01 1Apothecon Pharmaceuticals Pvt. Ltd.
02 1Fresenius Kabi Oncology Ltd.
03 1Qilu Pharmaceutical Co., Ltd
04 1Shandong Anhong Pharmaceutical Co., Ltd. (formerly Qilu Antibiotics (Linyi) Pharmaceutical Co., Ltd.)
05 1Shandong Anhong Pharmaceutical Co.,Ltd
01 1Ace Biopharm Co., Ltd.
02 1Fresenius Kabi Korea Co., Ltd.
03 1Hiple Co., Ltd.
04 2Insung Trading Co., Ltd.
01 2Ropivacaine hydrochloride
02 3Ropivacaine hydrochloride hydrate
01 3China
02 1India
03 1Sweden
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2023-04-06
Registration Number : 20230406-210-J-1291
Manufacturer Name : Apothecon Pharmaceuticals Pv...
Manufacturer Address : Plot No. 1134, 1135, 1136, 1137, 1143B, 1144A & 1144B, 1138A & 1138B, Pandra-Jambusar...
Registrant Name : Fresenius Kabi Korea Co., Ltd.
Registration Date : 2022-05-04
Registration Number : 20220504-210-J-1286
Manufacturer Name : Fresenius Kabi Oncology Ltd.
Manufacturer Address : D-35, Industrial Area, Kalyani, Dist Nadia, West Bengal, INDIA
Ropivacaine hydrochloride hydrate
Registrant Name : Insung Trading Co., Ltd.
Registration Date : 2020-09-15
Registration Number : 20200915-210-J-543
Manufacturer Name : Qilu Pharmaceutical Co., Ltd
Manufacturer Address : No. 23999 Gong Ye Bei Road, Jinan, Shandong Province, 250100, PRChina
Ropivacaine hydrochloride hydrate
Registrant Name : Insung Trading Co., Ltd.
Registration Date : 2020-08-18
Registration Number : 20200818-210-J-676
Manufacturer Name : Shandong Anhong Pharmaceutic...
Manufacturer Address : No.29 Huayuan street Linyi County, Dezhou, Shandong, China
Ropivacaine hydrochloride hydrate
Registrant Name : Hiple Co., Ltd.
Registration Date : 2021-03-12
Registration Number : 20200818-210-J-676(1)
Manufacturer Name : Shandong Anhong Pharmaceutic...
Manufacturer Address : No.29 Huayuan Street Linyi County, Dezhou, Shandong, China
A Naropin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Naropin, including repackagers and relabelers. The FDA regulates Naropin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Naropin 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 Naropin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Naropin supplier is an individual or a company that provides Naropin active pharmaceutical ingredient (API) or Naropin finished formulations upon request. The Naropin suppliers may include Naropin API manufacturers, exporters, distributors and traders.
click here to find a list of Naropin 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 Naropin Drug Master File in Korea (Naropin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Naropin. The MFDS reviews the Naropin KDMF as part of the drug registration process and uses the information provided in the Naropin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Naropin 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 Naropin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Naropin suppliers with KDMF on PharmaCompass.
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