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Ferric Carboxymaltose

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ACTIVE PHARMA INGREDIENTS

23 API Suppliers, 10 USDMF, 1 JDMF, 1 KDMF, 7 NDC API, 14 Listed Suppliers, $ API Reference Price

23 API Suppliers
10 USDMF
1 JDMF
1 KDMF
7 NDC API
14 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

12 Drugs in Development

12 Drugs in Development

FINISHED DOSAGE FORMULATIONS

19 FDF Dossiers, 4 FDA Orange Book, 2 Europe, 2 Australia, 1 South Africa, 10 Listed Dossiers

19 FDF Dossiers
4 FDA Orange Book
2 Europe
2 Australia
1 South Africa
10 Listed Dossiers

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 21 NEWS #PharmaBuzz

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3 DATA COMPILATION #PharmaFlow
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GLOBAL SALES INFORMATION

2 Finished Drug Prices, 7 Annual Reports

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2 Finished Drug Prices
7 Annual Reports

MARKET PLACE

24 APIs, 5 FDF Dossiers

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24 APIs
5 FDF Dossiers

PATENTS & EXCLUSIVITIES

95 US Patents, 8 US Exclusivities

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95 US Patents
8 US Exclusivities

Interquim Ferric Carboxymaltose

Synopsis

ACTIVE PHARMA INGREDIENTS

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0INTERMEDIATES

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Europe

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US Patents

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Health Canada Patents

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Chemistry

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Also known as: 9007-72-1, Ex-a3450, (2s,3s,4s,5r)-4-[(2r,3r,4r,5s,6r)-5-[(2r,3r,4r,5s,6r)-3,4-dihydroxy-6-(hydroxymethyl)-5-[(2r,3r,4s,5s,6r)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxan-2-yl]oxy-3,4-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-2,3,5,6-tetrahydroxyhexanoate;iron(3+);oxygen(2-);hydroxide;hydrate

Molecular Formula

C₂₄H₄₄FeO₂₅-

Molecular Weight

788.4 g/mol

InChI Key

MFBBZTDYOYZJGB-HAONTEFVSA-L

Ferric Carboxymaltose is an iron replacement product and chemically, an iron carbohydrate complex. FDA approved on July 25, 2013.

1 2D Structure

Ferric Carboxymaltose

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(2S,3S,4S,5R)-4-[(2R,3R,4R,5S,6R)-5-[(2R,3R,4R,5S,6R)-3,4-dihydroxy-6-(hydroxymethyl)-5-[(2R,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxan-2-yl]oxy-3,4-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-2,3,5,6-tetrahydroxyhexanoate;iron(3+);oxygen(2-);hydroxide;hydrate

2.1.2 InChI

InChI=1S/C24H42O22.Fe.2H2O.O/c25-1-5(29)18(11(32)14(35)21(39)40)44-23-16(37)12(33)20(7(3-27)42-23)46-24-17(38)13(34)19(8(4-28)43-24)45-22-15(36)10(31)9(30)6(2-26)41-22;;;;/h5-20,22-38H,1-4H2,(H,39,40);;2*1H2;/q;+3;;;-2/p-2/t5-,6-,7-,8-,9-,10+,11+,12-,13-,14+,15-,16-,17-,18+,19-,20-,22-,23-,24-;;;;/m1..../s1

2.1.3 InChI Key

MFBBZTDYOYZJGB-HAONTEFVSA-L

2.1.4 Canonical SMILES

C(C1C(C(C(C(O1)OC2C(OC(C(C2O)O)OC3C(OC(C(C3O)O)OC(C(CO)O)C(C(C(=O)[O-])O)O)CO)CO)O)O)O)O.O.[OH-].[O-2].[Fe+3]

2.1.5 Isomeric SMILES

C([C@@H]1[C@H]([C@@H]([C@H]([C@H](O1)O[C@@H]2[C@H](O[C@@H]([C@@H]([C@H]2O)O)O[C@@H]3[C@H](O[C@@H]([C@@H]([C@H]3O)O)O[C@@H]([C@@H](CO)O)[C@H]([C@@H](C(=O)[O-])O)O)CO)CO)O)O)O)O.O.[OH-].[O-2].[Fe+3]

2.2 Synonyms

2.2.1 MeSH Synonyms

1. Ferinject

2. Injectafer

3. Iron Carboxymaltose

4. Iron Dextri-maltose

5. Polynuclear Iron (iii)-hydroxide 4(r)-(poly-(1->4)-o-alpha-d-glucopyranosyl)-oxy-2(r),3(s),5(r), 6-tetrahydroxy-hexanoate

