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List of Korea Drug Master Files (KDMF) for PREVPAC-1 Active Pharmaceutical Ingredient submitted to the Review Authority in Korea and listed on PharmaCompass.com

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Kyungdong Pharmaceutical Co., Ltd.
2011-06-30
20050831-62-A-163-05(2)
Alembic Pharmaceuticals L...
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Vill Panelav, PO Tajpura,...
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Korea Pharmaceutical Co., Ltd.
2012-03-30
20050831-62-A-163-05(6)
Alembic Pharmaceuticals L...
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2011-06-15
20050831-62-A-163-05(1)
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IMCD Korea Co., Ltd.
2011-08-19
20050831-62-A-163-05(4)
Alembic Pharmaceuticals L...
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Vill Panelav, PO Tajpura,...
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Aging Life Science Co., Ltd.
2018-10-24
20130221-62-A-273-20(1)
HEC Pharm Co., Ltd
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Aging Life Science Co., Ltd.
2013-02-21
20130221-62-A-273-20
HEC Pharm Co., Ltd
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Masung LS Co., Ltd.
2020-05-04
20130221-62-A-273-20(2)
HEC Pharm Co., Ltd
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Samchundang Pharmaceutical Co., Ltd.
2011-04-14
20050915-62-A-169-09(3)
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2015-09-15
20050915-62-A-169-09(11)
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2017-04-17
20050831-62-A-119-02(9)
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20050831-62-A-119-02(7)
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2020-03-11
20050831-62-A-119-02(11)
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2013-03-12
20050831-62-A-119-02(6)
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2019-09-04
20050831-62-A-119-02(10)
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2020-08-28
20050831-62-A-119-02(12)
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Myungmoon Pharmaceutical Co., Ltd.
2014-08-28
20050831-62-A-119-02(8)
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2012-08-31
20050915-62-A-169-09(9)
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Daewon Pharmaceutical Co., Ltd.
2014-06-19
20050915-62-A-169-09(10)
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Sama Pharmaceutical Co., Ltd.
2011-04-14
20050915-62-A-169-09(5)
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Shinpoong Pharmaceutical Co., Ltd.
2011-07-29
20050831-62-A-119-02(3)
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Sama Pharmaceutical Co., Ltd.
2011-04-29
20050831-62-A-119-02(2)
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HLB Pharmaceutical Co., Ltd.
2021-04-28
20050831-62-A-119-02(13)
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Unimed Pharmaceutical Co., Ltd.
2015-01-20
20110630-62-A-247-18(8)
Zhejiang Better Pharmaceu...
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Sanjiang Road, Paojiang I...
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Farm East Co., Ltd.
2020-03-18
20110630-62-A-247-18(13)
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Sanjiang Road, Paojiang I...
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Korea United Pharmaceutical Co., Ltd.
2012-05-25
20110630-62-A-247-18(3)
Zhejiang Better Pharmaceu...
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Sanjiang Road, Paojiang I...
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Ecell Bio Co., Ltd.
2014-02-27
20110630-62-A-247-18(5)
Zhejiang Better Pharmaceu...
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Sanjiang Road, Paojiang I...
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Donggu Bio Pharmaceutical Co., Ltd.
2012-04-20
20110630-62-A-247-18(2)
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Sanjiang Road, Paojiang I...
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Core Farm Bio Co., Ltd.
2011-06-30
20110630-62-A-247-18
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Sanjiang Road, Paojiang I...
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Toru Co., Ltd.
2020-06-22
20110630-62-A-247-18(14)
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Sanjiang Road, Paojiang I...
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Dasan Pharmaceutical Co., Ltd.
2011-09-16
20110630-62-A-247-18(1)
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Sanjiang Road, Paojiang I...
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Daewon Pharmaceutical Co., Ltd.
2014-08-08
20110630-62-A-247-18(7)
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Sanjiang Road, Paojiang I...
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Leaders Bio Co., Ltd.
2014-07-25
20110630-62-A-247-18(6)
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Sanjiang Road, Paojiang I...
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JW Shinyak Co., Ltd.
2013-05-21
20110630-62-A-247-18(4)
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Sanjiang Road, Paojiang I...
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Theragen Etex Co., Ltd.
2019-07-16
20110630-62-A-247-18(12)
Zhejiang Better Pharmaceu...
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Sanjiang Road, Paojiang I...
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Huons Co., Ltd.
2015-10-16
20110630-62-A-247-18(11)
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Sanjiang Road, Paojiang I...
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Boryeong Co., Ltd.
2015-01-20
20110630-62-A-247-18(9)
Zhejiang Better Pharmaceu...
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Sanjiang Road, Paojiang I...
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Korea United Pharmaceutical Co., Ltd.
2013-04-05
20130123-62-A-268-19(2)
Zhejiang Guobang Pharmace...
China
No. 6, Weiwu Road, Hangzh...
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Boryeong Co., Ltd.
2014-11-20
20130123-62-A-268-19(6)
Zhejiang Guobang Pharmace...
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No. 6, Weiwu Road, Hangzh...
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Bahnsen Co., Ltd.
2018-05-08
20130123-62-A-268-19(A)
Zhejiang Guobang Pharmace...
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No. 6, Weiwu Road, Hangzh...
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Leaders Bio Co., Ltd.
2017-02-14
20130123-62-A-268-19(11)
Zhejiang Guobang Pharmace...
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No. 6, Weiwu Road, Hangzh...
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Hanyoung Farm Co., Ltd.
2021-04-26
20130123-62-A-268-19(15)
Zhejiang Guobang Pharmace...
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No. 6, Weiwu Road, Hangzh...
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Leeyeon Pharmaceutical Co., Ltd.
2014-08-22
20130123-62-A-268-19(5)
Zhejiang Guobang Pharmace...
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No. 6, Weiwu Road, Hangzh...
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Hiple Co., Ltd.
2016-09-09
20130123-62-A-268-19(9)
Zhejiang Guobang Pharmace...
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Daesin Pharmaceutical Co., Ltd.
2013-11-08
20130123-62-A-268-19(4)
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Sangjin Trading Co., Ltd.
2013-01-23
20130123-62-A-268-19
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Saintec Pharma Co., Ltd.
2016-08-10
20130123-62-A-268-19(8)
Zhejiang Guobang Pharmace...
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Unimed Pharmaceutical Co., Ltd.
2019-06-12
20130123-62-A-268-19(14)
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Pharmapia Co., Ltd.
2016-07-06
20130123-62-A-268-19(7)
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Guju Pharmaceutical Co., Ltd.
2017-05-04
20130123-62-A-268-19(12)
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Saintec Pharma Co., Ltd.
2019-01-10
20190110-62-A-358-21
Zhejiang Zhongtong Pharma...
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No.60, Xingmei Avenue, Pr...
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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**
  • FOR SUSPENSION;ORAL - 125MG/5ML
  • FOR SUSPENSION;ORAL - 250MG/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**
  • TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • 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 81103-11-9 / Clarithromycin API manufacturers, exporters & distributors?

