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Chemistry

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USDMF

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01

Chemport Inc

United Kingdom

USDMF

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Georgia Environmental
Not Confirmed

01

Chemport Inc

United Kingdom
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Georgia Environmental
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2014-12-18

Pay. Date : 2014-07-28

DMF Number : 28170

Submission : 2014-03-28

Status : Active

Type : II

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02

Ci Naturmega Sa

U.S.A

USDMF

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Georgia Environmental
Not Confirmed

02

Georgia Environmental
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 26880

Submission : 2013-03-21

Status : Inactive

Type : II

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03

Kd Pharma Bexbach Gmbh

Germany

USDMF

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Georgia Environmental
Not Confirmed

03

Georgia Environmental
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2014-01-03

Pay. Date : 2013-12-19

DMF Number : 22100

Submission : 2008-11-07

Status : Active

Type : II

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04

Georgia Environmental
Not Confirmed

04

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CEP/COS

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01

Georgia Environmental
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Georgia Environmental
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Certificate Number : CEP 2007-366 - Rev 03

Status : Valid

Issue Date : 2023-10-06

Type : Chemical

Substance Number : 1352

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Georgia Environmental
Not Confirmed
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Certificate Number : R1-CEP 2016-130 - Rev 00

Status : Valid

Issue Date : 2021-08-06

Type : Chemical

Substance Number : 1250

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JDMF

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01

Georgia Environmental
Not Confirmed
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Omega-3 fatty acid ethyl

Registration Number : 303MF10027

Registrant's Address : Industrial Park, Xiaohan Town, Deyang, Sichuan, P. R. China

Initial Date of Registration : 2021-02-10

Latest Date of Registration : 2021-02-10

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Georgia Environmental
Not Confirmed
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OMEGA-3-ACID ETHYL ESTERS 90

Registration Number : 303MF10016

Registrant's Address : No. 161, South Yinghuashan Road, Shifang, Deyang City, Sichuan, China

Initial Date of Registration : 2021-01-26

Latest Date of Registration : 2021-01-26

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KDMF

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01

AK BIOPHARM

South Korea
Georgia Environmental
Not Confirmed
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AK BIOPHARM

South Korea
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Georgia Environmental
Not Confirmed

Refined fish oil (high in omega-3 fatty acids)

Registrant Name : Aekyung Biopharm Co., Ltd.

Registration Date : 2020-12-04

Registration Number : 6148-2-ND

Manufacturer Name : Aekyung Biopharm Co., Ltd.

Manufacturer Address : 81 Sanggae-ro, Nam-gu, Ulsan Metropolitan City (80, 80A)

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02

Croda Europe Limited

United Kingdom
Georgia Environmental
Not Confirmed
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Croda Europe Limited

United Kingdom
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Georgia Environmental
Not Confirmed

Omega 3 triglyceride

Registrant Name : Bibraun Korea Co., Ltd.

Registration Date : 2009-08-21

Registration Number : Su511-1-ND

Manufacturer Name : Croda Europe LTD

Manufacturer Address : Barnfield Road, Leek Staffordshire ST13 5QJ, UK (Cowick Hall, Snaith, Goole, East Yor...