6. Vit 45

7. Vit-45

2.2.2 Depositor-Supplied Synonyms

1. 9007-72-1

2. Ex-a3450

3. (2s,3s,4s,5r)-4-[(2r,3r,4r,5s,6r)-5-[(2r,3r,4r,5s,6r)-3,4-dihydroxy-6-(hydroxymethyl)-5-[(2r,3r,4s,5s,6r)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxan-2-yl]oxy-3,4-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-2,3,5,6-tetrahydroxyhexanoate;iron(3+);oxygen(2-);hydroxide;hydrate

2.3 Create Date

2014-11-22

3 Chemical and Physical Properties

Molecular Formula	C₂₄H₄₄FeO₂₅-
Molecular Weight	788.4 g/mol
Hydrogen Bond Donor Count	16
Hydrogen Bond Acceptor Count	25
Rotatable Bond Count	13
Exact Mass	788.152102 g/mol
Monoisotopic Mass	788.152102 g/mol
Topological Polar Surface Area	382 Å²
Heavy Atom Count	50
Formal Charge	-1
Complexity	940
Isotope Atom Count	0
Defined Atom Stereocenter Count	19
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	5

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Injectafer
PubMed Health	ferric carboxymaltose
Drug Classes	Iron Supplement
Drug Label	Ferric carboxymaltose, an iron replacement product, is an iron carbohydrate complex with the chemical name of polynuclear iron (III) hydroxide 4(R)-(poly-(14)-O--D-glucopyranosyl)-oxy-2(R),3(S),5(R),6-tetrahydroxy-hexanoate. It has a relative mo...
Active Ingredient	Ferric carboxymaltose
Dosage Form	Injectable
Route	Intravenous
Strength	750mg iron/15ml (50mg iron/ml)
Market Status	Prescription
Company	Luitpold
Patent	7612109; 7754702

2 of 2
Drug Name	Injectafer
PubMed Health	ferric carboxymaltose
Drug Classes	Iron Supplement
Drug Label	Ferric carboxymaltose, an iron replacement product, is an iron carbohydrate complex with the chemical name of polynuclear iron (III) hydroxide 4(R)-(poly-(14)-O--D-glucopyranosyl)-oxy-2(R),3(S),5(R),6-tetrahydroxy-hexanoate. It has a relative mo...
Active Ingredient	Ferric carboxymaltose
Dosage Form	Injectable
Route	Intravenous
Strength	750mg iron/15ml (50mg iron/ml)
Market Status	Prescription
Company	Luitpold
Patent	7612109; 7754702

4.2 Drug Indication

Ferric carboxymaltose is a iron replacement product indicated for the treatment of iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron or those who have non-dialysis dependent chronic kidney disease.

FDA Label

5 Pharmacology and Biochemistry

5.1 Pharmacology

When measured using positron emission tomography (PET), the red cell uptake of 59-Fe and 52-Fe from INJECTAFER ranged from 61% to 99%. In patients with iron deficiency, the red cell uptake ranged from 91% to 99%. In patients with renal anemia, the red cell uptake ranged from 61% to 84%.

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Parenteral Iron Replacement [EPC]; Phosphate Binder [EPC]; Phosphate Chelating Activity [MoA]; Iron [CS]

5.3 Absorption, Distribution and Excretion

Absorption

When a single dose of 100 to 1000 mg of iron was given to iron deficient patients, the maximum serum concentration (Cmax) was 37 g/mL to 333 g/mL. These levels were obtained 15 minutes to 1.21 hours post dose (Tmax).

Route of Elimination

Renal elimination of iron was negligible.

Volume of Distribution

3 L

5.4 Biological Half-Life

7 to 12 hours.

5.5 Mechanism of Action

Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that release iron.

API SUPPLIERS

01

Interquim SA

Spain

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Medlab Asia & Asia Health

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Shanghai Minbiotech

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Rochem International Inc

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Sichuan Elixir Pharmaceuticals

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Viatris

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Interquim Sa

Spain

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Ferric Carboxymaltose

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 38006

Submission : 2024-07-17

Status : Active

Type : II

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Dr Reddys Laboratories Ltd

India

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DMF Review : Complete

Rev. Date : 2023-10-18

Pay. Date : 2023-07-06

DMF Number : 38204

Submission : 2023-03-29

Status : Active

Type : II

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Vifor (International) Inc.

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BrightGene Bio-Medical Technology C...

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Interquim SA

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About the Company : Interquim, founded in 1978, is now part of the Ferrer HealthTech division. Interquim specializes in the development of competitive processes for manufacturing high added-value APIs...

