Company profile for Hemofarm A.D.

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About

Hemofarm’s core activity is production of high-quality, safe, effective and available generic pharmaceutical products by applying high-end technologies. Hemofarm manufactures medicinal products of all pharmaco-therapeutic groups and forms, from simplest to most complex ones: it sells products of 12 (out of 14) pharmaco-therapeutic groups according to the ATC classification, portfolio contains 192 products by INN, with 38...
Hemofarm’s core activity is production of high-quality, safe, effective and available generic pharmaceutical products by applying high-end technologies. Hemofarm manufactures medicinal products of all pharmaco-therapeutic groups and forms, from simplest to most complex ones: it sells products of 12 (out of 14) pharmaco-therapeutic groups according to the ATC classification, portfolio contains 192 products by INN, with 388 forms and dosages, portfolio is focused on most important pharmaco-therapeutic groups, such as products for cardiovascular diseases, antibiotics and neuropsychiatric products, over-the-counter (OTC) products have a leading position in the Serbian pharmaceutical market, with a share exceeding 13%, constant improvement of portfolio with new generations of medicines, development of new segments, primarily oncology. Hemofarm is a leader in the local market of pharmaceuticals, competing against 300 manufacturers and distributors1, with a share of 34% in goods, i.e. 17.5% in value. Business operations within STADA Group open additional possibilities for sales of products to very demanding EU markets. The new strategic portfolio approach has been ‘tailor-made’ to suit the requirements of each region.it sells products of 12 (out of 14) pharmaco-therapeutic groups according to the ATC classification, portfolio contains 192 products by INN, with 388 forms and dosages, portfolio is focused on most important pharmaco-therapeutic groups, such as products for cardiovascular diseases, antibiotics and neuropsychiatric products, over-the-counter (OTC) products have a leading position in the Serbian pharmaceutical market, with a share exceeding 13%, constant improvement of portfolio with new generations of medicines, development of new segments, primarily oncology. Hemofarm is a leader in the local market of pharmaceuticals, competing against 300 manufacturers and distributors1, with a share of 34% in goods, i.e. 17.5% in value. Business operations within STADA Group open additional possibilities for sales of products to very demanding EU markets. The new strategic portfolio approach has been ‘tailor-made’ to suit the requirements of each region.

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CONTACT DETAILS

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Country
Country
Serbia
Address
Address
Belgrade put bb , 26300 Vrsac
Telephone
Telephone
+38113803100, +38113804100
Linkedin
Linkedin
youtube
YouTube
Twitter
Twitter

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NEWS #PharmaBuzz

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http://www.prnewswire.com/news-releases/the-top-100-manufacturers-of-generic-pharmaceuticals-worldwide-300380245.html

PR NEWSWIRE
16 Dec 2016

FDF Dossiers

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Brand Name : Amoxicillin

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Brand Name : Amoxicillin

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Hemofarm A.D.

Dosage Form : Granule For Oral Suspens...

Brand Name : Amoxicillin

Dosage Strength : 250mg/5ml

Packaging :

Approval Date : 31-07-2024

Application Number :

Regulatory Info :

Registration Country : Moldova

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Brand Name : Hemomycin

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Brand Name : Hemomycin

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Hemofarm A.D.

Dosage Form : Powder For Oral Suspensi...

Brand Name : Hemomycin

Dosage Strength : 200mg/5ml

Packaging :

Approval Date : 19-07-2023

Application Number :

Regulatory Info :

Registration Country : Moldova

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Brand Name : Hemomycin

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Brand Name : Hemomycin

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Hemofarm A.D.

Dosage Form : Film Coated Tablet

Brand Name : Hemomycin

Dosage Strength : 500mg

Packaging :

Approval Date : 27-05-2022

Application Number :

Regulatory Info :

Registration Country : Moldova

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Brand Name : Hemomycin

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Hemofarm A.D.

Dosage Form : Capsule

Brand Name : Hemomycin

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Approval Date : 27-02-2023

Application Number :

Regulatory Info :

Registration Country : Moldova

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Brand Name : Omnitus

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Brand Name : Omnitus

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Hemofarm A.D.

Dosage Form : Syrup

Brand Name : Omnitus

Dosage Strength : 0.8mg/ml

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Approval Date : 29-11-2021

Application Number :

Regulatory Info :

Registration Country : Moldova

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Brand Name : Omnitus

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Hemofarm A.D.

