PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
01 3PMC Isochem
02 1LGM Pharma
03 1Inabata France S.A.S
04 1Gonane Pharma
05 1Jai Radhe Sales
06 1Tenatra Chemie
07 1Bazayan & Co
08 1Cambrex Corporation
09 1Cilag AG
10 2Erregierre SpA
11 1FDC
12 1Gufic Biosciences
13 1Industriale Chimica
14 1Jiangsu Nhwa Pharmaceutical
15 2Johnson & Johnson Innovative Medicine
16 1Olon S.p.A
17 2Sifavitor srl
18 1Suzhou Ryway Biotech
19 1YUNG ZIP CHEMICAL INDUSTRIAL
20 1Blank
01 2China
02 4France
03 6India
04 6Italy
05 1Switzerland
06 1Taiwan
07 4U.S.A
08 1Blank
01 4Active
02 8Inactive
03 13Blank
01 6Valid
02 19Blank
01 25Blank
01 1WC-0055
02 1WC-0256
03 23Blank
PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-10-07
Pay. Date : 2016-04-26
DMF Number : 26872
Submission : 2013-01-31
Status : Active
Type : II
Certificate Number : R0-CEP 2021-076 - Rev 00
Issue Date : 2021-06-01
Type : Chemical
Substance Number : 665
Status : Valid
NDC Package Code : 49632-180
Start Marketing Date : 2015-10-05
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Available Reg Filing : ASMF, FR, BE |
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
Certificate Number : R0-CEP 2019-074 - Rev 00
Issue Date : 2020-09-18
Type : Chemical
Substance Number : 665
Status : Valid
NDC Package Code : 49632-180
Start Marketing Date : 2015-10-05
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Available Reg Filing : ASMF, FR, BE |
PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
Certificate Number : R0-CEP 2020-047 - Rev 00
Issue Date : 2020-09-18
Type : Chemical
Substance Number : 2049
Status : Valid
NDC Package Code : 49632-180
Start Marketing Date : 2015-10-05
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Available Reg Filing : ASMF, FR, BE |
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-06-02
Pay. Date : 2013-07-30
DMF Number : 12857
Submission : 1998-02-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11140
Submission : 1994-10-14
Status : Active
Type : II
NDC Package Code : 52935-0007
Start Marketing Date : 1994-10-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10456
Submission : 1993-08-09
Status : Active
Type : II
Certificate Number : CEP 2003-133 - Rev 02
Issue Date : 2024-07-08
Type : Chemical
Substance Number : 665
Status : Valid
Date of Issue : 2022-06-08
Valid Till : 2025-07-07
Written Confirmation Number : WC-0055
Address of the Firm :
NDC Package Code : 55545-0452
Start Marketing Date : 2003-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2877
Submission : 1977-03-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14237
Submission : 1999-06-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7547
Submission : 1988-06-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12799
Submission : 1997-12-22
Status : Inactive
Type : II
Date of Issue : 2021-04-12
Valid Till : 2024-01-28
Written Confirmation Number : WC-0256
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4689
Submission : 1982-09-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6869
Submission : 1987-03-05
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7039
Submission : 1987-06-24
Status : Inactive
Type : II
Certificate Number : R1-CEP 2006-126 - Rev 03
Issue Date : 2020-09-03
Type : Chemical
Substance Number : 665
Status : Valid
NDC Package Code : 17337-0515
Start Marketing Date : 2017-03-21
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Certificate Number : R1-CEP 2009-072 - Rev 01
Issue Date : 2020-08-04
Type : Chemical
Substance Number : 2049
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11303
Submission : 1994-12-30
Status : Inactive
Type : II
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A Econazole Nitrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Econazole Nitrate, including repackagers and relabelers. The FDA regulates Econazole Nitrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Econazole Nitrate 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 Econazole Nitrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Econazole Nitrate supplier is an individual or a company that provides Econazole Nitrate active pharmaceutical ingredient (API) or Econazole Nitrate finished formulations upon request. The Econazole Nitrate suppliers may include Econazole Nitrate API manufacturers, exporters, distributors and traders.
click here to find a list of Econazole Nitrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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