EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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01 1EUROAPI
02 1Transo-Pharm USA LLC
03 1Curia
04 1Fujifilm Diosynth Biotechnologies
05 1Henan Lihua Pharmaceutical
06 1Hikma Pharmaceuticals
07 1Laboratorio Syntex S.A
08 1Letco Medical
09 1Medisca
10 1Pcca
11 2Pfizer Inc
12 1Shandong Xinhua Pharmaceutical
13 1Spectrum Chemical
14 1Tianjin Tianfa Pharmaceutical Import & Export
15 1Zhejiang Xianju Pharmaceutical Co. Ltd
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01 1Argentina
02 4China
03 1France
04 7U.S.A
05 3United Kingdom
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01 5Valid
02 2Withdrawn by Holder
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01 138779-0154
02 149452-6000
03 151927-1435
04 157582-003
05 160722-1002
06 162991-1206
07 164958-0002
08 165089-0030
09 182298-103
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GDUFA
DMF Review : Reviewed
Rev. Date : 2013-09-05
Pay. Date : 2013-01-02
DMF Number : 2874
Submission : 1977-02-28
Status : Active
Type : II
Certificate Number : R1-CEP 2001-251 - Rev 04
Issue Date : 2021-12-16
Type : Chemical
Substance Number : 354
Status : Valid
NDC Package Code : 82298-103
Start Marketing Date : 2011-02-07
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-12-24
Pay. Date : 2012-12-05
DMF Number : 13173
Submission : 1998-08-06
Status : Active
Type : II
NDC Package Code : 65089-0030
Start Marketing Date : 2002-07-12
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-03-25
Pay. Date : 2014-01-09
DMF Number : 24749
Submission : 2011-03-10
Status : Active
Type : II
Certificate Number : R1-CEP 2005-240 - Rev 04
Issue Date : 2020-02-26
Type : Chemical
Substance Number : 354
Status : Valid
NDC Package Code : 64958-0002
Start Marketing Date : 2003-01-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35461
Submission : 2020-12-22
Status : Active
Type : II
Certificate Number : CEP 2022-349 - Rev 00
Issue Date : 2024-12-17
Type : Chemical
Substance Number : 354
Status : Valid

GDUFA
DMF Review : Reviewed
Rev. Date : 2016-07-05
Pay. Date : 2016-03-16
DMF Number : 30194
Submission : 2015-12-24
Status : Active
Type : II
Certificate Number : CEP 2018-027 - Rev 03
Issue Date : 2025-11-05
Type : Chemical
Substance Number : 354
Status : Valid
NDC Package Code : 60722-1002
Start Marketing Date : 2016-01-06
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16000
Submission : 2002-06-10
Status : Active
Type : II

GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-11
Pay. Date : 2012-12-11
DMF Number : 11289
Submission : 1994-10-07
Status : Active
Type : II
Certificate Number : R1-CEP 2003-135 - Rev 04
Issue Date : 2018-01-15
Type : Chemical
Substance Number : 354
Status : Valid
NDC Package Code : 57582-003
Start Marketing Date : 2012-02-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : DRUG FOR FURTHER PROCESSING

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 : 3956
Submission : 1980-07-17
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 241
Submission : 1957-01-29
Status : Inactive
Type : II

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PharmaCompass offers a list of Prednisone API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Prednisone manufacturer or Prednisone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Prednisone manufacturer or Prednisone supplier.
A Rectodelt manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rectodelt, including repackagers and relabelers. The FDA regulates Rectodelt manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rectodelt 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 Rectodelt manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Rectodelt supplier is an individual or a company that provides Rectodelt active pharmaceutical ingredient (API) or Rectodelt finished formulations upon request. The Rectodelt suppliers may include Rectodelt API manufacturers, exporters, distributors and traders.
click here to find a list of Rectodelt suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
We have 15 companies offering Rectodelt
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