Company profile for High Tech Pharm Co., Ltd

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About

Hi-Tech Farm's status, which has entered over 40 countries worldwide, will be upgraded by the operation of the Chungju plant. The Chungju plant was completed in accordance with the US FDA and European EDQM standards from the design stage to enter regulated markets with high entry barriers such as the US, Europe, and Japan. And if the regulatory market is approved, we will further solidify our position as a global pharmaceut...
Hi-Tech Farm's status, which has entered over 40 countries worldwide, will be upgraded by the operation of the Chungju plant. The Chungju plant was completed in accordance with the US FDA and European EDQM standards from the design stage to enter regulated markets with high entry barriers such as the US, Europe, and Japan. And if the regulatory market is approved, we will further solidify our position as a global pharmaceutical company specializing in carbapenem antibiotics with the world's best and largest production facilities for carbapenem antibiotics.

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CONTACT DETAILS

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Country
Country
South Korea
Address
Address
27466 12, Cheomdansaneop 6-ro, Daesowon-myeon, Chungju-si, Chungcheongbuk-do
Telephone
Telephone
+82.(0).43.880.0011-3
Linkedin
Linkedin
youtube
YouTube
Twitter
Twitter

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Events

Webinars & Exhibitions

PEGS Boston Summit

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envelop Contact Supplier

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Meeting

01

Imipenem

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Imipenem

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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USDMF CEP/COS JDMF arrow-down EU-WC NDC KDMF VMF Others AUDIT
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JDMF

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High Tech Pharm Co., Ltd

Registration Number : 304MF10138

Registrant's Address : 12, Cheomdansaneop 6-ro, Daesowon-myeon, Chungju-si, Chungcheongbuk-do, 27466, Korea

Initial Date of Registration : 2022-10-05

Latest Date of Registration : 2022-10-05

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Inspections and registrations

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FDA

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FDA Audited

USA
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FDA Audited

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High Tech Pharm Co., Ltd

City : Eumseong

State :

Country/Area : South Korea

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2023-10-13

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FDA Audited

USA
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FDA Audited

USA
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High Tech Pharm Co., Ltd

City : Chungju

State :

Country/Area : South Korea

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2022-11-11

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FDA Audited

USA
PEGS Boston Summit
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FDA Audited

USA
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High Tech Pharm Co., Ltd

City : Eumseong

State :

Country/Area : South Korea

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-09-28

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FDA Audited

USA
PEGS Boston Summit
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FDA Audited

USA
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High Tech Pharm Co., Ltd

City : Eumseong

State :

Country/Area : South Korea

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2015-03-27

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FDA Audited

USA
PEGS Boston Summit
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FDA Audited

USA
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High Tech Pharm Co., Ltd

City : Eumseong

State :

Country/Area : South Korea

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2011-09-21

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GDUFA

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GDUFA fees paid

USA
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GDUFA fees paid

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API Manufacturer : API MANUFACTURE

FDF Manufacturer :

Facility Name : HIGH TECH PHARM Co. Ltd.

Business Address : 280, SINNAE-RO Daeso-Myeon, ...

FEI Number : 3003663236

Country : South Korea

Paid in : 2019

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ABOUT THIS PAGE

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High Tech Pharm Co., Ltd is a supplier offers 1 products (APIs, Excipients or Intermediates).

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