01 2Biocon
02 1CHONGQING ZEIN PHARMACEUTICAL CO LTD
03 1Divis Laboratories
04 1Formosa Laboratories
05 1Lunan Pharmaceutical
06 1Mcneil and Argus pharmaceuticals
07 2Murli Krishna Pharma
08 1RANBAXY LABORATORIES LIMITED
09 1Sun Pharmaceutical Industries Limited
10 2Zhejiang Hisun Pharmaceutical
01 6ORLISTAT
02 1ORLISTAT (NON-STERILE BULK)
03 2ORLISTAT PELLETS 50.0% W/W
04 4ORLISTAT USP
01 4China
02 8India
03 1Taiwan
01 9Active
02 4Inactive
01 4Complete
02 9Blank
GDUFA
DMF Review : Complete
Rev. Date : 2023-06-20
Pay. Date : 2023-05-11
DMF Number : 38096
Submission : 2023-04-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24885
Submission : 2011-04-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-06-30
Pay. Date : 2021-05-20
DMF Number : 35884
Submission : 2021-04-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-12
Pay. Date : 2013-08-29
DMF Number : 23978
Submission : 2010-07-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29914
Submission : 2015-10-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26455
Submission : 2012-09-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30780
Submission : 2016-08-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27624
Submission : 2013-09-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-03-22
Pay. Date : 2018-01-19
DMF Number : 32338
Submission : 2018-01-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22110
Submission : 2008-10-24
Status : Inactive
Type : II
A Orlistat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Orlistat, including repackagers and relabelers. The FDA regulates Orlistat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Orlistat 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 Orlistat manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Orlistat supplier is an individual or a company that provides Orlistat active pharmaceutical ingredient (API) or Orlistat finished formulations upon request. The Orlistat suppliers may include Orlistat API manufacturers, exporters, distributors and traders.
click here to find a list of Orlistat suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Orlistat DMF (Drug Master File) is a document detailing the whole manufacturing process of Orlistat active pharmaceutical ingredient (API) in detail. Different forms of Orlistat DMFs exist exist since differing nations have different regulations, such as Orlistat USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Orlistat DMF submitted to regulatory agencies in the US is known as a USDMF. Orlistat USDMF includes data on Orlistat's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Orlistat USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Orlistat suppliers with USDMF on PharmaCompass.
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