Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
01 2Bal Pharma Limited
02 1Almirall Farmaceuticas Industries, SA@Ranke Quimica, SA_x000D_ (Micronized Ebastin Manufacturing Plant)
03 1Estech Pharma Co., Ltd.
04 1RANKE QUIMICA, SA
05 1Ranke Quimica, SA
06 1Yuil Farm Tech Co., Ltd.
01 1Aging Life Science Co., Ltd.
02 3Boryeong Co., Ltd.
03 1Kukjeon Pharmaceutical Co., Ltd.
04 1Polaris AI Pharma Co., Ltd.
05 1Yuil Farm Tech Co., Ltd.
01 7Ebastin
01 2India
02 1Japan
03 1South Korea
04 3Spain
Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2019-02-15
Registration Number : 20120824-156-I-42-01(1)
Manufacturer Name : Bal Pharma Limited
Manufacturer Address : 61-B, Bommasandra Industrial Area Bangalore – 560 099
Bal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2012-08-24
Registration Number : 20120824-156-I-42-01
Manufacturer Name : Bal Pharma Limited
Manufacturer Address : 61-B, Bommasandra Industrial Area Bangalore – 560 099
Registrant Name : Boryeong Co., Ltd.
Registration Date : 2013-08-21
Registration Number : 20130821-156-I-323-05
Manufacturer Name : Almirall Farmaceuticas Indus...
Manufacturer Address : Ctra. de Martorell 41-61 08740 Sant Andreu de la Barca (Barcelona), Spain@Ctra. C-35,...
Registrant Name : Boryeong Co., Ltd.
Registration Date : 2013-07-25
Registration Number : 20130725-156-I-254-03
Manufacturer Name : Ranke Quimica, SA
Manufacturer Address : Ctra. C-35, Km 58.85, Sant Celoni 08470 Barcelona, Spain
Registrant Name : Boryeong Co., Ltd.
Registration Date : 2013-07-25
Registration Number : 20130725-156-I-308-04
Manufacturer Name : RANKE QUIMICA, SA
Manufacturer Address : Ctra. Martorell, 41-61 08740-Sant Andreu de la Barca Barcelona-Spain
Registrant Name : Polaris AI Pharma Co., Ltd.
Registration Date : 2012-11-29
Registration Number : 20121129-156-I-224-02
Manufacturer Name : Estech Pharma Co., Ltd.
Manufacturer Address : (445-938) 25 Balan Industrial Complex-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do
Registrant Name : Yuil Farm Tech Co., Ltd.
Registration Date : 2013-05-10
Registration Number : 20130510-156-I-338-03
Manufacturer Name : Yuil Farm Tech Co., Ltd.
Manufacturer Address : 3 Mulmi-gil, Iwol-myeon, Jincheon-gun, Chungcheongbuk-do
A Ebastine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ebastine, including repackagers and relabelers. The FDA regulates Ebastine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ebastine 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 Ebastine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ebastine supplier is an individual or a company that provides Ebastine active pharmaceutical ingredient (API) or Ebastine finished formulations upon request. The Ebastine suppliers may include Ebastine API manufacturers, exporters, distributors and traders.
click here to find a list of Ebastine 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 Ebastine Drug Master File in Korea (Ebastine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ebastine. The MFDS reviews the Ebastine KDMF as part of the drug registration process and uses the information provided in the Ebastine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ebastine 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 Ebastine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ebastine suppliers with KDMF on PharmaCompass.
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