Evonik Evonik

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

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API REF. PRICE (USD / KG)
130
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Europe

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SERVICES
Flag India
Digital Content Digital Content
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NA Not Available For Sales
JW Life Science Co., Ltd.
2011-03-31
20081128-102-F-2-04(1)
Dr. Reddy's Laboratories ...
India
Chemical Technical Operat...
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NA Not Available For Sales
Sangjin Trading Co., Ltd.
2008-11-28
20081128-102-F-2-04
Dr. Reddy's Laboratories ...
India
Chemical Technical Operat...
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Digital Content Digital Content
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NA Not Available For Sales
Hallym Pharmaceutical Co., Ltd.
2011-05-31
20081128-102-F-2-04(2)
Dr. Reddy's Laboratories ...
India
Chemical Technical Operat...
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Digital Content Digital Content
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Jeil Pharmaceutical Co., Ltd.
2008-09-30
20080930-102-F-6-02
Alfresa Fine Chemical Cor...
Japan
1-10-1, Mukaihama, Akita,...
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Digital Content Digital Content
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Wonpoong Pharmaceutical Co., Ltd.
2010-07-15
20100715-102-F-52-12
Aurobindo Pharma Limited
India
Unit-XI, block E, Pydibhi...
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Digital Content Digital Content
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UNUST Co., Ltd.
2011-03-31
20110331-102-F-58-13
Cipla Limited
India
Virgonagar Post, Old Madr...
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Ildong Pharmaceutical Co., Ltd.
2009-01-19
20090119-102-F-23-05
Ildong Pharmaceutical Co....
South Korea
53, Gongdan-ro 98beon-gil...
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Digital Content Digital Content
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Shinpoong Pharmaceutical Co., Ltd.
2010-02-11
20100211-102-F-55-09
Shinpoong Pharmaceutical ...
South Korea
7, Wonsi-ro, Danwon-gu, A...
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Flag Spain
Digital Content Digital Content
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Sungjin Exim Co., Ltd.
2012-08-06
20120806-102-F-70-15
Uquifa Mexico S.A. de CV
Mexico
Calle 37 Este No 126, CIV...
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Yuhan Chemical Co., Ltd.
2009-03-31
20090331-102-F-37-06
Yuhan Chemical Co., Ltd.
South Korea
45 Jiwon-ro, Danwon-gu, A...
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KR Farm Co., Ltd.
2010-06-30
20100630-102-F-54-11
Shangyu Jingxin Pharmaceu...
China
No. 31 Weisan Road, Hangz...
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Dongkwang Pharmaceutical Co., Ltd.
2018-06-25
20100630-102-F-54-11(5)
Shangyu Jingxin Pharmaceu...
China
No 31, Weisan Road, Zheji...
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Withers Pharmaceutical Co., Ltd.
2011-12-09
20100414-102-F-50-10(3)
Zhejiang East-asia Pharma...
China
Economic Development zone...
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Hwail Pharmaceutical Co., Ltd.
2009-09-24
20090924-102-F-40-07
Zhejiang Medicine Co., Lt...
China
98 East Xinchang Dadao Ro...
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HC Chemicals Co., Ltd.
2012-05-18
20100414-102-F-50-10(8)
Zhejiang East-asia Pharma...
China
Economic Development zone...
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Sungwoo Chemical Co., Ltd.
2011-10-28
20100414-102-F-50-10(2)
Zhejiang East-asia Pharma...
China
Economic Development zone...
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Pharmapia Co., Ltd.
2013-07-04
20100414-102-F-50-10(11)
Zhejiang East-asia Pharma...
China
Economic Development zone...
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Dongkwang Pharmaceutical Co., Ltd.
2014-09-01
20100414-102-F-50-10(14)
Zhejiang East-Asia Pharma...
China
Economic Development zone...
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Hwail Pharmaceutical Co., Ltd.
2011-06-15
20090924-102-F-40-07(1)
Zhejiang Medicine Co., Lt...
China
98 East Xinchang Dadao Ro...
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SG Biochem Co., Ltd.
2017-07-27
20100414-102-F-50-10(18)
Zhejiang East-asia Pharma...
China
Economic Development zone...
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Guju Pharmaceutical Co., Ltd.
2012-02-10
20100414-102-F-50-10(1)
Zhejiang East-asia Pharma...
China
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Daesin Pharmaceutical Co., Ltd.
2012-02-03
20100414-102-F-50-10(7)
Zhejiang East-asia Pharma...
China
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Hwail Pharmaceutical Co., Ltd.
2010-04-14
20100414-102-F-50-10
Zhejiang East-asia Pharma...
China
Economic Development zone...
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Kookjeon Pharmaceutical Co., Ltd.
2011-12-23
20100414-102-F-50-10(4)
Zhejiang East-asia Pharma...
China
Economic Development zone...
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Hiple Co., Ltd.
2016-07-06
20100414-102-F-50-10(17)
Zhejiang East-asia Pharma...
China
Economic Development zone...
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ENGCHEM Life Science Co., Ltd.
2008-10-31
20081031-102-F-21-03
ENGCHEM Life Science Co.,...
South Korea
59 Bio Valley-ro, Jecheon...
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  • TABLET;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SOLUTION/DROPS;OPHTHALMIC - 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SOLUTION/DROPS;OPHTHALMIC - 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SOLUTION;ORAL - 250MG/10ML

Looking for 100986-85-4 / Levofloxacin API manufacturers, exporters & distributors?

Levofloxacin manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Levofloxacin 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 Levofloxacin manufacturer or Levofloxacin supplier for your needs.

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

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

API | Excipient name

Levofloxacin

Synonyms

100986-85-4, Levaquin, Quixin, (-)-ofloxacin, Cravit, Iquix

Cas Number

100986-85-4

Unique Ingredient Identifier (UNII)

RIX4E89Y14

About Levofloxacin

The L-isomer of Ofloxacin.

Levofloxacin Manufacturers

A Levofloxacin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Levofloxacin, including repackagers and relabelers. The FDA regulates Levofloxacin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Levofloxacin 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 Levofloxacin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Levofloxacin Suppliers

A Levofloxacin supplier is an individual or a company that provides Levofloxacin active pharmaceutical ingredient (API) or Levofloxacin finished formulations upon request. The Levofloxacin suppliers may include Levofloxacin API manufacturers, exporters, distributors and traders.

click here to find a list of Levofloxacin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Levofloxacin KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Levofloxacin Drug Master File in Korea (Levofloxacin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Levofloxacin. The MFDS reviews the Levofloxacin KDMF as part of the drug registration process and uses the information provided in the Levofloxacin KDMF to evaluate the safety and efficacy of the drug.

After submitting a Levofloxacin 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 Levofloxacin API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Levofloxacin suppliers with KDMF on PharmaCompass.

Levofloxacin Manufacturers | Traders | Suppliers

Levofloxacin Manufacturers, Traders, Suppliers 1
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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