Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
01 1Aarti Pharmalabs
02 1Inke S.A
03 1Medichem S.A
04 2Neuland Laboratories
05 1Zeon Pharma Industries India Pvt Ltd
06 1Farmhispania
07 1Apotex Pharmachem
08 1CHEMO
09 1Changzhou Pharmaceutical Factory
10 1ChemSource
11 1DEAFARMA
12 1Esteve Quimica
13 1GULF OIL Corporation Limited IN 500 018 Hyderabad
14 1Gedeon Richter
15 1Hangzhou Think Chemical Co.Ltd
16 1Hengdian Group
17 1Jin Dun Medical
18 1Kongo Chemical Co., Ltd.
19 2Krka
20 1Lek Pharmaceuticals
21 2Maprimed
22 1Merck & Co
23 1Nosch Labs Pvt
24 1Ohara Pharmaceutical
25 1Qingdao Qingmei Biotech
26 1RANBAXY LABORATORIES LIMITED
27 1Ramdev Chemicals Pvt Ltd
28 2Sri Krishna Pharmaceuticals
29 1Srini Pharmaceuticals
30 1Wockhardt
31 1Zhejiang Changming Pharmaceuticals
32 1Zhejiang Huahai Pharmaceutical
01 2Argentina
02 1Canada
03 7China
04 1Hungary
05 12India
06 1Italy
07 2Japan
08 3Slovenia
09 5Spain
10 2U.S.A
01 5Active
02 12Inactive
03 19Blank
01 1Expired
02 8Valid
03 1Withdrawn by EDQM Failure to CEP procedure
04 3Withdrawn by Holder
05 23Blank
01 1217MF11207
02 1219MF10252
03 1220MF10175
04 1227MF10268
05 32Blank
01 1WC-0027
02 1WC-0033
03 1WC-0036
04 1WC-0037
05 1WC-0128
06 31Blank
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
Certificate Number : R1-CEP 2000-070 - Rev 04
Issue Date : 2019-02-21
Type : Chemical
Substance Number : 1420
Status : Valid
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2005-08-31
Registration Number : 20050831-12-B-49-06
Manufacturer Name : Inke, SA (Group Vita)
Manufacturer Address : Area Industrial del Llobregat, C/Argent 1, 08755 Castellbisbal Barcelona
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13055
Submission : 1998-06-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15434
Submission : 2001-05-15
Status : Active
Type : II
Certificate Number : R1-CEP 2003-078 - Rev 14
Issue Date : 2023-06-07
Type : Chemical
Substance Number : 1420
Status : Valid
Registration Number : 219MF10252
Registrant's Address : 11th Floor (5th Office Level), Phoenix IVY Building, Plot No. 573A-Ⅲ, Road No. 82, Jubilee Hills,Hyderabad-33 Telangana, India
Initial Date of Registration : 2007-07-26
Latest Date of Registration : --
Date of Issue : 2022-07-28
Valid Till : 2025-06-16
Written Confirmation Number : WC-0036
Address of the Firm :
NDC Package Code : 58032-0125
Start Marketing Date : 2017-11-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2018-10-14
Registration Number : 20050831-12-B-44-02(1)
Manufacturer Name : Neuland Lab. Ltd
Manufacturer Address : Sy.No: 347,473,474,490/2 Bonthapalli (V), Veerabhadraswamy temple road, Jinnaram (M), Medak (Dist.)-502 313 Telangana, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11525
Submission : 1995-05-19
Status : Active
Type : II
Certificate Number : R1-CEP 2006-104 - Rev 01
Issue Date : 2013-03-14
Type : Chemical
Substance Number : 1420
Status : Valid
NDC Package Code : 17404-0009
Start Marketing Date : 2000-02-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-06-28
Pay. Date : 2016-06-16
DMF Number : 19984
Submission : 2006-11-17
Status : Active
Type : II
Date of Issue : 2022-06-08
Valid Till : 2025-06-16
Written Confirmation Number : WC-0037
Address of the Firm :
NDC Package Code : 58032-0125
Start Marketing Date : 2017-11-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2018-10-14
Registration Number : 20050831-12-B-44-02(1)
Manufacturer Name : Neuland Lab. Ltd
Manufacturer Address : Sy.No: 347,473,474,490/2 Bonthapalli (V), Veerabhadraswamy temple road, Jinnaram (M), Medak (Dist.)-502 313 Telangana, India
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-12-11
Pay. Date : 2018-12-04
DMF Number : 14355
Submission : 1999-06-22
Status : Active
Type : II
Certificate Number : CEP 2000-053 - Rev 07
Issue Date : 2023-11-23
Type : Chemical
Substance Number : 1420
Status : Valid
Registration Number : 227MF10268
Registrant's Address : Xunqiao, Linhai, Zhejiang 317024, China
Initial Date of Registration : 2015-11-19
Latest Date of Registration : --
NDC Package Code : 64220-143
Start Marketing Date : 2008-06-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2024-07-25
Registration Number : 20050831-12-B-51-08(4)
Manufacturer Name : Zhejiang Huahai Pharmaceutical Co., Ltd.