Interquim, founded in 1978, is now part of the Ferrer HealthTech division. Interquim specializes in the development of competitive processes for manufacturing high added-value APIs that meet stringent quality standards. Complying with European environmental and work safety regulations, Interquim’s products are exported to highly regulated pharmaceutical markets. Regulatory bodies and clients have approved its quality system and facilities. With state-of-the-art multi-production plants, drug synthesis, and quality-control labs, Interquim supports clients throughout the entire product lifecycle, from product development to marketing.

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Dr. Reddy's Laboratories

India

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Ferric Carboxymaltose

About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...

Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale

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Shanghai Minbiotech

China

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Ferric Carboxymaltose

About the Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological API...

Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square meters of R&D centers in Nantong, Jiangsu and Jinan, Shandong, with more than 13,000㎡ of production sites. While supplying products to customers, the company also provides services such as technology development, technology transfer and technology exchange, aiming to provide customers with comprehensive supply and solutions in the biomedical industry.

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About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.

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Rochem International Inc

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About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...

Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quality ingredients manufactured in China. Headquartered in the Hauppauge, New York, Rochem has 16 offices spread across the globe to cater to the needs of its customers. Rochem’s operations are fully cGMP compliant and has been audited by the USFDA as well as several multinational organizations. It also trains and audits its partners to ensure all of their technologies and systems are FDA-compliant.

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Sichuan Elixir Pharmaceuticals

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Ferric Carboxymaltose

About the Company : Specializing in natural & oncology APIs, we establish R&D and production platforms for new salt, crystal form & synthetic biology research. We cooperate with clients for IND, NDA, ...

Specializing in natural & oncology APIs, we establish R&D and production platforms for new salt, crystal form & synthetic biology research. We cooperate with clients for IND, NDA, ANDA, 505b(2) and P-IV challenges. Exploring macromolecular APIs, we focus on Glycans & polypeptides. Expertise in XDC drugs drives innovative research & payload production. With a global registration platform & international cGMP system, we offer API CMO/CDMO services worldwide. Our strategy combines FDF and APIs. Our labs meet GMP standards with a stable R&D team, over 10 years of experience, we've delivered 20+ successful projects.

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TAPI Technology & API Services

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About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...

Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, driving progress in the pharmaceutical industry. Leveraging our extensive experience and world-class expertise, we deliver one of the most comprehensive API portfolios in the industry. Additionally, we provide tailored CDMO services, harnessing our proficiency in diverse technologies to meet our partners' unique needs, ensuring flexibility and excellence in every project.

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Guangzhou Tosun Pharmaceutical

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Lee Pharma

India

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API Reference Price

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","customerCountry":"INDIA","quantity":"0.10","actualQuantity":"0.1","unit":"KGS","unitRateFc":"25000","totalValueFC":"2765.5","currency":"EUR","unitRateINR":"2323750","date":"18-Oct-2024","totalValueINR":"232375","totalValueInUsd":"2765.5","indian_port":"Ahmedabad Air","hs_no":"29400000","bill_no":"6185440","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"Joan Buscalla, 10 08173 Sant Cugat del Valles Barcelona - Spain SDNF SPAIN","customerAddress":"5th FLOOR, 5001-5002, PRERNA AARTIKA,"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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Antibody Engineering

Not Confirmed

07 CSL Vifor

Switzerland

Antibody Engineering

Not Confirmed

08 CSL Vifor

Switzerland

Antibody Engineering

Not Confirmed

09 Daiichi Sankyo

Japan

Antibody Engineering

Not Confirmed

10 CSL Vifor

Switzerland

Antibody Engineering

Not Confirmed

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FDF Dossiers

01

Dr. Reddy's Laboratories

India

Antibody Engineering

Not Confirmed

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Contact Supplier

India

Virtual Booth

Digital Content

Regulatory Info : Lead Market Dossiers- Under Development

Registration Country : India

Ferric Carboxymaltose

Brand Name :

Dosage Form : Injection

Dosage Strength : 50MG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info : Lead Market Dossiers- Under Development

Registration Country : India

02

Aspen Pharmacare Holdings

South Africa

Antibody Engineering

Not Confirmed

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South Africa

Virtual Booth

Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Ferric Carboxylatose

Brand Name : Ferinject

Dosage Form : INJ

Dosage Strength : 50mg/ml

Packaging : 10X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

03

Pharmathen SA

Greece

Antibody Engineering

Not Confirmed

Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Contact Supplier

Greece

Virtual Booth

Digital Content

Regulatory Info : USA

Registration Country : Greece

Ferric Carboxymaltose

Brand Name :

Dosage Form : Solution for Injection/Infusion

Dosage Strength : 100MG/2ML

Packaging :

Approval Date :

Application Number :