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API Reference Price

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[{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1740076200,"product":"OMEGA-3-ACID ETHYL ESTERS USP (KIN) (BATCH NO:240524-4638EE-01)","address":"206, DEVAVRATA,","city":"NAVI MUMBAI, MAHARASHTRA.","supplier":"STRIDES PHARMA SCIENCE LTD","supplierCountry":"INDIA","foreign_port":"XINGANG (CHINA)","customer":"KINOMEGA BIOPHARMA INC","customerCountry":"CHINA","quantity":"190.00","actualQuantity":"190","unit":"KGS","unitRateFc":"48.5","totalValueFC":"9118.1","currency":"USD","unitRateINR":4173.4250000000002,"date":"21-Feb-2025","totalValueINR":"792950.75","totalValueInUsd":"9118.1","indian_port":"Bangalore ICD","hs_no":"29349990","bill_no":"8388396","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bangalore ICD","supplierAddress":"206, DEVAVRATA,, NAVI MUMBAI, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1740162600,"product":"OMEGA-3-ACID ETHYL ESTERS USP (KIN) (BATCH NO:240524-4638EE-01)","address":"206, DEVAVRATA,","city":"NAVI MUMBAI, MAHARASHTRA.","supplier":"STRIDES PHARMA SCIENCE LTD","supplierCountry":"INDIA","foreign_port":"XINGANG (CHINA)","customer":"KINOMEGA BIOPHARMA INC","customerCountry":"CHINA","quantity":"190.00","actualQuantity":"190","unit":"KGS","unitRateFc":"48.5","totalValueFC":"9118.1","currency":"USD","unitRateINR":4173.4250000000002,"date":"22-Feb-2025","totalValueINR":"792950.75","totalValueInUsd":"9118.1","indian_port":"Bangalore ICD","hs_no":"29349990","bill_no":"8399067","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bangalore ICD","supplierAddress":"206, DEVAVRATA,, NAVI MUMBAI, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1673548200,"product":"OMEGA-3 ACID ETHYL ESTERS - (FOR PHARMACEUTICAL USE)","address":"11TH FLR.GRANDEUR,OPP.GUNDECHA,SYM PHONY, VEERA DESAI RD.EXTENSION","city":"MUMBAI SUBURBAN,MAHARASHTRA","supplier":"KINOMEGA BIOPHARM INC","supplierCountry":"CHINA","foreign_port":"NA","customer":"MARKSANS PHARMA LTD","customerCountry":"INDIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"120","totalValueFC":"614.2","currency":"USD","unitRateINR":"10044","date":"13-Jan-2023","totalValueINR":"50220","totalValueInUsd":"614.2","indian_port":"BOMBAY AIR","hs_no":"29157090","bill_no":"4171182","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"11TH FLR.GRANDEUR,OPP.GUNDECHA,SYM PHONY, VEERA DESAI RD.EXTENSION"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1691605800,"product":"OMEGA-3 FATTY ACID SAMPLES FREE SAMPLE FOR LAB USE, NO COMMERCIAL VALUE","address":"NA","city":"NA","supplier":"KINOMEGA BIOPHARM INC","supplierCountry":"CHINA","foreign_port":"NA","customer":"H H HEALTH CARE COSMETICS PRIVATE LTD","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"110","totalValueFC":"1342","currency":"USD","unitRateINR":"11005.3","date":"10-Aug-2023","totalValueINR":"111164.592","totalValueInUsd":"1342","indian_port":"SAHAR AIR","hs_no":"29054900","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"NA"}]
13-Jan-2023
22-Feb-2025
KGS
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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

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API Imports and Exports

Importing Country Total Quantity
(KGS)
Average Price
(USD/KGS)
Number of Transactions

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Drugs in Development

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Details:

Under the terms of the agreement Nuvothera has acquired an option to exclusively licence rights to develop and commercialise EPADILIN® in the United States.


Lead Product(s): Omega-3,Omega 6

Therapeutic Area: Dermatology Brand Name: Epadilin

Study Phase: Approved FDFProduct Type: Vitamins/Minerals/Inorganic Salts

Sponsor: Nuvothera

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement March 18, 2021

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01

DS Biopharma

Ireland
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Georgia Environmental
Not Confirmed

DS Biopharma

Ireland
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Georgia Environmental
Not Confirmed

Details : Under the terms of the agreement Nuvothera has acquired an option to exclusively licence rights to develop and commercialise EPADILIN® in the United States.

Product Name : Epadilin

Product Type : Vitamins/Minerals/Inorganic Salts

Upfront Cash : Undisclosed

March 18, 2021

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  • Development Update

Details:

Acasti Pharma plans to seek FDA guidance prior to unblinding TRILOGY 2 data, which is expected to delay reporting of TRILOGY 2 topline results until calendar Q3, 2020.


Lead Product(s): Omega-3

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Vitamins/Minerals/Inorganic Salts

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 02, 2020

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02

Acasti Pharma

Country
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Georgia Environmental
Not Confirmed

Acasti Pharma

Country
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Georgia Environmental
Not Confirmed

Details : Acasti Pharma plans to seek FDA guidance prior to unblinding TRILOGY 2 data, which is expected to delay reporting of TRILOGY 2 topline results until calendar Q3, 2020.

