01 1Amoli Organics (A Division of Umedica Laboratories Pvt. Ltd.)
02 1Hanseochem Co., Ltd.
03 1Hwail Pharmaceutical Co., Ltd. [Second Law Pharmaceutical Manufacturing Company] Henan Dongtai Pharmaceutical Co., Ltd.
04 3Jiangxi Synergy Pharmaceutical Co., Ltd
05 12Jiangxi Synergy Pharmaceutical Co.,Ltd
06 1Jiangxi Synergy Pharmaceutical Co.,Ltd.
07 1Korea Biochem Pharmaceutical Co., Ltd. @[(Article 4) Raw Material Manufacturer] Henan Dongtai Pharmaceutical Co., Ltd._x000D_ @Magma Industries Ltd
08 1Korea United Pharmaceuticals
09 1Kyungdong Pharmaceutical Co., Ltd.
10 1Polaris AI Pharma Co., Ltd.
11 1Ranke quimica, SA
12 1Richter Themis Medicare (I) Pvt. Ltd.
13 1Samoh Pharmaceutical Co., Ltd.
14 1Shin Poong Pharmaceutical Co., Ltd.
15 1Touhou FTL
16 1Zhejiang Yongning Pharmaceutical Factory
17 1[Second Law Producer] IT Chem Co., Ltd. @ Hanmi Precision Chemical Co., Ltd.
01 1Ace Biopharm Co., Ltd.
02 1Ankuk Pharmaceutical Co., Ltd.
03 1Base Farm Co., Ltd.
04 1Daeshin Pharmaceutical Co., Ltd.
05 2Daewoong Pharmaceutical Co., Ltd.
06 1Dongbang FTL Co., Ltd.
07 1Hanmi Precision Chemical Co., Ltd.
08 1Hanseochem Co., Ltd.
09 1Hansol Pharma Co., Ltd.
10 1Hanyoung Farm Co., Ltd.
11 1Hiple Co., Ltd.
12 2Hwail Pharmaceutical Co., Ltd.
13 1KR Pharm Co., Ltd.
14 1Korea Biochem Pharmaceutical Co., Ltd.
15 2Korea United Pharmaceutical Co., Ltd.
16 1Kyungdong Pharmaceutical Co., Ltd.
17 1Masung LS Co., Ltd.
18 1Mothers Pharmaceutical Co., Ltd.
19 1Myungmoon Pharmaceutical Co., Ltd.
20 1Narsha Farm Co., Ltd.
21 1Pharmapia Co., Ltd.
22 1Polaris AI Pharma Co., Ltd.
23 1Samoh Pharmaceutical Co., Ltd.
24 1Shin Poong Pharmaceutical Co., Ltd.
25 1Shinil Pharmaceutical Co., Ltd.
26 1Sungwoo Chemical Co., Ltd.
27 1Toru Corporation
01 30Aceclofenac
01 17China
02 2India
03 9South Korea
04 1Spain
05 1Uzbekistan
Registrant Name : Hiple Co., Ltd.
Registration Date : 2016-04-05
Registration Number : 20160405-31-C-353-21
Manufacturer Name : Amoli Organics (A Division o...
Manufacturer Address : Plot No. 322/4, 40 Shed Area, GIDC Vapi-396 195, Gujarat State, India
Registrant Name : Mothers Pharmaceutical Co., Ltd.
Registration Date : 2024-07-17
Registration Number : 20120905-31-C-301-18(18)
Manufacturer Name : Jiangxi Synergy Pharmaceutic...
Manufacturer Address : Jiangxi Fengxin Industrial Park, Fengxin, 330700, Jiangxi Province,PR China
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2020-06-29
Registration Number : 20120905-31-C-301-18(16)
Manufacturer Name : Jiangxi Synergy Pharmaceutic...
Manufacturer Address : Jiangxi Fengxin Industrial Park, Fengxin, 330700, Jiangxi Province, PR China
Registrant Name : Narsha Farm Co., Ltd.
Registration Date : 2024-06-28
Registration Number : 20120905-31-C-301-18(17)
Manufacturer Name : Jiangxi Synergy Pharmaceutic...
Manufacturer Address : Jiangxi Fengxin Industrial Park, Fengxin, 330700, Jiangxi Province,PR China
Registrant Name : Shinil Pharmaceutical Co., Ltd.
Registration Date : 2016-09-21
Registration Number : 20120905-31-C-301-18(12)
Manufacturer Name : Jiangxi Synergy Pharmaceutic...
Manufacturer Address : Jiangxi Fengxin Industrial Park, Fengxin, 330700, Jiangxi Province,PR China
Registrant Name : Toru Corporation
Registration Date : 2019-12-16
Registration Number : 20120905-31-C-301-18(15)
Manufacturer Name : Jiangxi Synergy Pharmaceutic...
Manufacturer Address : Jiangxi Fengxin Industrial Park, Fengxin, 330700, Jiangxi Province,PR China
Registrant Name : Ankuk Pharmaceutical Co., Ltd.
Registration Date : 2016-07-06
Registration Number : 20120905-31-C-301-18(11)
Manufacturer Name : Jiangxi Synergy Pharmaceutic...
Manufacturer Address : Jiangxi Fengxin Industrial Park, Fengxin, 330700, Jiangxi Province, PR China
Registrant Name : KR Pharm Co., Ltd.
Registration Date : 2018-01-16
Registration Number : 20120905-31-C-301-18(13)
Manufacturer Name : Jiangxi Synergy Pharmaceutic...
Manufacturer Address : Jiangxi Fengxin Industrial Park, Fengxin, 330700, Jiangxi Province, PR China
Registrant Name : Hanyoung Farm Co., Ltd.
Registration Date : 2019-09-30
Registration Number : 20120905-31-C-301-18(14)
Manufacturer Name : Jiangxi Synergy Pharmaceutic...
Manufacturer Address : Jiangxi Fengxin Industrial Park, Fengxin, 330700, Jiangxi Province, PR China
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2014-09-12
Registration Number : 20120905-31-C-301-18(9)
Manufacturer Name : Jiangxi Synergy Pharmaceutic...
Manufacturer Address : Jiangxi Fengxin Industrial Park, Fengxin, 330700, Jiangxi Province, China
A Biofenac manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Biofenac, including repackagers and relabelers. The FDA regulates Biofenac manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Biofenac 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 Biofenac manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Biofenac supplier is an individual or a company that provides Biofenac active pharmaceutical ingredient (API) or Biofenac finished formulations upon request. The Biofenac suppliers may include Biofenac API manufacturers, exporters, distributors and traders.
click here to find a list of Biofenac 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 Biofenac Drug Master File in Korea (Biofenac KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Biofenac. The MFDS reviews the Biofenac KDMF as part of the drug registration process and uses the information provided in the Biofenac KDMF to evaluate the safety and efficacy of the drug.
After submitting a Biofenac 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 Biofenac API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Biofenac suppliers with KDMF on PharmaCompass.
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