01 2AUROBINDO PHARMA LTD.
02 1Akums Lifesciences Limited
03 1Apitoria Pharma Private Limited
04 3Covalent Laboratories Pvt. Ltd.
05 1Hanmi Precision Chemical Co., Ltd.
06 1Orchid Chemicals & Pharmaceuticals Ltd.
07 1Orchid Chemicals & Pharmaceuticals Ltd.,
08 4Orchid Pharma Limited
09 1Orchid Pharma Ltd.
10 1Qilu Antibiotics Pharmaceutical Co., Ltd
01 1Dong-A ST Co., Ltd.
02 1Hanareum Farm Co., Ltd.
03 1Hanmi Precision Chemical Co., Ltd.
04 2International Pharmaceutical Co., Ltd.
05 3KR Pharm Co., Ltd.
06 2Samoh Pharmaceutical Co., Ltd.
07 2Seongi Bio Co., Ltd.
08 1Shin Poong Pharmaceutical Co., Ltd.
09 1Sungwoo Chemical Co., Ltd.
10 2Withers Pharmaceutical Co., Ltd.
01 1Sepixim
02 15Septic acid hydrochloride
01 1China
02 2Egypt
03 12India
04 1South Korea
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2022-01-26
Registration Number : 20220126-26-A-370-11
Manufacturer Name : Apitoria Pharma Private Limi...
Manufacturer Address : Sy Nos. 52, 53, 58, 59, 61 to 78, 127 & 128, Pydibhimavaram Village & 1, 2, 4 to 9, 1...
Registrant Name : International Pharmaceutical Co., Ltd.
Registration Date : 2015-08-11
Registration Number : 20050831-26-A-57-04(3)
Manufacturer Name : AUROBINDO PHARMA LTD.
Manufacturer Address : Plot No. 79-91, IDA Chemical Zone, Pashamylaram, Medak (District) Andhra Pradesh, IND...
Registrant Name : Withers Pharmaceutical Co., Ltd.
Registration Date : 2016-08-09
Registration Number : 20130710-26-A-286-09(2)
Manufacturer Name : Covalent Laboratories Pvt. L...
Manufacturer Address : Sy.No.374, Gundla Machanoor Village, Hathnoor Mandal, Sangareddy District - 502 296, ...
Registrant Name : Hanareum Farm Co., Ltd.
Registration Date : 2016-06-09
Registration Number : 20130710-26-A-286-09(1)
Manufacturer Name : Covalent Laboratories Pvt. L...
Manufacturer Address : Sy.No.374, Gundla Machanoor Village, Hathnoor Mandal, Sangareddy District - 502 296, ...
Registrant Name : KR Pharm Co., Ltd.
Registration Date : 2013-07-10
Registration Number : 20130710-26-A-286-09
Manufacturer Name : Covalent Laboratories Pvt. L...
Manufacturer Address : Sy.No.374, Gundla Machanoor Village, Hathnoor Mandal, Sangareddy District - 502 296, ...
Registrant Name : International Pharmaceutical Co., Ltd.
Registration Date : 2012-05-18
Registration Number : 20050831-26-A-56-03(4)
Manufacturer Name : Orchid Chemicals & Pharmaceu...
Manufacturer Address : 138-149, SIDCO Industrial Estate, Alathur-603 110, Kancheepuram District, INDIA
Registrant Name : KR Pharm Co., Ltd.
Registration Date : 2012-04-06
Registration Number : 20050831-26-A-56-03(5)
Manufacturer Name : Orchid Pharma Ltd.
Manufacturer Address : Plot Nos. 121-128, 128A-133, 138-151, 159-164, SIDCO Industrial Estate, Alathur-603 1...
Registrant Name : Seongi Bio Co., Ltd.
Registration Date : 2022-05-31
Registration Number : 20050831-26-A-56-03(6)
Manufacturer Name : Orchid Pharma Limited
Manufacturer Address : Plot No's. 121-128, 128A-133, 138-151 & 159-164, SIDCO Industrial EstateAlathur, Kanc...
Registrant Name : Sungwoo Chemical Co., Ltd.
Registration Date : 2012-08-31
Registration Number : 20120831-26-A-269-08
Manufacturer Name : Akums Lifesciences Limited
Manufacturer Address : Village Sundhran, Post office Mubarikpur, Derabassi, District Sahibzada Ajit Singh Na...
Registrant Name : Seongi Bio Co., Ltd.
Registration Date : 2015-05-15
Registration Number : 20150515-26-A-318-10
Manufacturer Name : Qilu Antibiotics Pharmaceuti...
Manufacturer Address : No.849 Dongjia Town, Licheng District, Jinan, Shandong Province, China_x000D_
A Oroken manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oroken, including repackagers and relabelers. The FDA regulates Oroken manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oroken 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 Oroken manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Oroken supplier is an individual or a company that provides Oroken active pharmaceutical ingredient (API) or Oroken finished formulations upon request. The Oroken suppliers may include Oroken API manufacturers, exporters, distributors and traders.
click here to find a list of Oroken 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 Oroken Drug Master File in Korea (Oroken KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Oroken. The MFDS reviews the Oroken KDMF as part of the drug registration process and uses the information provided in the Oroken KDMF to evaluate the safety and efficacy of the drug.
After submitting a Oroken 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 Oroken API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Oroken suppliers with KDMF on PharmaCompass.
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