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01 2Ami Lifesciences Private Limited
02 1Bidachem SpA
03 1Dongwha Pharmaceutical Co., Ltd.
04 2Hwail Pharmaceutical Co., Ltd.
05 1PEN TSAO CHEMICAL INDUSTRY LTD.
06 1Shilpa Medicare Limited
07 5Shilpa Pharma Lifesciences Limited
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01 1Aging Life Science Co., Ltd.
02 1Daeshin Pharmaceutical Co., Ltd.
03 1Dongwha Pharmaceutical Co., Ltd.
04 1Hanmi Pharmaceutical Co., Ltd.
05 1Hiple Co., Ltd.
06 2Hwail Pharmaceutical Co., Ltd.
07 2IMCD Korea Co., Ltd.
08 1Kukjeon Pharmaceutical Co., Ltd.
09 2Opella Healthcare Korea Co., Ltd.
10 1Pharmapia Co., Ltd.
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01 13Ambroxol hydrochloride
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01 1China
02 8India
03 1Italy
04 3South Korea
Registrant Name : Hanmi Pharmaceutical Co., Ltd.
Registration Date : 2023-02-27
Registration Number : 20221028-45-B-470-06(1)
Manufacturer Name : Ami Lifesciences Private Lim...
Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Di...
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2022-10-28
Registration Number : 20221028-45-B-470-06
Manufacturer Name : Ami Lifesciences Private Lim...
Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Di...
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2014-10-20
Registration Number : 20050831-45-B-116-03(1)
Manufacturer Name : Hwail Pharmaceutical Co., Lt...
Manufacturer Address : Gyeonggi-do Hwaseong-si Hyangnam-eup Yakjakgongdan 3-gil 57_x000D_
Registrant Name : IMCD Korea Co., Ltd.
Registration Date : 2005-08-31
Registration Number : 20050831-45-B-112-01
Manufacturer Name : PEN TSAO CHEMICAL INDUSTRY L...
Manufacturer Address : 2 Tie Li Road, Wu Song, shanghai 200940, China
Registrant Name : Daeshin Pharmaceutical Co., Ltd.
Registration Date : 2011-08-05
Registration Number : 20050915-45-B-206-05(2)
Manufacturer Name : Shilpa Pharma Lifesciences L...
Manufacturer Address : 1A & 1A'P', 1B, 2, 2A, 2B, 3A to 3E, 4A, 5A, 4B & 5B Deosugur Industrial Area, Deosug...
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2021-04-23
Registration Number : 20050915-45-B-206-05(8)
Manufacturer Name : Shilpa Pharma Lifesciences L...
Manufacturer Address : 1A & 1A'P', 1B, 2, 2A, 2B, 3A to 3E, 4A, 5A, 4B & 5B Deosugur Industrial Area, Deosug...
Registrant Name : Hiple Co., Ltd.
Registration Date : 2016-07-29
Registration Number : 20050915-45-B-206-05(5)
Manufacturer Name : Shilpa Pharma Lifesciences L...
Manufacturer Address : 1A & 1A'P', 1B, 2, 2A, 2B, 3A to 3E, 4A, 5A, 4B & 5B Deosugur Industrial Area, Deosug...
Registrant Name : IMCD Korea Co., Ltd.
Registration Date : 2005-09-15
Registration Number : 20050915-45-B-206-05
Manufacturer Name : Shilpa Pharma Lifesciences L...
Manufacturer Address : 1A & 1A'P', 1B, 2, 2A, 2B, 3A to 3E, 4A, 5A, 4B & 5B Deosugur Industrial Area, Deosug...
Registrant Name : Opella Healthcare Korea Co., Ltd.
Registration Date : 2020-04-01
Registration Number : 20050915-45-B-206-05(7)
Manufacturer Name : Shilpa Medicare Limited
Manufacturer Address : 1A & 1A'P', 1B, 2, 2A, 2B, 3A to 3E, 4A, 5A, 4B & 5B Deosugur Industrial Area, Deosug...
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2020-03-25
Registration Number : 20050915-45-B-206-05(6)
Manufacturer Name : Shilpa Pharma Lifesciences L...
Manufacturer Address : 1A & 1A'P', 1B, 2, 2A, 2B, 3A to 3E, 4A, 5A, 4B & 5B Deosugur Industrial Area, Deosug...
A Ambroxol Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ambroxol Hydrochloride, including repackagers and relabelers. The FDA regulates Ambroxol Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ambroxol Hydrochloride 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 Ambroxol Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ambroxol Hydrochloride supplier is an individual or a company that provides Ambroxol Hydrochloride active pharmaceutical ingredient (API) or Ambroxol Hydrochloride finished formulations upon request. The Ambroxol Hydrochloride suppliers may include Ambroxol Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Ambroxol Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Ambroxol Hydrochloride Drug Master File in Korea (Ambroxol Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ambroxol Hydrochloride. The MFDS reviews the Ambroxol Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Ambroxol Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ambroxol Hydrochloride KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Ambroxol Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ambroxol Hydrochloride suppliers with KDMF on PharmaCompass.
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