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- EQ 500MG BASE/20ML (EQ 25MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - EQ 50MG BASE/VIAL, INJECTABLE;INJECTION - EQ 50MG BASE/2ML (EQ 25MG BASE/ML),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(7.5MG/0.3ML), TABLET;ORAL - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 Jai Radhe Sales, 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 Lubricants & Glidants, 16 Co-Processed Excipients, 14 Parenteral, 12 Film Formers & Plasticizers, 11 Taste Masking, 8 Emulsifying Agents, 6 Chewable & Orodispersible Aids, 5 Empty Capsules, 5 API Stability Enhancers, 4 Coloring Agents, 4 Rheology Modifiers, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents

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USFDA APPLICATION NUMBER - 11719 / DOSAGE - INJECTABLE;INJECTION - EQ 1GM BASE/40ML (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	Accord Healthcare, Inc.	Hospira, Inc.	Mylan Institutional LLC	Pfizer Laboratories Div Pfizer Inc.	Sandoz Inc	Teva Parenteral Medicines, Inc.
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 Jai Radhe Sales

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

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