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Saxagliptin Hydrate
FDF Dossiers

Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.

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IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.

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IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.

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medac CDMO: Tailored CDMO services for injectables in syringes, cartridges & vials – aseptic, reliable, flexible and a solution ahead.

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Coral

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ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.

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Saxagliptin Hydrate

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ACTIVE PHARMA INGREDIENTS

29 API Suppliers, 7 USDMF, 1 CEP/COS, 1 JDMF, 4 EU WC, 4 KDMF, 5 NDC API, 18 Listed Suppliers, $ API Reference Price

29 API Suppliers
7 USDMF
1 CEP/COS
1 JDMF
4 EU WC
4 KDMF
5 NDC API
18 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

55 Drugs in Development

55 Drugs in Development

INTERMEDIATES

14 Intermediate Suppliers

14 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

31 FDF Dossiers, 7 FDA Orange Book, 18 Europe, 4 Australia, 2 South Africa

31 FDF Dossiers
7 FDA Orange Book
18 Europe
4 Australia
2 South Africa

DIGITAL CONTENT

45 News #PharmaBuzz

45 News #PharmaBuzz

GLOBAL SALES INFORMATION

14 Regulatory FDF Prices, 30 Annual Reports

14 Regulatory FDF Prices
30 Annual Reports

MARKET PLACE

8 APIs, 2 FDF Dossiers

8 APIs
2 FDF Dossiers

REF. STANDARDS & IMPURITIES

1 Others

1 Others

$ API Ref.Price (USD/KG) : 13,558 Xls

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31 All

01 3Amneal Pharmaceuticals

02 24AstraZeneca

03 2Lupin Ltd

04 1MSN Laboratories

05 1Par Pharmaceutical

filter Dosage Reset all filters

31 All

01 10Antic-calc Tablet, Film Coated

02 4Film Coated Tablet

03 1Saxagliptin + Metformin 2.5 + 1.000Mg 56 Combined Oral Use

04 1Saxagliptin + Metformin 2.5 + 850Mg 56 Combined Oral Use

05 1Saxagliptin 2,5Mg 28 Combined Oral Use

06 1Saxagliptin 5Mg 28 Combined Oral Use

07 2TAB

08 3TABLET, EXTENDED RELEASE;ORAL

09 3TABLET; ORAL

10 1TABLET;ORAL

11 4tablet

filter Regulatory Info Reset all filters

31 All

01 2Allowed

02 2Approved

03 2Originator

04 25Blank

filter Brand Name Reset all filters

31 All

01 1DAPAGLIFLOZIN AND SAXAGLIPTIN

02 2DAPAGLIFLOZIN AND SAXAGLIPTIN MONOHYDRATE

03 6Komboglyze

04 14Onglyza

05 1Onglyza 2,5

06 1Onglyza 5

07 2Qtern

08 1SAXAGLIPTIN

09 3SAXAGLIPTIN;METFORMIN HYDROCHLORIDE

filter Country Reset all filters

31 All

01 4Australia

02 4Italy

03 10Norway

04 2South Africa

05 2Sweden

06 2Switzerland

07 7USA

List of Suppliers

Product Main Page

01

Amneal Pharmaceuticals

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Amneal Pharmaceuticals

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Regulatory Info :

Registration Country : USA

SAXAGLIPTIN; METFORMIN HYDROCHLORIDE

Brand Name : SAXAGLIPTIN;METFORMIN HYDROCHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 5MG;500MG

Packaging :

Approval Date :

Application Number : 205942

Regulatory Info :

Registration Country : USA

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02

Amneal Pharmaceuticals

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Amneal Pharmaceuticals

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Regulatory Info :

Registration Country : USA

SAXAGLIPTIN; METFORMIN HYDROCHLORIDE

Brand Name : SAXAGLIPTIN;METFORMIN HYDROCHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 2.5MG;1000MG

Packaging :

Approval Date :

Application Number : 205942

Regulatory Info :

Registration Country : USA

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03

Amneal Pharmaceuticals

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Amneal Pharmaceuticals

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Regulatory Info :

Registration Country : USA

SAXAGLIPTIN; METFORMIN HYDROCHLORIDE

Brand Name : SAXAGLIPTIN;METFORMIN HYDROCHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 5MG;1000MG

Packaging :

Approval Date :

Application Number : 205942

Regulatory Info :

Registration Country : USA

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04

AstraZeneca

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AstraZeneca

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Regulatory Info :

Registration Country : Italy

saxagliptin

Brand Name : Onglyza

Dosage Form : Saxagliptin 5Mg 28 Combined Oral Use

Dosage Strength : 28 cpr riv 5 mg

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Approval Date :

