Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
01 1Sanofi
02 1B.Braun
03 1Corden Pharma Bergamo S.p.A
04 1FDC
05 1HEC Pharm
06 1Hubei Hongyuan Pharmaceutical
07 1J.B.Chemicals & Pharmaceuticals
08 1Medimpex
09 1Sifavitor srl
10 1Signa S.A. de C.V.
11 1Tianjin Zhongan Pharmaceutical Co., Ltd
12 3Unichem Laboratories Limited
13 1Wuhan Wuyao Pharmaceutical
14 1Blank
01 1CRUDE METRONIDAZOLE
02 6METRONIDAZOLE
03 2METRONIDAZOLE BENZOATE
04 1METRONIDAZOLE INJECTION 0.5%,MNFG IN SOUTHERN CALIFORNIA FACILITIES
05 1METRONIDAZOLE U.S.P. XXI
06 3METRONIDAZOLE USP
07 1METRONIDAZOLE USP XX
08 1METRONIDAZOLE USP, NON-STERILE BULK FORM
01 4China
02 1France
03 6India
04 2Italy
05 1Mexico
06 1United Kingdom
07 1Blank
01 2Active
02 14Inactive
01 2Complete
02 14Blank
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 780
Submission : 1964-02-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3904
Submission : 1980-08-04
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-10-24
Pay. Date : 2012-11-21
DMF Number : 3609
Submission : 1979-09-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3675
Submission : 1979-12-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4672
Submission : 1982-10-16
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4025
Submission : 1981-01-06
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-18
Pay. Date : 2012-12-21
DMF Number : 16263
Submission : 2002-11-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5783
Submission : 1985-03-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6356
Submission : 1986-05-12
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4927
Submission : 1983-05-24
Status : Inactive
Type : II
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A PYLERA-1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of PYLERA-1, including repackagers and relabelers. The FDA regulates PYLERA-1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. PYLERA-1 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A PYLERA-1 supplier is an individual or a company that provides PYLERA-1 active pharmaceutical ingredient (API) or PYLERA-1 finished formulations upon request. The PYLERA-1 suppliers may include PYLERA-1 API manufacturers, exporters, distributors and traders.
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A PYLERA-1 DMF (Drug Master File) is a document detailing the whole manufacturing process of PYLERA-1 active pharmaceutical ingredient (API) in detail. Different forms of PYLERA-1 DMFs exist exist since differing nations have different regulations, such as PYLERA-1 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A PYLERA-1 DMF submitted to regulatory agencies in the US is known as a USDMF. PYLERA-1 USDMF includes data on PYLERA-1's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The PYLERA-1 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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