Find Ethiodized Oil manufacturers, exporters & distributors on PharmaCompass

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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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CEP/COS

CEP/COS Certifications

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JDMF

JDMFs Filed

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EU WC

EU WC

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NDC API

NDC API

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VMF

NDC API

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REF. STANDARDS OR IMPURITIES

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EDQM

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USP

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JP

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Others

FINISHED DOSAGE FORMULATIONS

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Europe

Europe

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Australia

Australia

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Listed Dossiers

Listed Dossiers

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FDF Dossiers

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PATENTS & EXCLUSIVITIES

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US Patents

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US Exclusivities

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Health Canada Patents

API REF. PRICE (USD/KG)

GLOBAL SALES INFORMATION

US Medicaid

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Regulatory FDF Prices

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Chemistry

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USDMF

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 37450

Submission : 2022-08-30

Status : Active

Type : II

Biophore

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PEGS Boston Summit
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PEGS Boston Summit
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GDUFA

DMF Review : Complete

Rev. Date : 2016-01-26

Pay. Date : 2015-08-07

DMF Number : 29336

Submission : 2015-04-27

Status : Active

Type : II

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KDMF

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BioProcess International Europe
Not Confirmed
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BioProcess International Europe
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Iodized oil (iodinated fatty acid ethyl ester derived from poppy seeds)

Registrant Name : Dongkook Pharmaceutical Co., Ltd.

Registration Date : 2020-02-03

Registration Number : 20200203-210-J-549

Manufacturer Name : Shanghai Wonder Pharmaceutic...

Manufacturer Address : No.298, Huachuang Road, Jinshan District, Shanghai, 201512, China

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02

BioProcess International Europe
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BioProcess International Europe
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Iodized oil (iodinated fatty acid ethyl ester derived from poppy seeds)

Registrant Name : Sampoong Finechem Co., Ltd.

Registration Date : 2021-10-18

Registration Number : 20200203-210-J-549(1)

Manufacturer Name : Shanghai Wonder Pharmaceutic...

Manufacturer Address : No.298, Huachuang Road, Jinshan District, Shanghai, 201512, China

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Listed Suppliers

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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Digital Content Digital Content

Ethiodized Oil

About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...

Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among API companies. It consistently ranks among the top 10 US DMF filers and has obtained over 150 patents worldwide in process and polymorph areas. Biophore's facilities have an impressive track record of successful audits by regulatory bodies such as USFDA, EMEA, ANVISA, COFEPRIS, and WHO GMP.
Biophore
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FDA Orange Book

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01

GUERBET

France
AAPS National Biotech
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GUERBET

France
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AAPS National Biotech
Not Confirmed

ETHIODIZED OIL

Brand Name : LIPIODOL

Dosage Form : OIL;INTRALYMPHATIC, INTRAUTERINE

Dosage Strength : EQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)

Approval Date : 1982-01-01

Application Number : 9190

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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