DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories
02 1Moehs Iberica
03 1ALP Pharm
04 1Alkem Laboratories
05 1Arch Pharmalabs
06 2Arene Lifesciences
07 1Aurobindo Pharma Limited
08 1Aurore Life Sciences
09 1Cadila Pharmaceuticals
10 1Changzhou Ruiming Pharmaceutical
11 1Cipla
12 2Esteve Quimica
13 1Gedeon Richter
14 3Glochem Industries
15 3Hetero Drugs
16 1Ipca Laboratories
17 2Lek Pharmaceuticals
18 1Lupin Ltd
19 1Orchid Pharma
20 1SYNTHON Chemicals GmbH & Co. KG
21 1Second Pharma Co
22 1Shandong Xinhua Pharmaceutical
23 1Smruthi Organics
24 1Srini Pharmaceuticals
25 2Teva Pharmaceutical Industries
26 1Unichem Laboratories Limited
27 3Viatris
28 1Zhejiang Huahai Pharmaceutical
29 2Zydus Lifesciences
30 1Blank
01 5AMLODIPINE BESILATE
02 5AMLODIPINE BESILATE USP
03 1AMLODIPINE BESILATE USP (AYP)
04 9AMLODIPINE BESYLATE
05 1AMLODIPINE BESYLATE (DRUG SUBSTANCE, NON-STERILE)
06 1AMLODIPINE BESYLATE (NON-STERILE DRUG SUBSTANCE)
07 1AMLODIPINE BESYLATE (PROCESS 1)
08 1AMLODIPINE BESYLATE (PROCESS 2)
09 1AMLODIPINE BESYLATE (PROCESS II)
10 1AMLODIPINE BESYLATE (PROCESS-II)
11 1AMLODIPINE BESYLATE MONOHYDRATE
12 12AMLODIPINE BESYLATE USP
13 1AMLODIPINE BESYLATE USP (ADP)
14 1AMLODIPINE BESYLATE USP (PROCESS-I)
01 5China
02 1Germany
03 1Hungary
04 23India
05 2Israel
06 2Slovenia
07 3Spain
08 3U.S.A
09 1Blank
01 23Active
02 18Inactive
01 18Complete
02 23Blank
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-21
Pay. Date : 2013-05-10
DMF Number : 16473
Submission : 2003-03-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17070
Submission : 2003-12-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-08
Pay. Date : 2012-12-17
DMF Number : 18965
Submission : 2005-11-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-06-19
Pay. Date : 2013-06-07
DMF Number : 16911
Submission : 2003-09-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-17
Pay. Date : 2017-03-06
DMF Number : 17032
Submission : 2003-12-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-27
Pay. Date : 2012-12-17
DMF Number : 18787
Submission : 2005-09-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-27
Pay. Date : 2014-01-21
DMF Number : 18839
Submission : 2005-10-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-30
Pay. Date : 2012-11-13
DMF Number : 15777
Submission : 2001-12-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-14
Pay. Date : 2013-09-06
DMF Number : 16509
Submission : 2003-04-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18827
Submission : 2005-09-30
Status : Active
Type : II
A Amlodipine Besylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amlodipine Besylate, including repackagers and relabelers. The FDA regulates Amlodipine Besylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amlodipine Besylate 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 Amlodipine Besylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Amlodipine Besylate supplier is an individual or a company that provides Amlodipine Besylate active pharmaceutical ingredient (API) or Amlodipine Besylate finished formulations upon request. The Amlodipine Besylate suppliers may include Amlodipine Besylate API manufacturers, exporters, distributors and traders.
click here to find a list of Amlodipine Besylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Amlodipine Besylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Amlodipine Besylate active pharmaceutical ingredient (API) in detail. Different forms of Amlodipine Besylate DMFs exist exist since differing nations have different regulations, such as Amlodipine Besylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Amlodipine Besylate DMF submitted to regulatory agencies in the US is known as a USDMF. Amlodipine Besylate USDMF includes data on Amlodipine Besylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amlodipine Besylate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Amlodipine Besylate suppliers with USDMF on PharmaCompass.
We have 29 companies offering Amlodipine Besylate
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