Methotrexate

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ACTIVE PHARMA INGREDIENTS

45 API Suppliers, 21 USDMF, 7 CEP/COS, 4 JDMF, 3 EU WC, 10 NDC API, 27 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

56 Drugs in Development

56 Drugs in Development

INTERMEDIATES

7 Intermediates Suppliers

7 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

653 FDF Dossiers, 128 FDA Orange Book, 358 Europe, 46 Canada, 55 Australia, 12 South Africa, 54 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - EQ 100MG BASE/VIAL, INJECTABLE;INJECTION - EQ 1GM BASE/VIAL, INJECTABLE;INJECTION - EQ 1GM BASE/40ML (EQ 25MG BASE/ML), INJECTABLE;INJECTION - EQ 2.5GM BASE/100ML (EQ 25MG BASE/ML), INJECTABLE;INJECTION - EQ 2.5MG BASE/ML, INJECTABLE;INJECTION - EQ 20MG BASE/VIAL, INJECTABLE;INJECTION - EQ 20MG BASE/2ML (EQ 10MG BASE/ML), INJECTABLE;INJECTION - EQ 25MG BASE/ML, INJECTABLE;INJECTION - EQ 500MG BASE/20ML (EQ 25MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - EQ 50MG BASE/VIAL, INJECTABLE;INJECTION - EQ 50MG BASE/2ML (EQ 25MG BASE/ML), SOLUTION;SUBCUTANEOUS - 10MG/0.4ML (10MG/0.4ML), SOLUTION;SUBCUTANEOUS - 12.5MG/0.5ML (12.5MG/0.5ML), SOLUTION;SUBCUTANEOUS - 15MG/0.6ML (15MG/0.6ML), SOLUTION;SUBCUTANEOUS - 17.5MG/0.7ML (17.5MG/0.7ML), SOLUTION;SUBCUTANEOUS - 20MG/0.8ML (20MG/0.8ML), SOLUTION;SUBCUTANEOUS - 22.5MG/ML (22.5MG/ML), SOLUTION;SUBCUTANEOUS - 25MG/1ML (25MG/1ML), SOLUTION;SUBCUTANEOUS - 7.5MG/0.3ML (7.5MG/0.3ML), TABLET;ORAL - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 4 SPI Pharma, 2 Seqens, 3 DKSH, 1 Pharm-RX Chemical, 5 Faran Shimi Pharmaceutical, 12 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 9 Actylis, 1 Aeon Procare, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 17 BASF, 1 Bioplus Life Sciences, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 3 Finar, 9 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 36 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 17 Roquette, 13 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 2 The Dow Chemical Company, 1 Valens Pharmachem, 3 Vasa Pharmachem

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60 Fillers, Diluents & Binders, 46 Coating Systems & Additives, 31 Direct Compression, 26 Controlled & Modified Release, 22 Thickeners and Stabilizers, 19 Disintegrants & Superdisintegrants, 19 Granulation, 18 Solubilizers, 17 Topical, 16 Co-Processed Excipients, 16 Lubricants & Glidants, 14 Parenteral, 12 Film Formers & Plasticizers, 11 Taste Masking, 8 Emulsifying Agents, 6 Chewable & Orodispersible Aids, 5 Empty Capsules, 5 API Stability Enhancers, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 4 Coloring Agents, 4 Rheology Modifiers

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USFDA APPLICATION NUMBER - 11719 / DOSAGE - INJECTABLE;INJECTION - EQ 50MG BASE/2ML (EQ 25MG BASE/ML)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METHOTREXATE SODIUM(UNII: 3IG1E710ZN) (METHOTREXATE - UNII:YL5FZ2Y5U1)	METHOTREXATE	25mg in 1

Inactive Ingredients

Ingredient Name	Hospira, Inc.	Mylan Institutional LLC	Pfizer Laboratories Div Pfizer Inc.	Sandoz Inc	Teva Parenteral Medicines, Inc.	ThyMoorgan GmbH Pharmazir & Co. K.G
HYDROCHLORIC ACID(QTT17582CB)
SODIUM CHLORIDE(451W47IQ8X)
SODIUM HYDROXIDE(55X04QC32I)
WATER(059QF0KO0R)

Drug Product Composition: Methotrexate

Methotrexate

Methotrexate

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

45 API Suppliers

21 USDMF

7 CEP/COS

4 JDMF

3 EU WC

10 NDC API

27 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

56 Drugs in Development

INTERMEDIATES

7 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

653 FDF Dossiers

128 FDA Orange Book

358 Europe

46 Canada

55 Australia

12 South Africa

54 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - EQ 100MG BASE/VIAL

INJECTABLE;INJECTION - EQ 1GM BASE/VIAL

INJECTABLE;INJECTION - EQ 1GM BASE/40ML (EQ 25MG BASE/ML)

INJECTABLE;INJECTION - EQ 2.5GM BASE/100ML (EQ 25MG BASE/ML)

INJECTABLE;INJECTION - EQ 2.5MG BASE/ML

INJECTABLE;INJECTION - EQ 20MG BASE/VIAL

INJECTABLE;INJECTION - EQ 20MG BASE/2ML (EQ 10MG BASE/ML)

INJECTABLE;INJECTION - EQ 25MG BASE/ML

INJECTABLE;INJECTION - EQ 500MG BASE/20ML (EQ 25MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - EQ 50MG BASE/VIAL

INJECTABLE;INJECTION - EQ 50MG BASE/2ML (EQ 25MG BASE/ML)

SOLUTION;SUBCUTANEOUS - 10MG/0.4ML (10MG/0.4ML)

SOLUTION;SUBCUTANEOUS - 12.5MG/0.5ML (12.5MG/0.5ML)

SOLUTION;SUBCUTANEOUS - 15MG/0.6ML (15MG/0.6ML)

SOLUTION;SUBCUTANEOUS - 17.5MG/0.7ML (17.5MG/0.7ML)

SOLUTION;SUBCUTANEOUS - 20MG/0.8ML (20MG/0.8ML)

SOLUTION;SUBCUTANEOUS - 22.5MG/ML (22.5MG/ML)

SOLUTION;SUBCUTANEOUS - 25MG/1ML (25MG/1ML)

SOLUTION;SUBCUTANEOUS - 7.5MG/0.3ML (7.5MG/0.3ML)

TABLET;ORAL - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc

4 SPI Pharma

2 Seqens

3 DKSH

1 Pharm-RX Chemical

5 Faran Shimi Pharmaceutical

12 Gangwal Healthcare

5 Nanjing Well Pharmaceutical

1 ACG Worldwide

9 Actylis

1 Aeon Procare

6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

17 BASF

1 Bioplus Life Sciences

1 Clariant

10 Corel Pharma Chem

6 DFE Pharma

3 Finar

9 Gangwal Chemicals

5 Ideal Cures Pvt Ltd

3 Ingredion Pharma Solutions

36 Kerry

3 Kima Chemical

6 Lonza Capsugel

11 Microlex e.U

1 Nanjing Bold Chemical

2 Nomisma Healthcare

1 Novo Excipients

2 Pharmatrans-Sanaq

5 Pluviaendo

INJECTABLE;INJECTION - EQ 500MG BASE/20ML (EQ 25MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons