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Fresenius Medical Care De Mexico
FDF Dossiers

Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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HealthTech BioActives, leading globally in Flavonoids and Vitamin B12 Derivatives.

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

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Aspen API. More than just an API™

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FAMAR CDMO- From early development to commercial manufacturing.

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Fresenius Medical Care de Mexico

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FINISHED DOSAGE FORMULATIONS

42 FDF Dossiers, 25 Europe, 17 Canada

42 FDF Dossiers
25 Europe
17 Canada

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42 All

01 3CALCIUM CHLORIDE

02 1Calcium Acetate (Anhydrous)

03 1Calcium Acetate Hydrated; Magnesium Carbonate

04 1Calcium Chloride Dihydrate

05 1Calcium Chloride Dihydrate; Potassium Chloride; Magnesium Chloride Hexahydrate; Sodium Chloride; Sodium Lactate Solution (repeated)

06 2Calcium Polystyrene Sulfonate

07 3DEXTROSE

08 6Glucose (Anhydrous); Calcium Chloride Dihydrate; Magnesium Chloride Hexahydrate; Sodium Chloride; Sodium Lactate

09 5Glucose Monohydrate; Calcium Chloride Dihydrate; Magnesium Chloride Hexahydrate; Sodium Chloride; Sodium Lactate Solution

10 2Glucose Monohydrate; Calcium Chloride Dihydrate; Potassium Chloride; Magnesium Chloride Hexahydrate; Sodium (S)-Lactate Solution; Sodium Chloride

11 3Glucose Monohydrate; Calcium Chloride Dihydrate; Potassium Chloride; Magnesium Chloride Hexahydrate; Sodium Chloride; Sodium Bicarbonate

12 1Iron Sucrose

13 3MAGNESIUM CHLORIDE

14 1Natriumv?tekarbonat

15 2SODIUM BICARBONATE

16 3SODIUM CHLORIDE

17 3SODIUM LACTATE

18 1Sodium Citrate (Dihydrate)

filter Applicant Reset all filters

42 All

01 17FRESENIUS MEDICAL CARE CANADA INC

02 20Fresenius Medical Care Deutschland Gmbh

03 5Fresenius Medical Care Nephrologica Deutschland Gmbh

filter Dosage Form Reset all filters

42 All

01 17Dialysis Solution

02 2Film Coated Tablet

03 2Infusion Solution

04 2POWDER FOR SOLUTION

05 2Powder For Oral/Rectal Suspension

06 15SOLUTION

07 1Solution For Injection

08 1Tablet

filter Dosage Reset all filters

42 All

01 30.1017G/L

02 30.1838G/L

03 11000mg

04 1100mmol/l

05 1136mmol/l

06 115g

07 116.5G/L

08 120mg/ml

09 125G/L

10 33.925G/L

11 1435mg;235mg

12 146.75G/L

13 35.64G/L

14 1650G/BAG

15 1660mg

16 1900G/BAG

17 18Blank

filter Country Reset all filters

42 All

01 17Canada

02 25Sweden

List of Suppliers

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01

Brand Name : Phosphosorb

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Brand Name : Phosphosorb

PREP

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Regulatory Info : Deregistered

Registration Country : Sweden

Calcium Acetate (Anhydrous)

Fresenius Medical Care de Mexico

Dosage Form : Film Coated Tablet

Brand Name : Phosphosorb

Dosage Strength : 660mg

Packaging :

Approval Date : 05/10/2007

Application Number : 20070118000029

Regulatory Info : Deregistered

Registration Country : Sweden

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02

Brand Name : Unanswered

PREP

Not Confirmed

Brand Name : Unanswered

PREP

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Regulatory Info : Deregistered

Registration Country : Sweden

Calcium Acetate Hydrated; Calcium Acetate Hydrated; Magnesium Carbonate

Fresenius Medical Care de Mexico

Dosage Form : Film Coated Tablet

Brand Name : Unanswered

Dosage Strength : 435mg;235mg

Packaging :

Approval Date : 08/02/2008

Application Number : 20070427000086

Regulatory Info : Deregistered

Registration Country : Sweden

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03

Brand Name : BALANCE 1.5% GLUCOSE...

