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

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01 Chong Kun Dang Bio Co., Ltd._x000D_ (4)

02 Fermic S.A. de CV (2)

03 Fermic SA DE CV (5)

04 Fermic SA DE. CV (2)

05 Fermic SA DE.CV (1)

06 Fermic SA de. CV (1)

07 Fermic, SA DE CV (1)

08 Fermic, SA de. CV (2)

09 Lek Pharmaceuticals d.d. (9)

10 Lek farmacevtska družba dd, Poslovna enota Proizvodnja Lendava (2)

11 SHANDONG NEW TIME PHARMACEUTICAL CO.,LTD (3)

12 Shandong New Time Pharmaceutical Co., Ltd. (3)

13 Shandong New Time Pharmaceutical Co.,Ltd. (6)

14 Sinopharm Weiqida Pharmaceutical Co., Ltd. (2)

15 SmithKline Beecham PLC (2)

16 SmithKline Beecham Pharmaceuticals (3)

17 Zhuai United Laboratories Co., Ltd. (2)

18 Zhuhai United Laboratories Co., Ltd. (8)

19 lek pharmaceuticals dd (1)

20 lek pharmaceuticals dd, (2)

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01 Boryeong Co., Ltd. (8)

02 Chong Kun Dang Bio Co., Ltd. (4)

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

04 Daewoong Pharmaceutical Co., Ltd. (1)

05 GlaxoSmithKline Co., Ltd. (3)

06 Hwail Pharmaceutical Co., Ltd. (5)

07 Ilsung Pharmaceutical Co., Ltd. (2)

08 Inist Farm Co., Ltd. (2)

09 Inist ST Co., Ltd. (1)

10 Korea United Pharmaceutical Co., Ltd. (4)

11 Leesung International Co., Ltd. (5)

12 Masung LS Co., Ltd. (2)

13 Penmix Co., Ltd. (11)

14 Samjin Pharmaceutical Co., Ltd. (2)

15 Seongui Bio Co., Ltd. (2)

16 Seongyi Pharmaceutical Co., Ltd. (1)

17 Shinpoong Pharmaceutical Co., Ltd. (1)

18 Sungjin Exim Co., Ltd. (3)

19 Sungwoo Chemical Co., Ltd. (1)

20 Yuhan Corporation (1)

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01 Potassium clavulanate (61)

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01 China (24)

02 Mexico (14)

03 Slovenia (14)

04 South Korea (4)

05 United Kingdom (5)

URL Supplier Web Content
Inist ST Co., Ltd.
2018-01-25
20090617-113-F-45-14(5)
Fermic, SA de. CV
Mexico
Reforma No. 873 Col. San ...
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GSK

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  • FDA
  • EDQM
  • WHO-GMP
URL Supplier Web Content
GlaxoSmithKline Co., Ltd.
2020-03-10
20200310-113-F-91-24
SmithKline Beecham Pharma...
United Kingdom
Shewalton Road, Irvine, K...
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URL Supplier Web Content
Leesung International Co., Ltd.
2022-04-25
20220425-113-F-96-26
Lek farmacevtska družba ...
Slovenian
Trimlini 2D, Lendava, 922...
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URL Supplier Web Content
Leesung International Co., Ltd.
2022-04-25
20220425-113-F-95-25
Lek farmacevtska družba ...
Slovenian
Trimlini 2D, Lendava, 922...
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Yuhan Corporation
2018-02-08
20081031-113-F-10-03(4)
lek pharmaceuticals dd
Slovenian
Perzonali 47, SI-2391 Pre...
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Hwail Pharmaceutical Co., Ltd.
2017-10-25
20120615-113-F-68-17(4)
Shandong New Time Pharmac...
China
No.1, North Outer Ring Ro...
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URL Supplier Web Content
Boryeong Co., Ltd.
2017-07-27
20120615-113-F-68-17(3)
Shandong New Time Pharmac...
China
No.1, North Outer Ring Ro...
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Hwail Pharmaceutical Co., Ltd.
2018-01-16
20120615-113-F-69-16(1)
Shandong New Time Pharmac...
China
No.1, North Outer Ring Ro...
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Hwail Pharmaceutical Co., Ltd.
2017-10-25
20120615-113-F-67-18(4)
Shandong New Time Pharmac...
China
No.1, North Outer Ring Ro...
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Sungwoo Chemical Co., Ltd.
2017-06-28
20101130-113-F-56-15(7)
Zhuhai United Laboratorie...
China
No.2428, Anji Road, Sanza...
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Looking for 61177-45-5 / Clavulanic Acid API manufacturers, exporters & distributors?

Clavulanic Acid manufacturers, exporters & distributors 1

24

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

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

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

API | Excipient name

Clavulanic Acid

Synonyms

Potassium clavulanate, 61177-45-5, Clavulanic acid potassium salt, Brl 14151k, Clavulanate (potassium), Q42omw3at8

Cas Number

61177-45-5

Unique Ingredient Identifier (UNII)

Q42OMW3AT8

About Clavulanic Acid

A beta-lactam antibiotic produced by the actinobacterium Streptomyces clavuligerus. It is a suicide inhibitor of bacterial beta-lactamase enzymes. Administered alone, it has only weak antibacterial activity against most organisms, but given in combination with other beta-lactam antibiotics it prevents antibiotic inactivation by microbial lactamase.

Clavulanic Acid Manufacturers

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

Clavulanic Acid Suppliers

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

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

Clavulanic Acid KDMF

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

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

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

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

Clavulanic Acid Manufacturers | Traders | Suppliers

Clavulanic Acid 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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