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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 409beon-gil, Wolgot-myeon, Gimpo-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,...

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.

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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Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
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Details:
Bioma Probiotics is a potent blend of prebiotics, probiotics, and postbiotics to help nourish the gut, reduce bloating, enhance energy, and support weight management.
Lead Product(s): Lactobacillus Acidophilus,Bifidobacterium Lactis,Saccharomyces Boulardii
Therapeutic Area: Gastroenterology Brand Name: Bioma Probiotics
Study Phase: Approved FDFProduct Type: Probiotic
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 23, 2025

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Lead Product(s) : Lactobacillus Acidophilus,Bifidobacterium Lactis,Saccharomyces Boulardii
Therapeutic Area : Gastroenterology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Bioma Probiotics Officially Launches: A Revolutionary Step Toward Total Gut Health
Details : Bioma Probiotics is a potent blend of prebiotics, probiotics, and postbiotics to help nourish the gut, reduce bloating, enhance energy, and support weight management.
Product Name : Bioma Probiotics
Product Type : Probiotic
Upfront Cash : Inapplicable
June 23, 2025

Details:
Bifidobacterium breve is a drug candidate, which is currently being evaluated in clinical studies for the treatment of Constipation.
Lead Product(s): Bifidobacterium Breve,Lactobacillus Acidophilus,Lacticaseibacillus Rhamnosus,Saccharomyces Boulardii,Alpha-Amylase
Therapeutic Area: Gastroenterology Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Microorganism
Sponsor: Biohm Health, LLC
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 14, 2022

Lead Product(s) : Bifidobacterium Breve,Lactobacillus Acidophilus,Lacticaseibacillus Rhamnosus,Saccharomyces Boulardii,Alpha-Amylase
Therapeutic Area : Gastroenterology
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Biohm Health, LLC
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Bifidobacterium breve is a drug candidate, which is currently being evaluated in clinical studies for the treatment of Constipation.
Product Name : Undisclosed
Product Type : Microorganism
Upfront Cash : Inapplicable
November 14, 2022

Details:
Lactobacillus Paracasei is a Probiotic drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Irritable Bowel Syndrome.
Lead Product(s): Lactobacillus Paracasei,Lactobacillus Plantarum,Lactobacillus Acidophilus,Lactobacillus Delbrueckii Subsp Bulgaricus,Bifidobacteria Longum,Bifidobacteria Infantis,Bifidobacteria Breve
Therapeutic Area: Gastroenterology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Probiotic
Sponsor: Department of Gastroenterology, Govt. Medical College, Kozhikode, Kerala, India
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 10, 2015

Lead Product(s) : Lactobacillus Paracasei,Lactobacillus Plantarum,Lactobacillus Acidophilus,Lactobacillus Delbrueckii Subsp Bulgaricus,Bifidobacteria Longum,Bifidobacteria Infantis,Bifidobacteria Breve
Therapeutic Area : Gastroenterology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Department of Gastroenterology, Govt. Medical College, Kozhikode, Kerala, India
Deal Size : Inapplicable
Deal Type : Inapplicable
Study to Determine Efficacy of Probiotics in Irritable Bowel Syndrome
Details : Lactobacillus Paracasei is a Probiotic drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Irritable Bowel Syndrome.
Product Name : Undisclosed
Product Type : Probiotic
Upfront Cash : Inapplicable
September 10, 2015

Details:
Lactobacillus acidophilus is a drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Fever.
Lead Product(s): Lactobacillus Acidophilus,Bifidobacterium Lactis
Therapeutic Area: Immunology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Probiotic
Sponsor: International Flavors and Fragrances
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 31, 2015

Lead Product(s) : Lactobacillus Acidophilus,Bifidobacterium Lactis
Therapeutic Area : Immunology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : International Flavors and Fragrances
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Lactobacillus acidophilus is a drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Fever.
Product Name : Undisclosed
Product Type : Probiotic
Upfront Cash : Inapplicable
August 31, 2015

Details:
Lactobacillus Paracasei is a Probiotic drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Liver Cirrhosis.
Lead Product(s): Lactobacillus Paracasei,Lactobacillus Plantarum,Lactobacillus Acidophilus,Lactobacillus Delbrueckii Subsp Bulgaricus,Bifidobacteria Longum,Bifidobacteria Infantis,Bifidobacteria Breve
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Probiotic
Sponsor: VSL Pharmaceuticals
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 05, 2012

Lead Product(s) : Lactobacillus Paracasei,Lactobacillus Plantarum,Lactobacillus Acidophilus,Lactobacillus Delbrueckii Subsp Bulgaricus,Bifidobacteria Longum,Bifidobacteria Infantis,Bifidobacteria Breve
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : VSL Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
VSL#3 and Spontaneous Bacterial Peritonitis
Details : Lactobacillus Paracasei is a Probiotic drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Liver Cirrhosis.
Product Name : Undisclosed
Product Type : Probiotic
Upfront Cash : Inapplicable
October 05, 2012

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Details:
Lactobacillus Paracasei is a Probiotic drug candidate, which is currently being evaluated in phase II/ phase III clinical studies for the treatment of Hepatic Encephalopathy.
Lead Product(s): Lactobacillus Paracasei,Lactobacillus Plantarum,Lactobacillus Acidophilus,Lactobacillus Delbrueckii Subsp Bulgaricus,Bifidobacteria Longum,Bifidobacteria Infantis,Bifidobacteria Breve
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase II/ Phase IIIProduct Type: Probiotic
Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 26, 2010

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Lead Product(s) : Lactobacillus Paracasei,Lactobacillus Plantarum,Lactobacillus Acidophilus,Lactobacillus Delbrueckii Subsp Bulgaricus,Bifidobacteria Longum,Bifidobacteria Infantis,Bifidobacteria Breve
Therapeutic Area : Neurology
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Post Graduate Institute of Medical Education and Research, Chandigarh
Deal Size : Inapplicable
Deal Type : Inapplicable
Secondary Prophylaxis of Hepatic Encephalopathy With a Probiotic Preparation
Details : Lactobacillus Paracasei is a Probiotic drug candidate, which is currently being evaluated in phase II/ phase III clinical studies for the treatment of Hepatic Encephalopathy.
Product Name : Undisclosed
Product Type : Probiotic
Upfront Cash : Inapplicable
April 26, 2010

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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 : 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 :
Registration Country : India
Brand Name :
Dosage Form : Capsule
Dosage Strength : 1Billion
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India

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Regulatory Info :
Registration Country : India
Lactobacillus Acidophilus; Lactobacillus Plantarum; Lactobacillus Rhamnosus; Lactobacillus Casei
Brand Name :
Dosage Form : Capsule
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India

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Regulatory Info :
Registration Country : Germany
Lactobacillus Acidophilus; Lactobacillus Fermentum; Lactobacillus Plantarum; Lactobacillus Rhamnosus
Brand Name : Compliflora femina
Dosage Form : Capsule
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Germany

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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 :
Registration Country : India
Lactobacillus Acidophilus; Lactobacillus Rhamnosus; Bifidobacterium Longum; Bacillus Coagulans; Saccharomyces Boulardii
Brand Name : Sporlac Plus
Dosage Form : Sachet
Dosage Strength : 1.25B CFU/1G
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India

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