01 2Alembic Pharmaceuticals Limited (Unit-Ⅰ)
02 1PLIVA Croatia Ltd@ABBVIE INC@HEC Pharm Co., Ltd.@Anuh Pharma Ltd.
03 1Pfizer Asia Manufacturing Pte Ltd@[Erythromycin Manufacturing Plant ①]Abb Vie Inc@[Erythromycin Manufacturing Plant ②]HEC Pharm Co., Ltd@Pliva Croatia Ltd@Alembic Pharmaceuticals Limited
04 1Pfizer Ireland Pharmaceuticals
05 1Pfizer Pharmaceuticals LLC
06 6Zhejiang Guobang Pharmaceutical Co., Ltd.
01 1Ace Biopharm Co., Ltd.
02 1Aging Life Science Co., Ltd.
03 1Hwail Pharmaceutical Co., Ltd.
04 1Kolon Pharmaceutical Co., Ltd.
05 3Korea Pfizer Pharmaceutical Co., Ltd.
06 2Kyungdong Pharmaceutical Co., Ltd.
07 1Samoh Pharmaceutical Co., Ltd.
08 2Sangjin Corporation
01 10Azithromycin
02 2Azithromycin hydrate
01 6China
02 1Croatia
03 2India
04 3U.S.A
Registrant Name : Sangjin Corporation
Registration Date : 2013-05-03
Registration Number : 20130503-191-I-145-06
Manufacturer Name : Alembic Pharmaceuticals Limi...
Manufacturer Address : Vill. Panelav, POTajpura, Taluka-Halol, District- Panchmahal, Gujarat State, India-38...
Registrant Name : Kyungdong Pharmaceutical Co., Ltd.
Registration Date : 2022-06-23
Registration Number : 20130503-191-I-145-06(1)
Manufacturer Name : Alembic Pharmaceuticals Limi...
Manufacturer Address : Vill. Panelav, POTajpura, Taluka-Halol, District- Panchmahal, Gujarat State, India-38...
Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.
Registration Date : 2020-10-14
Registration Number : 20201014-191-I-595-07
Manufacturer Name : Pfizer Asia Manufacturing Pt...
Manufacturer Address : 31 Tuas South Avenue 6 Singapore 637578@[erythromycin manufacturing plant ①]1401 Sh...
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2023-06-02
Registration Number : 20230602-191-I-654-08
Manufacturer Name : PLIVA Croatia Ltd@ABBVIE INC...
Manufacturer Address : Prudnicka cesta 54, Savski Marof, 10291 Brdovec, Croatia@1401 Sheridan Road, North Ch...
Registrant Name : Sangjin Corporation
Registration Date : 2013-01-23
Registration Number : 20130123-191-I-119-05
Manufacturer Name : Zhejiang Guobang Pharmaceuti...
Manufacturer Address : No. 6, Wei wu Road, Hangzhou Gulf Shangyu Economic and Technical Development Zone, Zh...
Registrant Name : Kyungdong Pharmaceutical Co., Ltd.
Registration Date : 2019-08-02
Registration Number : 20130123-191-I-119-05(6)
Manufacturer Name : Zhejiang Guobang Pharmaceuti...
Manufacturer Address : No.6, Weiwu Road, Hangzhou Gulf Shangyu Industrial Zone, Zhejiang, China
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2013-04-10
Registration Number : 20130123-191-I-119-05(1)
Manufacturer Name : Zhejiang Guobang Pharmaceuti...
Manufacturer Address : No.6, Weiwu Road, Hangzhou Gulf Shangyu Economic and Technological Development Zone, ...
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2019-05-22
Registration Number : 20130123-191-I-119-05(5)
Manufacturer Name : Zhejiang Guobang Pharmaceuti...
Manufacturer Address : No.6, Weiwu Road, Hangzhou Gulf Shangyu Industrial Zone, Zhejiang, PR China
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2015-08-13
Registration Number : 20130123-191-I-119-05(2)
Manufacturer Name : Zhejiang Guobang Pharmaceuti...
Manufacturer Address : No. 6, Weiwu Road, Hangzhou Gulf Shangyu Industrial Zone, Zhejiang, China
Registrant Name : Kolon Pharmaceutical Co., Ltd.
Registration Date : 2015-07-14
Registration Number : 20130123-191-I-119-05(3)
Manufacturer Name : Zhejiang Guobang Pharmaceuti...
Manufacturer Address : No. 6, Wei wu Road, Hangzhou Gulf Shangyu Economic and Technological Development Zone...
A Azithromycin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Azithromycin, including repackagers and relabelers. The FDA regulates Azithromycin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Azithromycin 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 Azithromycin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Azithromycin supplier is an individual or a company that provides Azithromycin active pharmaceutical ingredient (API) or Azithromycin finished formulations upon request. The Azithromycin suppliers may include Azithromycin API manufacturers, exporters, distributors and traders.
click here to find a list of Azithromycin 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 Azithromycin Drug Master File in Korea (Azithromycin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Azithromycin. The MFDS reviews the Azithromycin KDMF as part of the drug registration process and uses the information provided in the Azithromycin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Azithromycin 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 Azithromycin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Azithromycin suppliers with KDMF on PharmaCompass.
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