Dosage Form : Modified Release Tablet

Brand Name : Omnitus

Dosage Strength : 50mg

Packaging :

Approval Date : 01-11-2022

Application Number :

Regulatory Info :

Registration Country : Moldova

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Brand Name : Diclofenac

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Brand Name : Diclofenac

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Hemofarm A.D.

Dosage Form : Gel

Brand Name : Diclofenac

Dosage Strength : 10mg/g

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Approval Date : 24-06-2023

Application Number :

Regulatory Info :

Registration Country : Moldova

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Brand Name : Diclofenac

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Hemofarm A.D.

Dosage Form : Injectable Solution

Brand Name : Diclofenac

Dosage Strength : 25mg/ml

Packaging :

Approval Date : 31-07-2024

Application Number :

Regulatory Info :

Registration Country : Moldova

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Brand Name : Diclofenac

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Hemofarm A.D.

Dosage Form : Gastro-Resistant Tablet

Brand Name : Diclofenac

Dosage Strength : 50mg

Packaging :

Approval Date : 25-01-2024

Application Number :

Regulatory Info :

Registration Country : Moldova

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Brand Name : Diclofenac

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Hemofarm A.D.

Dosage Form : Extended Release Tablet

Brand Name : Diclofenac

Dosage Strength :

Packaging :

Approval Date : 31-01-2023

Application Number :

Regulatory Info :

Registration Country : Moldova

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Europe

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01

Brand Name : Amoxicillin

IPhEB Russia
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Brand Name : Amoxicillin

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IPhEB Russia
Not Confirmed

Hemofarm A.D.

Dosage Form : Granule For Oral Suspension

Dosage Strength : 250mg/5ml

Packaging :

Brand Name : Amoxicillin

Approval Date : 31-07-2024

Application Number :

Regulatory Info :

Registration Country : Moldova

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02

Brand Name : Hemomycin

IPhEB Russia
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Brand Name : Hemomycin

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IPhEB Russia
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Hemofarm A.D.

Dosage Form : Powder For Oral Suspension

Dosage Strength : 200mg/5ml

Packaging :

Brand Name : Hemomycin

Approval Date : 19-07-2023

Application Number :

Regulatory Info :

Registration Country : Moldova

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03

Brand Name : Hemomycin

IPhEB Russia
Not Confirmed
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Brand Name : Hemomycin

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IPhEB Russia
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Hemofarm A.D.

Dosage Form : Film Coated Tablet

Dosage Strength : 500mg

Packaging :

Brand Name : Hemomycin

Approval Date : 27-05-2022

Application Number :

Regulatory Info :

Registration Country : Moldova

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Brand Name : Hemomycin

IPhEB Russia
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Brand Name : Hemomycin

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IPhEB Russia
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Hemofarm A.D.

Dosage Form : Capsule

Dosage Strength :

Packaging :

Brand Name : Hemomycin

Approval Date : 27-02-2023

Application Number :

Regulatory Info :

Registration Country : Moldova

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05

Brand Name : Omnitus

IPhEB Russia
Not Confirmed
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Brand Name : Omnitus

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IPhEB Russia
Not Confirmed

Hemofarm A.D.

Dosage Form : Syrup

Dosage Strength : 0.8mg/ml

Packaging :

Brand Name : Omnitus

Approval Date : 29-11-2021

Application Number :

Regulatory Info :

Registration Country : Moldova

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Brand Name : Omnitus

IPhEB Russia
Not Confirmed
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Brand Name : Omnitus

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IPhEB Russia
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Hemofarm A.D.

Dosage Form : Modified Release Tablet

Dosage Strength : 50mg

Packaging :

Brand Name : Omnitus

Approval Date : 01-11-2022

Application Number :

Regulatory Info :

Registration Country : Moldova

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Brand Name : Diclofenac

IPhEB Russia
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Brand Name : Diclofenac

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IPhEB Russia
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Hemofarm A.D.

Dosage Form : Gel

Dosage Strength : 10mg/g

Packaging :

Brand Name : Diclofenac

Approval Date : 24-06-2023

Application Number :

Regulatory Info :

Registration Country : Moldova

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Brand Name : Diclofenac

IPhEB Russia
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Brand Name : Diclofenac

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IPhEB Russia
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Hemofarm A.D.

Dosage Form : Injectable Solution

Dosage Strength : 25mg/ml

Packaging :

Brand Name : Diclofenac

Approval Date : 31-07-2024

Application Number :

Regulatory Info :

Registration Country : Moldova

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Brand Name : Diclofenac

IPhEB Russia
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Brand Name : Diclofenac

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IPhEB Russia
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Hemofarm A.D.