Clarithromycin manufacturers, exporters & distributors 1

48

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

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

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

API | Excipient name

Clarithromycin

Synonyms

81103-11-9, Biaxin, 6-o-methylerythromycin, Klaricid, 6-o-methylerythromycin a, Abbott-56268

Cas Number

81103-11-9

Unique Ingredient Identifier (UNII)

H1250JIK0A

About Clarithromycin

A semisynthetic macrolide antibiotic derived from ERYTHROMYCIN that is active against a variety of microorganisms. It can inhibit protein synthesis in bacteria by reversibly binding to the 50S ribosomal subunits. This inhibits the translocation of aminoacyl transfer-RNA and prevents peptide chain elongation.

PREVPAC-1 Manufacturers

A PREVPAC-1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of PREVPAC-1, including repackagers and relabelers. The FDA regulates PREVPAC-1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. PREVPAC-1 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 PREVPAC-1 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

PREVPAC-1 Suppliers

A PREVPAC-1 supplier is an individual or a company that provides PREVPAC-1 active pharmaceutical ingredient (API) or PREVPAC-1 finished formulations upon request. The PREVPAC-1 suppliers may include PREVPAC-1 API manufacturers, exporters, distributors and traders.

click here to find a list of PREVPAC-1 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

PREVPAC-1 KDMF

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

Pharmaceutical companies submit a PREVPAC-1 Drug Master File in Korea (PREVPAC-1 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of PREVPAC-1. The MFDS reviews the PREVPAC-1 KDMF as part of the drug registration process and uses the information provided in the PREVPAC-1 KDMF to evaluate the safety and efficacy of the drug.

After submitting a PREVPAC-1 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 PREVPAC-1 API can apply through the Korea Drug Master File (KDMF).

click here to find a list of PREVPAC-1 suppliers with KDMF on PharmaCompass.

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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