired
2022-07-14
Filing Details
Roflumilast (IH)
Issue/Submission Date
2019-07-15
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USDMF

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Application Number
Indian CDSCO WC-0040A3
Status
 
Expired
2022-07-03
Filing Details
Roflumilast IH
Issue/Submission Date
2022-02-25
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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.

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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