Manufacturer Address : Lizhuang, Xunqiao, Linhai, 317024, Zhejiang, China
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12939
Submission : 1998-04-08
Status : Inactive
Type : II
Certificate Number : R1-CEP 2001-408 - Rev 03
Issue Date : 2010-11-25
Type : Chemical
Substance Number : 1420
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19058
Submission : 2005-12-21
Status : Inactive
Type : II
Date of Issue : 2014-03-06
Valid Till : 2016-07-02
Written Confirmation Number : WC-0128
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11866
Submission : 1996-02-27
Status : Inactive
Type : II
Certificate Number : R1-CEP 2000-258 - Rev 04
Issue Date : 2020-10-28
Type : Chemical
Substance Number : 1420
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11656
Submission : 1995-09-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20317
Submission : 2007-03-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12780
Submission : 1997-12-10
Status : Inactive
Type : II
Certificate Number : R0-CEP 2001-062 - Rev 00
Issue Date : 2005-01-17
Type : Chemical
Substance Number : 1420
Status : Expired
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12809
Submission : 1997-12-29
Status : Inactive
Type : II
Certificate Number : R1-CEP 2000-212 - Rev 02
Issue Date : 2010-09-10
Type : Chemical
Substance Number : 1420
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15005
Submission : 2000-08-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11170
Submission : 1994-10-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14938
Submission : 2000-06-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13114
Submission : 1998-08-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13820
Submission : 1998-11-05
Status : Inactive
Type : II
Certificate Number : R1-CEP 2000-084 - Rev 01
Issue Date : 2008-03-14
Type : Chemical
Substance Number : 1420
Status : Withdrawn by Holder
Certificate Number : R0-CEP 2005-206 - Rev 00
Issue Date : 2007-08-01
Type : Chemical
Substance Number : 1420
Status : Withdrawn by EDQM F...
Certificate Number : R0-CEP 2022-175 - Rev 00
Issue Date : 2023-04-26
Type : Chemical
Substance Number : 1420
Status : Valid
Date of Issue : 2019-07-29
Valid Till : 2022-06-28
Written Confirmation Number : WC-0033
Address of the Firm :
Date of Issue : 2022-05-02
Valid Till : 2025-07-25
Written Confirmation Number : WC-0027
Address of the Firm :
Certificate Number : R1-CEP 2009-367 - Rev 01
Issue Date : 2016-05-27
Type : Chemical
Substance Number : 1420
Status : Valid
Certificate Number : R1-CEP 2001-308 - Rev 05
Issue Date : 2020-10-02
Type : Chemical
Substance Number : 1420
Status : Valid
A Enalapril Maleate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Enalapril Maleate, including repackagers and relabelers. The FDA regulates Enalapril Maleate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Enalapril Maleate 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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