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

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Chong Kun Dang Co., Ltd.
2013-04-05
20080128-30-A-216-13(3)
Centrient Pharmaceuticals...
India
Bhai Mohan Singh Nagar, T...
Centrient Pharmaceuticals

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Penmix Co., Ltd.
2011-06-15
20080128-30-A-216-13(1)
Centrient Pharmaceuticals...
India
Bhai Mohan Singh Nagar, T...
Centrient Pharmaceuticals

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Yuhan Corporation
2015-05-22
20080128-30-A-216-13(4)
Centrient Pharmaceuticals...
India
Bhai Mohan Singh Nagar, T...
Centrient Pharmaceuticals

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Korea United Pharmaceutical Co., Ltd.
2011-08-19
20080128-30-A-216-13(2)
Centrient Pharmaceuticals...
India
Bhai Mohan Singh Nagar, T...
Centrient Pharmaceuticals

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Ilsung Pharmaceutical Co., Ltd.
2023-03-30
20080128-30-A-216-13(6)
Centrient Pharmaceuticals...
India
Bhai Mohan Singh Nagar, T...
Centrient Pharmaceuticals

Iran Expo

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Boryeong Co., Ltd.
2021-01-14
20080128-30-A-216-13(5)
Centrient Pharmaceuticals...
India
Bhai Mohan Singh Nagar, T...
Centrient Pharmaceuticals

Iran Expo

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Aging Life Science Co., Ltd.
2008-01-28
20080128-30-A-216-13
Centrient Pharmaceuticals...
India
Bhai Mohan Singh Nagar, T...
Centrient Pharmaceuticals

