01 1Glochem Industries
02 1Guangzhou Tosun Pharmaceutical
03 2Smruthi Organics
04 1Unichem Laboratories Limited
05 1Unipex
06 1Xian Libang Pharmaceutical Co.,Ltd
01 2China
02 1France
03 4India
01 1Inactive
02 6Blank
01 7Blank
01 7Blank
01 1WC-0013
02 1WC-0063
03 1WC-0158
04 1WC-0158A3-A4-A5
05 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17130
Submission : 2004-01-23
Status : Inactive
Type : II
Date of Issue : 2022-06-30
Valid Till : 2025-07-28
Written Confirmation Number : WC-0063
Address of the Firm :
Registrant Name : Kolon Pharmaceutical Co., Ltd.
Registration Date : 2011-10-21
Registration Number : 20110414-130-H-48-19(4)
Manufacturer Name : Unichem Laboratories Ltd.Unichem Laboratories Ltd.@[Starting Material (Phthaloyl Amlodipine) Manufacturing Plant①] Abhinandan Rasayan Pvt.@[Starting Material (Phthaloyl Amlodipine) Manufacturing Plant②] Unichem Laboratories Limited
Manufacturer Address : Plot No.99, MIDC Area, Dhatav-Roha, Dist. Raigad-402 116, Maharashtra@Plot No. J-54. MIDC. Taloja, Dist Raigad, Maharashtra, India@Plot No. 197, Sector-1, Pithampur, Dist. Dhar (M.P.), India
Date of Issue : 2021-01-25
Valid Till : 2024-01-24
Written Confirmation Number : WC-0158
Address of the Firm :
Date of Issue : 2022-05-11
Valid Till : 2024-01-24
Written Confirmation Number : WC-0158A3-A4-A5
Address of the Firm :
Date of Issue : 2019-09-11
Valid Till : 2022-09-10
Written Confirmation Number : WC-0013
Address of the Firm :
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2024-10-07
Registration Number : 20241007-130-H-426-54
Manufacturer Name : Glochem Industries Private Limited
Manufacturer Address : Survey Nos. 174 to 176, IDA, Bollaram, Jinnaram Mandal, Sangareddy District - 502 325, Telangana State, INDIA
23
PharmaCompass offers a list of Amlodipine Maleate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Amlodipine Maleate manufacturer or Amlodipine Maleate supplier for your needs.
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A Amlodipine Maleate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amlodipine Maleate, including repackagers and relabelers. The FDA regulates Amlodipine Maleate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amlodipine 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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A Amlodipine Maleate supplier is an individual or a company that provides Amlodipine Maleate active pharmaceutical ingredient (API) or Amlodipine Maleate finished formulations upon request. The Amlodipine Maleate suppliers may include Amlodipine Maleate API manufacturers, exporters, distributors and traders.
click here to find a list of Amlodipine Maleate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
We have 6 companies offering Amlodipine Maleate
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