Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
01 1Interquim SA
02 1Veranova
03 1ALP Pharm
04 1Aurobindo Pharma Limited
05 1Chongqing Huapont Pharmaceutical
06 1Glenmark Life Sciences
07 1Hefei TianRui Pharmaceutical Chemical
08 1Hetero Drugs
09 1MSN Laboratories
10 1ScinoPharm Taiwan, Ltd
11 1Torrent Pharmaceuticals Limited
12 1Viatris
13 1Zydus Lifesciences
01 10ROFLUMILAST
02 2ROFLUMILAST USP
03 1ROFLUMILAST [ROUTE CODE - RO"]
01 3China
02 6India
03 1Spain
04 1Taiwan
05 2U.S.A
01 13Active
01 10Complete
02 3Blank
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-05
Pay. Date : 2014-07-23
DMF Number : 28471
Submission : 2014-07-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-02-28
Pay. Date : 2017-09-25
DMF Number : 32093
Submission : 2017-10-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27779
Submission : 2014-03-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-06-29
Pay. Date : 2018-06-04
DMF Number : 32851
Submission : 2018-06-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-21
Pay. Date : 2014-09-10
DMF Number : 28506
Submission : 2014-07-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-11-17
Pay. Date : 2014-08-14
DMF Number : 28516
Submission : 2014-08-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-27
Pay. Date : 2014-07-03
DMF Number : 27612
Submission : 2013-11-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-09-08
Pay. Date : 2014-03-13
DMF Number : 26764
Submission : 2012-12-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-11-11
Pay. Date : 2014-08-04
DMF Number : 28440
Submission : 2014-09-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-05
Pay. Date : 2014-10-14
DMF Number : 28657
Submission : 2014-10-31
Status : Active
Type : II
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.
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.
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.
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