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Drug Product Composition: Octreotide Acetate

Octreotide Acetate

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ACTIVE PHARMA INGREDIENTS

44 API Suppliers, 27 USDMF, 6 CEP/COS, 4 JDMF, 5 EU WC, 1 KDMF, 20 NDC API, 25 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

23 Drugs in Development

23 Drugs in Development

FINISHED DOSAGE FORMULATIONS

238 FDF Dossiers, 61 FDA Orange Book, 92 Europe, 11 Canada, 48 Australia, 8 South Africa, 18 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - EQ 0.05MG BASE/ML, INJECTABLE;INJECTION - EQ 0.1MG BASE/ML, INJECTABLE;INJECTION - EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - EQ 0.5MG BASE/ML, INJECTABLE;INJECTION - EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;SUBCUTANEOUS - 7MG/2.8ML (2.5MG/ML)

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 13 SPI Pharma, 1 Pfanstiehl, 2 Actylis, 1 BASF, 1 Finar, 2 Gangwal Chemicals, 1 Ingredion Pharma Solutions, 2 Kerry, 2 Microlex e.U, 1 Pluviaendo, 3 Roquette, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 1 Sigachi Industries

EXCIPIENTS BY APPLICATIONS

17 Fillers, Diluents & Binders, 10 Chewable & Orodispersible Aids, 9 Direct Compression, 9 Taste Masking, 7 Parenteral, 3 Disintegrants & Superdisintegrants, 3 Co-Processed Excipients, 3 Granulation, 2 API Stability Enhancers, 1 Thickeners and Stabilizers, 1 Topical

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 38 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 79 Finished Drug Prices, 10 Annual Reports

MARKET PLACE

15 APIs, 15 FDF Dossiers

PATENTS & EXCLUSIVITIES

15 US Patents, 1 US Exclusivities

REF. STANDARDS & IMPURITIES

2 USP, 6 Others

$ Xls

Filters

Xls

USFDA APPLICATION NUMBER - 19667 / DOSAGE - INJECTABLE;INJECTION - EQ 0.05MG BASE/ML

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTREOTIDE ACETATE(UNII: 75R0U2568I) (OCTREOTIDE - UNII:RWM8CCW8GP)	OCTREOTIDE	1000ug in 1 \| 200ug in 1

Inactive Ingredients

Ingredient Name	Heritage Pharmaceuticals Inc.	Sagent Pharmaceuticals	Teva Parenteral Medicines, Inc.	Sandoz Inc	Sun Pharmaceutical Industries Limited
ACETIC ACID(Q40Q9N063P)
LACTIC ACID(33X04XA5AT)
MANNITOL(3OWL53L36A)
PHENOL(339NCG44TV)
SODIUM ACETATE(4550K0SC9B)
SODIUM BICARBONATE(8MDF5V39QO)
sodium chloride(451W47IQ8X)
WATER(059QF0KO0R)

Drug Product Composition: Octreotide Acetate

Octreotide Acetate

Octreotide Acetate

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

44 API Suppliers

27 USDMF

6 CEP/COS

4 JDMF

5 EU WC

1 KDMF

20 NDC API

25 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

23 Drugs in Development

FINISHED DOSAGE FORMULATIONS

238 FDF Dossiers

61 FDA Orange Book

92 Europe

11 Canada

48 Australia

8 South Africa

18 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - EQ 0.05MG BASE/ML

INJECTABLE;INJECTION - EQ 0.1MG BASE/ML

INJECTABLE;INJECTION - EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - EQ 0.5MG BASE/ML

INJECTABLE;INJECTION - EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SOLUTION;SUBCUTANEOUS - 7MG/2.8ML (2.5MG/ML)

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc

13 SPI Pharma

1 Pfanstiehl

2 Actylis

1 BASF

1 Finar

2 Gangwal Chemicals

1 Ingredion Pharma Solutions

2 Kerry

2 Microlex e.U

1 Pluviaendo

3 Roquette

1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

1 Sigachi Industries

EXCIPIENTS BY APPLICATIONS

17 Fillers, Diluents & Binders

10 Chewable & Orodispersible Aids

9 Direct Compression

9 Taste Masking

7 Parenteral

3 Disintegrants & Superdisintegrants

3 Co-Processed Excipients

3 Granulation

2 API Stability Enhancers

1 Thickeners and Stabilizers

1 Topical

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow

38 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions

79 Finished Drug Prices

10 Annual Reports

MARKET PLACE

15 APIs

15 FDF Dossiers

PATENTS & EXCLUSIVITIES

15 US Patents

1 US Exclusivities

REF. STANDARDS & IMPURITIES

2 USP

6 Others

Filters

INJECTABLE;INJECTION - EQ 0.2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

INJECTABLE;INJECTION - EQ 1MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons