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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17130
Submission : 2004-01-23
Status : Inactive
Type : II

Date of Issue : 2024-12-23
Valid Till : 2027-01-24
Written Confirmation Number : WC-0158
Address of the Firm :

Date of Issue : 2025-12-24
Valid Till : 2028-11-09
Written Confirmation Number : WC-0013
Address of the Firm :
Registrant Name : Sam-O 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

Registrant Name : Donghwa Pharmaceutical Co., Ltd.
Registration Date : 2011-06-30
Registration Number : 20110630-130-H-139-30
Manufacturer Name : Glochem Industries Private Limited
Manufacturer Address : Survey Nos. 174 to 176, IDA Bollaram, Jinnaram Mandal, Sangareddy District-502 325, Telangana State, India

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 Plant ①] Abhinandan Rasayan Pvt.@[Starting Material (Phthaloyl Amlodipine) Manufacturing Plant ②] 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


Registrant Name : Dongkwang Pharmaceutical Co., Ltd.
Registration Date : 2011-06-15
Registration Number : 20110414-130-H-48-19(2)
Manufacturer Name : Unichem Laboratories Ltd.@[Starting Material (Phthaloyl Amlodipine) Manufacturing Plant ①] Abhinandan Rasayan Pvt.@[Starting Material (Phthaloyl Amlodipine) Manufacturing Plant ②] 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



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PharmaCompass offers a list of Amlodipine Maleate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Amlodipine Maleate manufacturer or Amlodipine Maleate supplier for your needs.
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A Amlor manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amlor, including repackagers and relabelers. The FDA regulates Amlor manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amlor 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 Amlor manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Amlor supplier is an individual or a company that provides Amlor active pharmaceutical ingredient (API) or Amlor finished formulations upon request. The Amlor suppliers may include Amlor API manufacturers, exporters, distributors and traders.
click here to find a list of Amlor suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
We have 13 companies offering Amlor
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