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List of Korea Drug Master Files (KDMF) for Azithromycin Active Pharmaceutical Ingredient submitted to the Review Authority in Korea and listed on PharmaCompass.com

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Kyungdong Pharmaceutical Co., Ltd.
2022-06-23
20130503-191-I-145-06(1)
Alembic Pharmaceuticals L...
India
Vill. Panelav, POTajpura,...
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Sangjin Trading Co., Ltd.
2013-05-03
20130503-191-I-145-06
Alembic Pharmaceuticals L...
India
Vill. Panelav, POTajpura,...
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Pfizer Pharmaceuticals Korea Co., Ltd.
2020-10-14
20201014-191-I-595-07
Pfizer Asia Manufacturing...
U.S.A
31 Tuas South Avenue 6 Si...
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Pfizer Pharmaceuticals Korea Co., Ltd.
2012-09-20
20120920-191-I-72-03
Pfizer Ireland Pharmaceut...
Ireland
Ringaskiddy API Plant, PO...
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Pfizer Pharmaceuticals Korea Co., Ltd.
2012-12-20
20121220-191-I-73-04
Pfizer Pharmaceuticals LL...
Puerto Rico
Barceloneta, PR 00617
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Samo Pharmaceutical Co., Ltd.
2023-06-02
20230602-191-I-654-08
PLIVA Croatia Ltd@ABBVIE ...
Croatia
Prudnicka cesta 54, Savsk...
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Ace Biopharm Co., Ltd.
2013-04-10
20130123-191-I-119-05(1)
Zhejiang Guobang Pharmace...
China
No.6, Weiwu Road, Hangzho...
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Aging Life Science Co., Ltd.
2019-05-22
20130123-191-I-119-05(5)
Zhejiang Guobang Pharmace...
China
No.6, Weiwu Road, Hangzho...
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Hwail Pharmaceutical Co., Ltd.
2015-08-13
20130123-191-I-119-05(2)
Zhejiang Guobang Pharmace...
China
No. 6, Weiwu Road, Hangzh...
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Kolon Pharmaceutical Co., Ltd.
2015-07-14
20130123-191-I-119-05(3)
Zhejiang Guobang Pharmace...
China
No. 6, Weiwu Road, Hangzh...
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Samil Pharmaceutical Co., Ltd.
2016-02-25
20130123-191-I-119-05(4)
Zhejiang Guobang Pharmace...
China
No.6, Weiwu Road, Hangzho...
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Kyungdong Pharmaceutical Co., Ltd.
2019-08-02
20130123-191-I-119-05(6)
Zhejiang Guobang Pharmace...
China
No.6, Weiwu Road, Hangzho...
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Sangjin Trading Co., Ltd.
2013-01-23
20130123-191-I-119-05
Zhejiang Guobang Pharmace...
China
No. 6, Weiwu Road, Hangzh...
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  • FOR SUSPENSION;ORAL - EQ 1GM BASE/PACKET
  • FOR SUSPENSION;ORAL - EQ 100MG BASE/5ML
  • FOR SUSPENSION;ORAL - EQ 200MG BASE/5ML
  • TABLET;ORAL - EQ 250MG BASE
  • TABLET;ORAL - EQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • INJECTABLE;INJECTION - EQ 500MG BASE/VIAL
  • TABLET;ORAL - EQ 500MG BASE
  • FOR SUSPENSION, EXTENDED RELEASE;ORAL - EQ 2GM BASE/BOT

Looking for 83905-01-5 / Azithromycin API manufacturers, exporters & distributors?

Azithromycin manufacturers, exporters & distributors 1

64

PharmaCompass offers a list of Azithromycin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Azithromycin manufacturer or Azithromycin supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Azithromycin manufacturer or Azithromycin supplier.

PharmaCompass also assists you with knowing the Azithromycin API Price utilized in the formulation of products. Azithromycin API Price is not always fixed or binding as the Azithromycin Price is obtained through a variety of data sources. The Azithromycin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Azithromycin

Synonyms

Zithromax, 83905-01-5, Sumamed, Hemomycin, Azasite, Zitromax

Cas Number

83905-01-5

Unique Ingredient Identifier (UNII)

J2KLZ20U1M

About Azithromycin

A semi-synthetic macrolide antibiotic structurally related to ERYTHROMYCIN. It has been used in the treatment of Mycobacterium avium intracellulare infections, toxoplasmosis, and cryptosporidiosis.

Azithromycin Manufacturers

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.

Azithromycin Suppliers

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.

Azithromycin KDMF

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.

Azithromycin Manufacturers | Traders | Suppliers

Azithromycin Manufacturers, Traders, Suppliers 1
42

We have 4 companies offering Azithromycin

Get in contact with the supplier of your choice:

  1. Alembic Pharmaceuticals Limited
  2. Pfizer Inc
  3. Pliva Hrvatska
  4. Zhejiang Guobang Pharmaceutical
Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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