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List of Drug Master Files (KDMF) for Amoxicillin Sodium Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 Sandoz GmbH (4)

02 Sandoz Industrial Products, S.A. (4)

03 SmithKline Beecham Pharmaceuticals@[Starting material (amoxicillin trihydrate) manufacturer] Beecham Pharmaceuticals (Pte) Ltd (1)

04 Zhuhai United Laboratories Co., Ltd. (5)

05 Zhuhai United Laboratories Co., Ltd_x000D_ (1)

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01 Chong Kun Dang Co., Ltd. (2)

02 Daewoong Pharmaceutical Co., Ltd. (1)

03 GlaxoSmithKline Co., Ltd. (2)

04 Ilsung Pharmaceutical Co., Ltd. (1)

05 Penmix Co., Ltd. (3)

06 Samjin Pharmaceutical Co., Ltd. (2)

07 Seongui Bio Co., Ltd. (1)

08 Shinpoong Pharmaceutical Co., Ltd. (2)

09 Sungwoo Chemical Co., Ltd. (1)

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01 Amoxicillin Sodium (15)

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01 China (6)

02 Switzerland (8)

03 United Kingdom (1)

GSK

Contact Supplier
  • FDA
  • EDQM
  • WHO-GMP
URL Supplier Web Content
GlaxoSmithKline Co., Ltd.
2014-04-21
20140421-30-A-291-19
SmithKline Beecham Pharma...
United Kingdom
Clarendon Road, Worthing,...
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Shinpoong Pharmaceutical Co., Ltd.
2012-09-04
20101116-30-A-240-15(2)
Sandoz GmbH
Austria
Biochemiestraße 10, A-62...
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Ilsung Pharmaceutical Co., Ltd.
2012-02-03
20101116-30-A-240-15(1)
Sandoz GmbH
Austria
Biochemiestrasse 10, A-62...
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Penmix Co., Ltd.
2013-05-02
20101116-30-A-240-15(3)
Sandoz GmbH
Austria
Biochemiestrasse 10, A-62...
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Seongui Bio Co., Ltd.
2012-06-08
20120608-30-A-260-18
Zhuhai United Laboratorie...
China
No.2428, Anji Road, Sanza...
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Penmix Co., Ltd.
2013-06-04
20120608-30-A-260-18(5)
Zhuhai United Laboratorie...
China
No.2428, Anji Road, Sanza...
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Daewoong Pharmaceutical Co., Ltd.
2013-05-22
20120608-30-A-260-18(4)
Zhuhai United Laboratorie...
China
No.2428, Anji Road, Sanza...
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Chong Kun Dang Co., Ltd.
2013-05-22
20120608-30-A-260-18(3)
Zhuhai United Laboratorie...
China
No.2428, Anji Road, Sanza...
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Samjin Pharmaceutical Co., Ltd.
2013-01-17
20120608-30-A-260-18(2)
Zhuhai United Laboratorie...
China
No.2428, Anji Road, Sanza...
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Sungwoo Chemical Co., Ltd.
2017-06-28
20120608-30-A-260-18(6)
Zhuhai United Laboratorie...
China
No.2428, Anji Road, Sanza...
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Looking for 34642-77-8 / Amoxicillin Sodium API manufacturers, exporters & distributors?

Amoxicillin Sodium manufacturers, exporters & distributors 1

68

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

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

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

API | Excipient name

Amoxicillin Sodium

Synonyms

34642-77-8, Acuotricina, Ibiamox, Sodium amoxicillin, Amoxicillin natrium, Amoxicillin (sodium)

Cas Number

34642-77-8

Unique Ingredient Identifier (UNII)

544Y3D6MYH

About Amoxicillin Sodium

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

Amoxicillin Sodium Manufacturers

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

Amoxicillin Sodium Suppliers

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

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

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

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

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

Amoxicillin Sodium Manufacturers | Traders | Suppliers

Amoxicillin Sodium Manufacturers, Traders, Suppliers 1
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We have 3 companies offering Amoxicillin Sodium

Get in contact with the supplier of your choice:

  1. GSK
  2. Sandoz B2B
  3. Zhuhai United Laboratories Co ., Ltd.
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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