Product Name : Undisclosed

Product Type : Vitamins/Minerals/Inorganic Salts

Upfront Cash : Inapplicable

October 02, 2020

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FDF Dossiers

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01

Georgia Environmental
Not Confirmed
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Omega-3 fatty acids

Brand Name : Nutriflex Omega Plus

Dosage Form : INF

Dosage Strength : 4g/1000ml

Packaging : 1250X1g/1000ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Georgia Environmental
Not Confirmed
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Georgia Environmental
Not Confirmed

Omega-3 fatty acids

Brand Name : Nutriflex Omega Specialized

Dosage Form : INF

Dosage Strength : 4g/1000ml

Packaging : 1250X1g/1000ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Farmak JSC

Ukraine
Georgia Environmental
Not Confirmed
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Farmak JSC

Ukraine
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Georgia Environmental
Not Confirmed

Omega-3; Ascorbic Acid; Vitamin E; Lutein; Zinc Oxide; zeaxanthin; Copper Sulfate

Brand Name : VisiloTON complex

Dosage Form : Capsule

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Ukraine

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Kyiv Vitamin

Ukraine
Georgia Environmental
Not Confirmed
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Kyiv Vitamin

Ukraine
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Georgia Environmental
Not Confirmed

Omega-3 fatty acids

Brand Name : Epadol Neo

Dosage Form : Soft Capsule

Dosage Strength : 1000MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Ukraine

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Georgia Environmental
Not Confirmed
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Georgia Environmental
Not Confirmed

Omega-3 acid ethyl esters 90

Brand Name : Omacor

Dosage Form : Kapsel, myk

Dosage Strength : 1000 mg

Packaging : Boks av plast 100item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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Country
Georgia Environmental
Not Confirmed
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Georgia Environmental
Not Confirmed

Omega-3

Brand Name : Omega 3 Aristo 1000Mg 100 Softgels (250Ml) Efg

Dosage Form : Softgels

Dosage Strength : 1000 Mg/Softgels

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Spain

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Country
Georgia Environmental
Not Confirmed
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Georgia Environmental
Not Confirmed

Omega-3

Brand Name : Omega 3 Kern Pharma 1,000Mg 100 Softgels Efg

Dosage Form : Softgels

Dosage Strength : 1000 Mg/Softgels

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Spain

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Country
Georgia Environmental
Not Confirmed
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Georgia Environmental
Not Confirmed

Omega-3

Brand Name : Omacor 1000Mg 100 Softgels

Dosage Form : Softgels

Dosage Strength : 1000 Mg/Softgels

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Spain

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Country
Georgia Environmental
Not Confirmed
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Georgia Environmental
Not Confirmed

Omega-3

Brand Name : Omega 3 Strides 1000Mg 100 Softgels Efg

Dosage Form : Softgels

Dosage Strength : 1000 Mg/Softgels

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Spain

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Country
Georgia Environmental
Not Confirmed
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Georgia Environmental
Not Confirmed

Omega-3

Brand Name : Omega 3 Ratiopharm 1000Mg 28 Softgels (Bottle) Efg

Dosage Form : Softgels

Dosage Strength : 1000 Mg/Softgels

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Spain

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Europe

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01

Orifarm AS

Denmark
Georgia Environmental
Not Confirmed
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Orifarm AS

Denmark
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Georgia Environmental
Not Confirmed

Omega-3 acid ethyl esters 90

Brand Name : Omacor

Dosage Form : Kapsel, myk

Dosage Strength : 1000 mg

Packaging : Boks av plast 100item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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02

Country
Georgia Environmental
Not Confirmed
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Georgia Environmental
Not Confirmed

Omega-3

Brand Name : Omega 3 Aristo 1000Mg 100 Softgels (250Ml) Efg

Dosage Form : Softgels

Dosage Strength : 1000 Mg/Softgels

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Spain

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Country
Georgia Environmental
Not Confirmed
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Georgia Environmental
Not Confirmed

Omega-3

Brand Name : Omega 3 Teva 1000Mg 100 Softgels (Bottle) Efg

Dosage Form : Softgels

Dosage Strength : 1000 Mg/Softgels

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Spain

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04

Country
Georgia Environmental
Not Confirmed
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Georgia Environmental
Not Confirmed