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Seongui Bio Co., Ltd.
2017-06-14
20170614-30-A-328-22
Antibiotics De Leon SLU
Spain
Avda, Antibioticos 59-61,...
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Kosha Bio Co., Ltd.
2018-04-09
20050915-30-A-168-12(1)
AUROBINDO PHARMA LTD.
India
Unit-V plot NO. 79-91, Ch...
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Korea United Pharmaceutical Co., Ltd.
2005-09-15
20050915-30-A-168-12
AUROBINDO PHARMA LTD.
India
Unit-V plot No. 79-91, Ch...
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Boryeong Co., Ltd.
2011-10-14
20050831-30-A-71-10(1)
CSPC Zhongnuo Pharmaceuti...
China
No. 47 Fengshou Road Shij...
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Samo Pharmaceutical Co., Ltd.
2012-10-11
20050831-30-A-71-10(4)
CSPC Zhongnuo Pharmaceuti...
China
No. 47 Fengshou Road Shij...
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Daewoong Bio Co., Ltd.
2012-10-05
20050831-30-A-71-10(3)
CSPC Zhongnuo Pharmaceuti...
China
No. 47 Fengshou Road Shij...
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Aging Life Science Co., Ltd.
2005-08-31
20050831-30-A-69-08
Deretil S.A.
Spain
Villaricos, s/n 04618 Cue...
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Ilsung Pharmaceutical Co., Ltd.
2011-10-28
20050831-30-A-64-05(1)
Beecham Pharmaceuticals (...
Singapore
38 Quality Road Jurong In...
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GlaxoSmithKline Co., Ltd.
2005-08-31
20050831-30-A-64-05
Beecham Pharmaceuticals (...
Singapore
38 Quality Road Jurong In...
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Huseed Co., Ltd.
2021-11-24
20150706-30-A-307-20(8)
Inner Mongolia Changsheng...
China
Industry Zone, Tuoketuo, ...
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Kookjeon Pharmaceutical Co., Ltd.
2017-01-17
20150706-30-A-307-20(3)
Inner Mongolia Changsheng...
China
Industry Zone, Tuoketuo, ...
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RH Biopharm Co., Ltd.
2015-07-06
20150706-30-A-307-20
Inner Mongolia Changsheng...
China
Industry Zone, Tuoketuo, ...
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Chong Kun Dang Co., Ltd.
2017-08-03
20150706-30-A-307-20(5)
Inner Mongolia Changsheng...
China
Industry Zone, Tuoketuo, ...
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Inist Farm Co., Ltd.
2016-09-01
20150706-30-A-307-20(2)
Inner Mongolia Changsheng...
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Industry Zone, Tuoketuo, ...
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Boryeong Co., Ltd.
2017-07-27
20150706-30-A-307-20(4)
Inner Mongolia Changsheng...
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Industry Zone, Tuoketuo, ...
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KR Farm Co., Ltd.
2018-02-02
20150706-30-A-307-20(7)
Inner Mongolia Changsheng...
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Industry Zone, Tuoketuo, ...
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Daewoong Bio Co., Ltd.
2016-08-04
20150706-30-A-307-20(1)
Inner Mongolia Changsheng...
China
Industry Zone, Tuoketuo, ...
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Hwail Pharmaceutical Co., Ltd.
2018-01-11
20150706-30-A-307-20(6)
Inner Mongolia Changsheng...
China
Industry Zone, Tuoketuo, ...
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Shinpoong Pharmaceutical Co., Ltd.
2011-12-09
20050831-30-A-59-01(5)
Sandoz Industrial Product...
Spain
Ctra. Granollers - Carded...
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Penmix Co., Ltd.
2011-11-11
20050831-30-A-59-01(2)
Sandoz Industrial Product...
Spain
Ctra.Granollers a Cardede...
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Yuhan Corporation
2011-11-11
20050831-30-A-59-01(1)
Sandoz Industrial Product...
Spain
Ctra. Granollers a Carded...
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Chong Kun Dang Co., Ltd.
2014-08-27
20050831-30-A-59-01(8)
Sandoz Industrial Product...
Spain
Ctra. Granollers a Carded...
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Geonil Pharmaceutical Co., Ltd.
2005-08-31
20050831-30-A-59-01
Sandoz Industrial Product...
Spain
Ctra.Granollers a Cardede...
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Boryeong Co., Ltd.
2011-12-15
20050831-30-A-59-01(6)
Sandoz Industrial Product...
Spain
Ctra.Granollers a Cardede...
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Masung LS Co., Ltd.
2020-07-07
20200707-30-A-341-24
Sinopharm Weiqida Pharmac...
China
High-tech Industrial Zone...
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Masung LS Co., Ltd.
2019-11-21
20191121-30-A-353-23
Sinopharm Weiqida Pharmac...
China
High-tech Industrial Zone...
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Daewoong Bio Co., Ltd.
2020-06-23
20151218-30-A-314-21(2)
The United Laboratories(I...
China
Economy & Technology Park...
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Seongui Bio Co., Ltd.
2015-12-18
20151218-30-A-314-21
The United Laboratoried (...
China
Economy & Technology Park...
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Seongui Bio Co., Ltd.
2012-06-08
20101130-30-A-237-16(2)
Zhuhai United Laboratorie...
China
No.2428, Anji Road, Sanza...
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Chong Kun Dang Co., Ltd.
2014-11-06
20101130-30-A-237-16(7)
Zhuhai United Laboratorie...
China
No.2428, Anji Road, Sanza...
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Penmix Co., Ltd.
2010-11-30
20101130-30-A-237-16
Zhuhai United Laboratorie...
China
No.2428, Anji Road, Sanza...
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Boryeong Co., Ltd.
2012-12-21
20101130-30-A-237-16(6)
Zhuhai United Laboratorie...
China
No.2428, Anji Road, Sanza...
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Inist Farm Co., Ltd.
2015-01-27
20101130-30-A-237-16(8)
Zhuhai United Laboratorie...
China
No.2428, Anji Road, Sanza...
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  • TABLET;ORAL - 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • FOR SUSPENSION;ORAL - 125MG/5ML;EQ 31.25MG BASE/5ML
  • FOR SUSPENSION;ORAL - 250MG/5ML;EQ 62.5MG BASE/5ML
  • TABLET;ORAL - 875MG;EQ 125MG BASE
  • FOR SUSPENSION;ORAL - 200MG/5ML;EQ 28.5MG BASE/5ML
  • FOR SUSPENSION;ORAL - 400MG/5ML;EQ 57MG BASE/5ML
  • TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • FOR SUSPENSION;ORAL - 600MG/5ML;EQ 42.9MG BASE/5ML
  • CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL - 500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • FOR SUSPENSION;ORAL - 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • FOR SUSPENSION;ORAL - 400MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 62.5MG BASE
  • TABLET, EXTENDED RELEASE;ORAL - 775MG
  • CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Looking for 61336-70-7 / Amoxicillin Trihydrate API manufacturers, exporters & distributors?

Amoxicillin Trihydrate manufacturers, exporters & distributors 1

47

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

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

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

API | Excipient name

Amoxicillin Trihydrate

Synonyms

61336-70-7, Larotid, Polymox, Trimox, Utimox, Wymox

Cas Number

61336-70-7

Unique Ingredient Identifier (UNII)

804826J2HU

About Amoxicillin Trihydrate

A broad-spectrum semisynthetic antibiotic similar to AMPICILLIN except that its resistance to gastric acid permits higher serum levels with oral administration.

Amoxicillin Manufacturers

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

Amoxicillin Suppliers

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

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

Amoxicillin KDMF

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

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

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

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

Amoxicillin Manufacturers | Traders | Suppliers

Amoxicillin 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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