LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
01 1LGM Pharma
02 1HRV Global Life Sciences
03 1Medichem S.A
04 1Actavis Inc
05 1Aspire Lifesciences Pvt Ltd
06 2Cipla
07 1Globofarm International
08 1Hetero Drugs
09 1Hunan Huateng Pharmaceutical Co ltd
10 1Jiangsu Joyglory Pharmaceutical
11 2MSN Laboratories
12 1Megafine Pharma (P) Limited
13 1Natco Pharma
14 1Raghava Life Sciences
15 1Sun Pharmaceutical Industries Limited
16 1TATEYAMA KASEI CO LTD
17 1Tianjin Weijie Pharmaceutical Co., Ltd.
18 1Viatris
19 1Zhejiang Huahai Pharmaceutical
01 4China
02 12India
03 1Ireland
04 1Japan
05 1Spain
06 2U.S.A
01 9Active
02 1Inactive
03 11Blank
01 21Blank
01 1302MF10087
02 1302MF10090
03 19Blank
01 1WC-0014
02 1WC-0015
03 1WC-0021
04 1WC-0021n
05 1WC-0087-(Annexure-1)
06 2WC-0142n
07 14Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-12-18
Pay. Date : 2014-11-19
DMF Number : 28781
Submission : 2014-11-18
Status : Active
Type : II
NDC Package Code : 16436-0111
Start Marketing Date : 2014-02-17
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (75kg/75kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-10-20
Pay. Date : 2014-04-15
DMF Number : 24505
Submission : 2010-12-21
Status : Active
Type : II
Date of Issue : 2019-06-03
Valid Till : 2022-06-02
Written Confirmation Number : WC-0015
Address of the Firm :
NDC Package Code : 65015-793
Start Marketing Date : 2015-02-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-12-18
Pay. Date : 2015-09-28
DMF Number : 29792
Submission : 2015-09-09
Status : Active
Type : II
Date of Issue : 2022-07-27
Valid Till : 2025-07-21
Written Confirmation Number : WC-0087-(Annexure-1)
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-12-18
Pay. Date : 2015-09-18
DMF Number : 26156
Submission : 2012-06-08
Status : Active
Type : II
Registration Number : 302MF10087
Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, India.
Initial Date of Registration : 2020-07-22
Latest Date of Registration :
Date of Issue : 2022-06-17
Valid Till : 2025-07-14
Written Confirmation Number : WC-0021n
Address of the Firm :
NDC Package Code : 14501-0059
Start Marketing Date : 2010-03-23
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-09-02
Pay. Date : 2021-07-22
DMF Number : 36105
Submission : 2021-07-22
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-05-23
Pay. Date : 2013-09-27
DMF Number : 27505
Submission : 2013-09-30
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-12-02
Pay. Date : 2016-09-28
DMF Number : 29490
Submission : 2015-06-30
Status : Active
Type : II
Date of Issue : 2022-06-17
Valid Till : 2025-08-04
Written Confirmation Number : WC-0142n
Address of the Firm :
NDC Package Code : 53104-7702
Start Marketing Date : 2016-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30799
Submission : 2016-07-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31133
Submission : 2016-12-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25134
Submission : 2011-09-09
Status : Inactive
Type : II
Date of Issue : 2019-07-15
Valid Till : 2022-07-14
Written Confirmation Number : WC-0021
Address of the Firm :
NDC Package Code : 14501-0059
Start Marketing Date : 2010-03-23
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2019-06-26
Valid Till : 2022-06-25
Written Confirmation Number : WC-0014
Address of the Firm :
Date of Issue : 2022-06-17
Valid Till : 2025-08-04
Written Confirmation Number : WC-0142n
Address of the Firm :
NDC Package Code : 53104-7702
Start Marketing Date : 2016-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Registration Number : 302MF10090
Registrant's Address : 1133 Oe, Imizu City, Toyama Prefecture
Initial Date of Registration : 2020-07-29
Latest Date of Registration :
A Ambrisentan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ambrisentan, including repackagers and relabelers. The FDA regulates Ambrisentan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ambrisentan 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 Ambrisentan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ambrisentan supplier is an individual or a company that provides Ambrisentan active pharmaceutical ingredient (API) or Ambrisentan finished formulations upon request. The Ambrisentan suppliers may include Ambrisentan API manufacturers, exporters, distributors and traders.
click here to find a list of Ambrisentan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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