Omega-3

Brand Name : Omega 3 Kern Pharma 1,000Mg 100 Softgels Efg

Dosage Form : Softgels

Dosage Strength : 1000 Mg/Softgels

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Spain

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Country
Georgia Environmental
Not Confirmed
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Georgia Environmental
Not Confirmed

Omega-3

Brand Name : Omacor 1000Mg 100 Softgels

Dosage Form : Softgels

Dosage Strength : 1000 Mg/Softgels

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Spain

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06

Country
Georgia Environmental
Not Confirmed
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Georgia Environmental
Not Confirmed

Omega-3

Brand Name : Omega 3 Tarbis 1000Mg 100 Softgels Efg

Dosage Form : Softgels

Dosage Strength : 1000 Mg/Softgels

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Spain

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07

Country
Georgia Environmental
Not Confirmed
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Georgia Environmental
Not Confirmed

Omega-3

Brand Name : Omega 3 Ratiopharm 1000Mg 28 Softgels (Bottle) Efg

Dosage Form : Softgels

Dosage Strength : 1000 Mg/Softgels

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Spain

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Country
Georgia Environmental
Not Confirmed
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Georgia Environmental
Not Confirmed

Omega-3

Brand Name : Omega 3 Stada 1000Mg 28 Softgels Efg

Dosage Form : Softgels

Dosage Strength : 1000 Mg/Softgels

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Spain

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09

Country
Georgia Environmental
Not Confirmed
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Georgia Environmental
Not Confirmed

Omega-3

Brand Name : Omega 3 Aristo 1000Mg 28 Softgels (75Ml) Efg

Dosage Form : Softgels

Dosage Strength : 1000 Mg/Softgels

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Spain

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Country
Georgia Environmental
Not Confirmed
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Country
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Georgia Environmental
Not Confirmed

Omega-3

Brand Name : Omega 3 Teva 1000Mg 28 Softgels (Bottle) Efg

Dosage Form : Softgels

Dosage Strength : 1000 Mg/Softgels

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Spain

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South Africa

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Georgia Environmental
Not Confirmed
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Georgia Environmental
Not Confirmed

Omega-3 fatty acids

Brand Name : Nutriflex Omega Plus

Dosage Form : INF

Dosage Strength : 4g/1000ml

Packaging : 1250X1g/1000ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Georgia Environmental
Not Confirmed
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Georgia Environmental
Not Confirmed

Omega-3 fatty acids

Brand Name : Nutriflex Omega Plus

Dosage Form : INF

Dosage Strength : 4g/1000ml

Packaging : 1875X1g/1000ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Georgia Environmental
Not Confirmed
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Georgia Environmental
Not Confirmed

Omega-3 fatty acids

Brand Name : Nutriflex Omega Specialized

Dosage Form : INF

Dosage Strength : 4g/1000ml

Packaging : 625X1g/1000ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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04

Georgia Environmental
Not Confirmed
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Georgia Environmental
Not Confirmed

Omega-3 fatty acids

Brand Name : Nutriflex Omega Specialized

Dosage Form : INF

Dosage Strength : 4g/1000ml

Packaging : 1250X1g/1000ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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05

Georgia Environmental
Not Confirmed
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Georgia Environmental
Not Confirmed

Omega-3 fatty acids

Brand Name : Nutriflex Omega Specialized

Dosage Form : INF

Dosage Strength : 4g/1000ml

Packaging : 1875X1g/1000ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Listed Dossiers

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01

Kyiv Vitamin

Ukraine
Georgia Environmental
Not Confirmed
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Kyiv Vitamin

Ukraine
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Georgia Environmental
Not Confirmed

Omega-3 fatty acids

Brand Name : Epadol Neo

Dosage Form : Soft Capsule

Dosage Strength : 1000MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Ukraine

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01

Kyiv Vitamin

Ukraine
Georgia Environmental
Not Confirmed
arrow

Kyiv Vitamin

Ukraine
arrow
Georgia Environmental
Not Confirmed

Omega-3 fatty acids

Dosage : Soft Capsule

Dosage Strength : 1000MG

Brand Name : Epadol Neo

Approval Date :

Application Number :

Registration Country : Ukraine

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