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Regulatory Info :

Registration Country : Italy

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05

AstraZeneca

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AstraZeneca

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Regulatory Info :

Registration Country : Italy

saxagliptin

Brand Name : Onglyza

Dosage Form : Saxagliptin 2,5Mg 28 Combined Oral Use

Dosage Strength : 28 cpr riv 2.5 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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06

AstraZeneca

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AstraZeneca

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Regulatory Info :

Registration Country : Italy

saxagliptin; Metformin

Brand Name : Komboglyze

Dosage Form : Saxagliptin + Metformin 2.5 + 850Mg 56 Combined Oral Use

Dosage Strength : 56 cpr riv 2.5 mg + 850 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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07

AstraZeneca

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AstraZeneca

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Regulatory Info :

Registration Country : Italy

saxagliptin; Metformin

Brand Name : Komboglyze

Dosage Form : Saxagliptin + Metformin 2.5 + 1.000Mg 56 Combined Oral Use

Dosage Strength : 56 cpr riv 2.5 mg + 1,000 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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08

AstraZeneca

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AstraZeneca

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Regulatory Info :

Registration Country : Norway

saxagliptin

Brand Name : Onglyza

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 2.5 mg

Packaging : Calendar Gasket

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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09

AstraZeneca

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AstraZeneca

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Regulatory Info :

Registration Country : Norway

saxagliptin

Brand Name : Onglyza

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 2.5 mg

Packaging : Calendar Gasket

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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10

AstraZeneca

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AstraZeneca

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Regulatory Info :

Registration Country : Norway

saxagliptin

Brand Name : Onglyza

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 5 mg

Packaging : Calendar Gasket

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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Product Web Link

Digital Content

Corporate PDF

11

AstraZeneca

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AstraZeneca

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Regulatory Info :

Registration Country : Norway

saxagliptin

Brand Name : Onglyza

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 5 mg

Packaging : Calendar Gasket

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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Product Web Link

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12

AstraZeneca

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AstraZeneca

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Regulatory Info :

Registration Country : Norway

Metformin; saxagliptin

Brand Name : Komboglyze

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 2.5MG; 1000MG

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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13

AstraZeneca

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AstraZeneca

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Regulatory Info :

Registration Country : Norway

Metformin; saxagliptin

Brand Name : Komboglyze

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 2.5MG; 1000MG

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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14

AstraZeneca

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AstraZeneca

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Regulatory Info :

Registration Country : Norway

Metformin; saxagliptin

Brand Name : Komboglyze

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 2.5MG; 850MG

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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15

AstraZeneca

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AstraZeneca

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Regulatory Info :

Registration Country : Norway

Metformin; saxagliptin

Brand Name : Komboglyze

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 2.5MG; 850MG

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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16

AstraZeneca

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AstraZeneca

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Regulatory Info :

Registration Country : Norway

saxagliptin; Dapagliflozin

Brand Name : Qtern

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 05MG; 10MG

Packaging : Calendar Gasket

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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17

Lupin Ltd

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Lupin Ltd

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Regulatory Info :

Registration Country : USA

DAPAGLIFLOZIN, SAXAGLIPTIN MONOHYDRATE

Brand Name : DAPAGLIFLOZIN AND SAXAGLIPTIN MONOHYDRATE

Dosage Form : TABLET; ORAL

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number : 211532

Regulatory Info :

Registration Country : USA

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18

Lupin Ltd

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Lupin Ltd

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Regulatory Info :

Registration Country : USA

DAPAGLIFLOZIN, SAXAGLIPTIN MONOHYDRATE

Brand Name : DAPAGLIFLOZIN AND SAXAGLIPTIN MONOHYDRATE

Dosage Form : TABLET; ORAL

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number : 211532

Regulatory Info :

Registration Country : USA

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19

MSN Laboratories

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MSN Laboratories

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Registration Country : USA

DAPAGLIFLOZIN; SAXAGLIPTIN

Brand Name : DAPAGLIFLOZIN AND SAXAGLIPTIN

Dosage Form : TABLET; ORAL

Dosage Strength : 10MG/5MG

Packaging :

Approval Date :

Application Number : 211533

Regulatory Info :

Registration Country : USA

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20

Par Pharmaceutical

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Par Pharmaceutical

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Regulatory Info :

Registration Country : USA

SAXAGLIPTIN

Brand Name : SAXAGLIPTIN

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number : 205959

Regulatory Info :

Registration Country : USA

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