14 Apr 2025
// GLOBENEWSWIRE
14 Apr 2025
// GLOBENEWSWIRE
14 Apr 2025
// INDPHARMAPOST
Latest Content by PharmaCompass
About
CPhI North America CPhI North America
Industry Trade Show
Not Confirmed
20-22 May, 2025
Industry Trade Show
Exhibiting
06-09 May, 2025
German Wound CongressGerman Wound Congress
Industry Trade Show
Not Confirmed
07 April-09 May, 2025
CONTACT DETAILS
Events
Webinars & Exhibitions
CPhI North America CPhI North America
Industry Trade Show
Not Confirmed
20-22 May, 2025
Industry Trade Show
Exhibiting
06-09 May, 2025
German Wound CongressGerman Wound Congress
Industry Trade Show
Not Confirmed
07 April-09 May, 2025
CORPORATE CONTENT #SupplierSpotlight
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10262
Submission : 1993-05-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5749
Submission : 1985-03-04
Status : Inactive
Type : II
NDC Package Code : 70366-001
Start Marketing Date : 2016-02-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kolon Pharmaceutical Co., Ltd.
Registration Date : 2013-06-10
Registration Number : 20130610-186-I-320-02
Manufacturer Name : Microchem SRL@Farmabios SpA (all processes except micronization process)
Manufacturer Address : Fiorenzuola D`Arda (PC) - Via Turati 2, Italy.@Gropello Cairoli (PV) - Via Pavia, 1, Italy.
NDC Package Code : 70366-002
Start Marketing Date : 2016-02-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 70366-003
Start Marketing Date : 2016-06-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 70366-004
Start Marketing Date : 2019-11-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10262
Submission : 1993-05-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5749
Submission : 1985-03-04
Status : Inactive
Type : II
Registrant Name : Kolon Pharmaceutical Co., Ltd.
Registration Date : 2013-06-10
Registration Number : 20130610-186-I-320-02
Manufacturer Name : Microchem SRL@Farmabios SpA (a...
Manufacturer Address : Fiorenzuola D`Arda (PC) - Via Turati 2, Italy.@Gropello Cairoli (PV) - Via Pavia, 1, ...
NDC Package Code : 70366-001
Start Marketing Date : 2016-02-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 70366-002
Start Marketing Date : 2016-02-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 70366-003
Start Marketing Date : 2016-06-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 70366-004
Start Marketing Date : 2019-11-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Services
API Manufacturing
Pharma Service : API Manufacturing
Category : Micronization
Sub Category : Overview
Pharma Service : API Manufacturing
Inspections and registrations
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-12-01
City : Balerna
State :
Country/Area : CH
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-12-01
District Decision : Voluntary Action Indicated
Inspection End Date : 2016-01-29
City : Balerna
State :
Country/Area : CH
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2016-01-29
District Decision : No Action Indicated
Inspection End Date : 2014-04-02
City : Fiorenzuola D'Arda
State :
Country/Area : IT
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2014-04-02
District Decision : No Action Indicated
Inspection End Date : 2013-05-08
City : Balerna
State :
Country/Area : CH
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2013-05-08
District Decision : Voluntary Action Indicated
Inspection End Date : 2011-07-13
City : Fiorenzuola D'Arda
State :
Country/Area : IT
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2011-07-13
District Decision : No Action Indicated
Inspection End Date : 2011-02-16
City : Balerna
State :
Country/Area : CH
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2011-02-16
API Manufacturer : API MANUFACTURE
FDF Manufacturer :
Facility Name : Jetpharma SA
Business Address : Via Sottobisio 42 Balerna 68...
FEI Number : 3002807359
Country : Switzerland
Paid in : 2019
API Manufacturer : API MANUFACTURE
FDF Manufacturer :
Facility Name : Microchem Srl
Business Address : Via Turati 2 Fiorenzuola d'A...
FEI Number : 3002807601
Country : Italy
Paid in : 2019
Inspection : OTHERS
About the Company : Instilled in the company is the DNA of complementary skills held by its founder engineer, Alberto Ma...
Country : Switzerland
Product
Web Link
Inspection : OTHERS
About the Company : Instilled in the company is the DNA of complementary skills held by its founder engineer, Alberto Ma...
Country : Switzerland
Product
Web Link
Inspection : OTHERS
About the Company : Microchem S.r.l. provides contract micronization of active and excipient ingredients for the pharmac...
Country : Italy
Product
Web Link
Inspection : OTHERS
About the Company : Microchem S.r.l. provides contract micronization of active and excipient ingredients for the pharmac...
Country : Italy
Product
Web Link
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