Synopsis
Synopsis
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CEP/COS
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JDMF
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EU WC
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NDC API
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VMF
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EDQM
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USP
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JP
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Others
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FDA Orange Book
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Canada
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Australia
DRUG PRODUCT COMPOSITIONS
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US Patents
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40647
Submission : 2024-10-18
Status : Active
Type : II

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Sigma-Aldrich empowers scientific discovery with top-quality solutions to accelerate research, innovation, and better health worldwide.
Registrant Name : Hyundai Pharmaceutical Co., Ltd.
Registration Date : 2013-08-30
Registration Number : 20130830-146-I-87-07
Manufacturer Name : Sacco SRL
Manufacturer Address : Cadorago (CO) - Via Manzoni 29/A, Italy.
Registrant Name : Cell Biotech Co., Ltd.
Registration Date : 2012-08-24
Registration Number : 20120824-146-I-197-03
Manufacturer Name : Cell Biotech Co., Ltd.
Manufacturer Address : 50, Aegibong-ro 409beongil, Wolgot-myeon, Gimpo-si, Gyeonggi-do

Registrant Name : Chong Kun Dang Bio Co., Ltd.
Registration Date : 2021-11-30
Registration Number : 20211130-146-I-643-08
Manufacturer Name : Chong Kun Dang Bio Co., Ltd.
Manufacturer Address : 292 Sinwon-ro, Danwon-gu, Ansan-si, Gyeonggi-do.

Registrant Name : Chong Kun Dang Bio Co., Ltd.
Registration Date : 2022-07-13
Registration Number : 20220713-146-I-644-09
Manufacturer Name : Chong Kun Dang Bio Co., Ltd....
Manufacturer Address : 292 Sinwon-ro, Danwon-gu, Ansan-si, Gyeonggi-do. @292 Sinwon-ro, Danwon-gu, Ansan-si,...

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]About the Company : Established in 1991, Pharm-Rx is an importer and distributor of active ingredients serving the pharmaceutical, nutritional supplement, and food industries. The company follows a hi...
About the Company : Newgen Biotech® USA provides a global platform for accessing the highest quality ingredients and blends. We source our products from manufacturing sites that adhere to ISO9001, IS...

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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
| Importing Country | Total Quantity (KGS) |
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Number of Transactions |
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Regulatory Info : Marketed
Registration Country : Norway
Estriol; Lactobacillus acidophilus, lyophilized
Brand Name : Gynoflor
Dosage Form : Vaginal Tablet
Dosage Strength : 0.03mg; 50mg
Packaging :
Approval Date :
Application Number :
Regulatory Info : Marketed
Registration Country : Norway

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Regulatory Info : Not Marketed
Registration Country : Norway
Estriol; Lactobacillus acidophilus, lyophilized
Brand Name : Gynoflor
Dosage Form : Vaginal Tablet
Dosage Strength : 0.03mg; 50mg
Packaging :
Approval Date :
Application Number :
Regulatory Info : Not Marketed
Registration Country : Norway

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Regulatory Info : Prescription
Registration Country : Denmark
Estriol; Lactobacillus Acidophilus
Brand Name : Gynoflor
Dosage Form : Vaginal Tablet
Dosage Strength : 0.03mg; 50mg
Packaging :
Approval Date : 02-09-2022
Application Number : 28106517920
Regulatory Info : Prescription
Registration Country : Denmark

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Regulatory Info : Cancelled
Registration Country : Spain
Brand Name : Fermexal Oral Powder
Dosage Form : Oral Powder
Dosage Strength :
Packaging :
Approval Date : 01-07-1953
Application Number : 19461
Regulatory Info : Cancelled
Registration Country : Spain

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Regulatory Info :
Registration Country : Moldova
Lactobacillus acidophilus; Bifidobacterium infantis; Enterococcus faecium
Brand Name : Linex®
Dosage Form : Capsule
Dosage Strength : 1.2x10^7CFU
Packaging :
Approval Date : 25-03-2022
Application Number :
Regulatory Info :
Registration Country : Moldova

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Regulatory Info :
Registration Country : Moldova
Lactobacillus acidophilus; Bifidobacterium animalis subsp. of milk
Brand Name : Linex® forte
Dosage Form : Capsule
Dosage Strength : 2x10^9 CFU
Packaging :
Approval Date : 03-07-2018
Application Number :
Regulatory Info :
Registration Country : Moldova

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Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Lacteol Powder For Oral Suspension
Dosage Form : Oral Suspension
Dosage Strength :
Packaging :
Approval Date : 18-11-2003
Application Number : 65790
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Lacteol Capsules
Dosage Form : Capsule
Dosage Strength :
Packaging :
Approval Date : 18-11-2003
Application Number : 65791
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info :
Registration Country : Moldova
Lactobacillus rhamnosus; Lactobacillus acidophilus
Brand Name : Lacidofil®-WM
Dosage Form : Capsule
Dosage Strength : 1.9 x 10^9 CFU/ 0.1 x 10^9 CFU
Packaging :
Approval Date : 14-12-2020
Application Number :
Regulatory Info :
Registration Country : Moldova

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