Dosage Form : Gastro-Resistant Tablet

Dosage Strength : 50mg

Packaging :

Brand Name : Diclofenac

Approval Date : 25-01-2024

Application Number :

Regulatory Info :

Registration Country : Moldova

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Brand Name : Diclofenac

IPhEB Russia
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Brand Name : Diclofenac

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IPhEB Russia
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Hemofarm A.D.

Dosage Form : Extended Release Tablet

Dosage Strength :

Packaging :

Brand Name : Diclofenac

Approval Date : 31-01-2023

Application Number :

Regulatory Info :

Registration Country : Moldova

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Inspections and registrations

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FDA

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FDA Audited

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FDA Audited

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Hemofarm A.D.

City : Vrsac

State :

Country/Area : Serbia

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2015-05-08

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FDA Audited

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Hemofarm A.D.

City : Vrsac

State :

Country/Area : Serbia

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Official Action Indicated

Inspection End Date : 2011-11-22

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EDQM

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GMP Certified

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Hemofarm A.D.

Type : GMP Certificates

Number : DE_HE_01_GM...

EudraGMDP Key : 16597

Country : Serbia

Issue Date : 2013-05-29

Post Code : 26300

NCA Ref : 18367

City : Vrsac

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GMP Certified

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IPhEB Russia
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GMP Certified

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Hemofarm A.D.

Type : GMP Certificates

Number : DE_HE_01_GM...

EudraGMDP Key : 16597

Country : Serbia

Issue Date : 2013-05-29

Post Code : 26300

NCA Ref : 18367

City : Vrsac

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GMP Certified

EU
IPhEB Russia
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GMP Certified

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Hemofarm A.D.

Type : GMP Certificates

Number : DE_HE_01_GM...

EudraGMDP Key : 16597

Country : Serbia

Issue Date :

Post Code : 26300

NCA Ref : 18367

City : Vrsac

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GMP Certified

EU
IPhEB Russia
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GMP Certified

EU
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IPhEB Russia
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Hemofarm A.D.

Type : GMP Certificates

Number : DE_HE_01_GM...

EudraGMDP Key : 26753

Country : Serbia

Issue Date :

Post Code : 26300

NCA Ref : 20731

City : Vrsac

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GMP Certified

EU
IPhEB Russia
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GMP Certified

EU
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IPhEB Russia
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Hemofarm A.D.

Type : GMP Certificates

Number : DE_ST_01_GM...

EudraGMDP Key : 16097

Country : Serbia

Issue Date :

Post Code : 26300

NCA Ref : 14077

City : Vrsac

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GMP Certified

EU
IPhEB Russia
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GMP Certified

EU
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IPhEB Russia
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Hemofarm A.D.

Type : GMP Certificates

Number : DE_NI_02_GM...

EudraGMDP Key : 16097

Country : Serbia

Issue Date :

Post Code : 26300

NCA Ref : 14077

City : Vrsac

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GMP Certified

EU
IPhEB Russia
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GMP Certified

EU
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IPhEB Russia
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Hemofarm A.D.

Type : GMP Certificates

Number : DE_NI_02_GM...

EudraGMDP Key : 16097

Country : Serbia

Issue Date :

Post Code : 26300

NCA Ref : 14077

City : Vrsac

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GMP Certified

EU
IPhEB Russia
Not Confirmed
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GMP Certified

EU
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IPhEB Russia
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Hemofarm A.D.

Type : GMP Certificates

Number : DE_HE_01_GM...

EudraGMDP Key : 26732

Country : Serbia

Issue Date :

Post Code : 26300

NCA Ref : 20651

City : Vrsac

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GMP Certified

EU
IPhEB Russia
Not Confirmed
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GMP Certified

EU
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IPhEB Russia
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Hemofarm A.D.

Type : GMP Certificates

Number : 002/2011/RO

EudraGMDP Key : 8623

Country : Serbia

Issue Date :

Post Code : 26300

NCA Ref : 8.6231266911...

City : Vrsac

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GMP Certified

EU
IPhEB Russia
Not Confirmed
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GMP Certified

EU
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IPhEB Russia
Not Confirmed

Hemofarm A.D.

Type : GMP Certificates

Number : 002/2010/RO

EudraGMDP Key : 8623

Country : Serbia

Issue Date :

Post Code : 26300

NCA Ref : 8.6231266911...

City : Vrsac

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