LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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01 1LGM Pharma
02 1HRV Pharma
03 1Pfizer CentreOne
04 1Excella GmbH
05 1Apotex Pharmachem
06 2Aurisco Pharmaceutical
07 1CHEMO
08 1Dasami Lab
09 1Guangzhou Topwork Chemical
10 1Guangzhou Tosun Pharmaceutical
11 1Henan Lihua Pharmaceutical
12 2Hetero Drugs
13 1Hubei Gedian Humanwell Pharmaceutical
14 4Industriale Chimica
15 1JPN Pharma
16 1MSN Laboratories
17 1Zhejiang Shenzhou Pharmaceutical
18 1Zhejiang Xianju Pharmaceutical Co. Ltd
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01 1Canada
02 8China
03 1Germany
04 6India
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07 2U.S.A
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01 6Active
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01 11Valid
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01 1304MF10019
02 1304MF10031
03 22Blank
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01 1WC-0021
02 1WC-0041
03 1WC-0336
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01 24Blank
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01 10009-5276
02 114501-0007
03 116637-0060
04 116812-001
05 146014-1102
06 151508-213
07 163190-0170
08 163190-0750
09 163190-0800
10 163190-0810
11 168554-0116
12 170966-0033
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01 24Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
NDC Package Code : 0009-5276
Start Marketing Date : 2014-07-03
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 46014-1102
Start Marketing Date : 2013-05-21
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37024
Submission : 2022-07-13
Status : Active
Type : II
Certificate Number : CEP 2022-244 - Rev 00
Issue Date : 2024-02-16
Type : Chemical
Substance Number : 2765
Status : Valid
NDC Package Code : 16637-0060
Start Marketing Date : 2022-06-13
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : Reviewed
Rev. Date : 2019-10-16
Pay. Date : 2019-09-24
DMF Number : 33832
Submission : 2019-05-20
Status : Active
Type : II
Certificate Number : CEP 2025-487 - Rev 00
Issue Date : 2025-11-26
Type : Chemical
Substance Number : 2765
Status : Valid
Registration Number : 304MF10031
Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA
Initial Date of Registration : 2022-02-10
Latest Date of Registration :
Date of Issue : 2025-09-03
Valid Till : 2028-08-08
Written Confirmation Number : WC-0041
Address of the Firm :
NDC Package Code : 68554-0116
Start Marketing Date : 2002-09-27
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 : 19715
Submission : 2006-09-08
Status : Active
Type : II
Certificate Number : CEP 2017-004 - Rev 03
Issue Date : 2023-10-18
Type : Chemical
Substance Number : 2765
Status : Valid
NDC Package Code : 63190-0750
Start Marketing Date : 2006-09-08
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : Reviewed
Rev. Date : 2019-04-15
Pay. Date : 2019-01-29
DMF Number : 32998
Submission : 2018-11-30
Status : Active
Type : II
Certificate Number : CEP 2024-299 - Rev 00
Issue Date : 2024-11-15
Type : Chemical
Substance Number : 2765
Status : Valid
NDC Package Code : 63190-0170
Start Marketing Date : 2006-09-08
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : Reviewed
Rev. Date : 2015-10-30
Pay. Date : 2013-12-02
DMF Number : 27672
Submission : 2013-12-25
Status : Active
Type : II
Certificate Number : CEP 2019-028 - Rev 02
Issue Date : 2025-01-14
Type : Chemical
Substance Number : 2765
Status : Valid
Registration Number : 304MF10019
Registrant's Address : Badu Industrial Park Zone, Tiantai, Zhejiang province, 317200, P. R. China
Initial Date of Registration : 2022-01-26
Latest Date of Registration :
NDC Package Code : 16812-001
Start Marketing Date : 2020-01-01
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19796
Submission : 2006-09-25
Status : Inactive
Type : II

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A eplerenon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of eplerenon, including repackagers and relabelers. The FDA regulates eplerenon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. eplerenon 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 eplerenon supplier is an individual or a company that provides eplerenon active pharmaceutical ingredient (API) or eplerenon finished formulations upon request. The eplerenon suppliers may include eplerenon API manufacturers, exporters, distributors and traders.
click here to find a list of eplerenon suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
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