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Brand Name : BALANCE 1.5% GLUCOSE...

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Regulatory Info : Ethical

Registration Country : Canada

CALCIUM CHLORIDE

Fresenius Medical Care de Mexico

Dosage Form : SOLUTION

Brand Name : BALANCE 1.5% GLUCOSE, 1.2...

Dosage Strength : 0.1838G/L

Packaging :

Approval Date :

Application Number : 2261057

Regulatory Info : Ethical

Registration Country : Canada

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04

Brand Name : BALANCE 4.25% GLUCOS...

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Brand Name : BALANCE 4.25% GLUCOS...

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Regulatory Info : Ethical

Registration Country : Canada

CALCIUM CHLORIDE

Fresenius Medical Care de Mexico

Dosage Form : SOLUTION

Brand Name : BALANCE 4.25% GLUCOSE, 1....

Dosage Strength : 0.1838G/L

Packaging :

Approval Date :

Application Number : 2261065

Regulatory Info : Ethical

Registration Country : Canada

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05

Brand Name : BALANCE 2.3% GLUCOSE...

PREP

Not Confirmed

Brand Name : BALANCE 2.3% GLUCOSE...

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Regulatory Info : Ethical

Registration Country : Canada

CALCIUM CHLORIDE

Fresenius Medical Care de Mexico

Dosage Form : SOLUTION

Brand Name : BALANCE 2.3% GLUCOSE, 1.2...

Dosage Strength : 0.1838G/L

Packaging :

Approval Date :

Application Number : 2261073

Regulatory Info : Ethical

Registration Country : Canada

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06

Brand Name : Calrecia

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Brand Name : Calrecia

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Regulatory Info : Approved

Registration Country : Sweden

Calcium Chloride Dihydrate

Fresenius Medical Care de Mexico

Dosage Form : Infusion Solution

Brand Name : Calrecia

Dosage Strength : 100mmol/l

Packaging :

Approval Date : 08/02/2019

Application Number : 20170605000041

Regulatory Info : Approved

Registration Country : Sweden

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07

Brand Name : Dicalys 17

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Brand Name : Dicalys 17

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Regulatory Info : Deregistered

Registration Country : Sweden

Calcium Chloride Dihydrate; Potassium Chloride; Magnesium Chloride Hexahydrate; Sodium Chloride; Sodium Lactate Solution (repeated)

Fresenius Medical Care de Mexico

Dosage Form : Dialysis Solution

Brand Name : Dicalys 17

Dosage Strength :

Packaging :

Approval Date : 13/08/1999

Application Number : 19990813000190

Regulatory Info : Deregistered

Registration Country : Sweden

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08

Brand Name : Sorbisterite

PREP

Not Confirmed

Brand Name : Sorbisterite

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Regulatory Info : Deregistered

Registration Country : Sweden

Calcium Polystyrene Sulfonate

Fresenius Medical Care de Mexico

Dosage Form : Powder For Oral/Rectal S...

Brand Name : Sorbisterite

Dosage Strength : 15g

Packaging :

Approval Date : 02/07/2015

Application Number : 20101105000071

Regulatory Info : Deregistered

Registration Country : Sweden

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09

Brand Name : Sorbisterite

PREP

Not Confirmed

Brand Name : Sorbisterite

PREP

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Regulatory Info : Deregistered

Registration Country : Sweden

Calcium Polystyrene Sulfonate

Fresenius Medical Care de Mexico

Dosage Form : Powder For Oral/Rectal S...

Brand Name : Sorbisterite

Dosage Strength :

Packaging :

Approval Date : 01/06/2007

Application Number : 20061213000014

Regulatory Info : Deregistered

Registration Country : Sweden

Product
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10

Brand Name : BALANCE 1.5% GLUCOSE...

PREP

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Brand Name : BALANCE 1.5% GLUCOSE...

PREP

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Regulatory Info : Ethical

Registration Country : Canada

Fresenius Medical Care de Mexico

Dosage Form : SOLUTION

Brand Name : BALANCE 1.5% GLUCOSE, 1.2...

Dosage Strength : 16.5G/L

Packaging :

Approval Date :

Application Number : 2261057

Regulatory Info : Ethical

Registration Country : Canada

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