01 1Aarti Drugs
02 3Cadila Pharmaceuticals
03 1Catalent Pharma Solutions
04 1Divis Laboratories
05 1Glenmark Life Sciences
06 1MERCK & CIE
07 1MSD INTL GMBH
08 2Morepen Laboratories
09 2Quimica Sintetica
10 1RANBAXY LABORATORIES LIMITED
11 1Rolabo Outsourcing
12 1Solara Active Pharma Sciences
13 2Vasudha Pharma Chem
14 2Viatris
15 1Zhejiang Wepon Pharmaceutical
16 3Zydus Lifesciences
17 1Blank
01 9LORATADINE
02 1LORATADINE (PROCESS 2) U.S.P.
03 1LORATADINE SOFTGELS (10 MG)
04 7LORATADINE USP
05 1LORATADINE USP (LCP)
06 1LORATADINE USP (LDP)
07 1LORATADINE USP (PROCESS-II)
08 1LORATADINE USP POWDER
09 2LORATIDINE
10 1LORATIDINE SPECIAL
01 1China
02 15India
03 1Singapore
04 3Spain
05 1Switzerland
06 3U.S.A
07 1Blank
01 14Active
02 11Inactive
01 7Complete
02 18Blank
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-21
Pay. Date : 2013-09-11
DMF Number : 17582
Submission : 2004-07-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19400
Submission : 2006-05-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6626
Submission : 1986-10-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-28
Pay. Date : 2013-09-24
DMF Number : 12650
Submission : 1997-09-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13032
Submission : 1998-06-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11803
Submission : 1995-12-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15251
Submission : 2001-01-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-05-26
Pay. Date : 2014-07-02
DMF Number : 14155
Submission : 1999-05-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-03-30
Pay. Date : 2014-10-10
DMF Number : 20367
Submission : 2007-03-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18702
Submission : 2005-08-25
Status : Active
Type : II
A Loratadine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Loratadine, including repackagers and relabelers. The FDA regulates Loratadine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Loratadine 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 Loratadine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Loratadine supplier is an individual or a company that provides Loratadine active pharmaceutical ingredient (API) or Loratadine finished formulations upon request. The Loratadine suppliers may include Loratadine API manufacturers, exporters, distributors and traders.
click here to find a list of Loratadine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Loratadine DMF (Drug Master File) is a document detailing the whole manufacturing process of Loratadine active pharmaceutical ingredient (API) in detail. Different forms of Loratadine DMFs exist exist since differing nations have different regulations, such as Loratadine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Loratadine DMF submitted to regulatory agencies in the US is known as a USDMF. Loratadine USDMF includes data on Loratadine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Loratadine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Loratadine suppliers with USDMF on PharmaCompass.
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