Regulatory Info : USA

Registration Country : Greece

Portfolio PDF

04

Pharmathen SA

Greece

Antibody Engineering

Not Confirmed

Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Contact Supplier

Greece

Virtual Booth

Digital Content

Regulatory Info : USA

Registration Country : Greece

Ferric Carboxymaltose

Brand Name :

Dosage Form : Solution for Injection/Infusion

Dosage Strength : 500MG/10ML

Packaging :

Approval Date :

Application Number :

Regulatory Info : USA

Registration Country : Greece

Portfolio PDF

05

Pharmathen SA

Greece

Antibody Engineering

Not Confirmed

Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Contact Supplier

Greece

Virtual Booth

Digital Content

Regulatory Info : USA

Registration Country : Greece

Ferric Carboxymaltose

Brand Name :

Dosage Form : Solution for Injection/Infusion

Dosage Strength : 750MG/15ML

Packaging :

Approval Date :

Application Number :

Regulatory Info : USA

Registration Country : Greece

Portfolio PDF

06

Pharmathen SA

Greece

Antibody Engineering

Not Confirmed

Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Contact Supplier

Greece

Virtual Booth

Digital Content

Regulatory Info : USA

Registration Country : Greece

Ferric Carboxymaltose

Brand Name :

Dosage Form : Solution for Injection/Infusion

Dosage Strength : 1000MG/20ML

Packaging :

Approval Date :

Application Number :

Regulatory Info : USA

Registration Country : Greece

Portfolio PDF

07

American Regent

U.S.A

Antibody Engineering

Not Confirmed

08

Biological E

India

Antibody Engineering

Not Confirmed

09

CSL Vifor

Switzerland

Antibody Engineering

Not Confirmed

10

Farbe Firma

India

Antibody Engineering

Not Confirmed

U.S.A

Antibody Engineering

Not Confirmed

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Europe

01

VIFOR FRANCE

Switzerland

Medlab Asia & Asia Health

Not Confirmed

02

VIFOR FRANCE

Switzerland

Pharmacare Limited, Woodmead

South Africa

Antibody Engineering

Not Confirmed

Contact Supplier

South Africa

Virtual Booth

Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Ferric Carboxylatose

Brand Name : Ferinject

Dosage Form : INJ

Dosage Strength : 50mg/ml

Packaging : 10X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

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Listed Dossiers

01

Dr. Reddy's Laboratories

India

Antibody Engineering

Not Confirmed

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Contact Supplier

India

Virtual Booth

Digital Content

Regulatory Info : Lead Market Dossiers- Under De...

Registration Country : India

Ferric Carboxymaltose

Brand Name :

Dosage Form : Injection

Dosage Strength : 50MG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info : Lead Market Dossiers- Under De...

Registration Country : India

02

Pharmathen SA

Greece

Antibody Engineering

Not Confirmed

Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Contact Supplier

Greece

Virtual Booth

Digital Content

Regulatory Info : USA

Registration Country : Greece

Ferric Carboxymaltose

Brand Name :

Dosage Form : Solution for Injection...

Dosage Strength : 100MG/2ML

Packaging :

Approval Date :

Application Number :

Regulatory Info : USA

Registration Country : Greece

Portfolio PDF

03

Pharmathen SA

Greece

Antibody Engineering

Not Confirmed

Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Contact Supplier

Greece

Virtual Booth

Digital Content

Regulatory Info : USA

Registration Country : Greece

Ferric Carboxymaltose

Brand Name :

Dosage Form : Solution for Injection...

Dosage Strength : 500MG/10ML

Packaging :

Approval Date :

Application Number :

Regulatory Info : USA

Registration Country : Greece

Portfolio PDF

04

Pharmathen SA

Greece

Antibody Engineering

Not Confirmed

Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Contact Supplier

Greece

Virtual Booth

Digital Content

Regulatory Info : USA

Registration Country : Greece

Ferric Carboxymaltose

Brand Name :

Dosage Form : Solution for Injection...

Dosage Strength : 750MG/15ML

Packaging :

Approval Date :

Application Number :

Regulatory Info : USA

Registration Country : Greece

Portfolio PDF

05

Pharmathen SA

Greece

Antibody Engineering

Not Confirmed

Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Contact Supplier

Greece

Virtual Booth

Digital Content

Regulatory Info : USA

Registration Country : Greece

Ferric Carboxymaltose

Brand Name :

Dosage Form : Solution for Injection...

Dosage Strength : 1000MG/20ML

Packaging :

Approval Date :

Application Number :

Regulatory Info : USA

Registration Country : Greece

Portfolio PDF

Product Web Link

Virtual Booth

India

Antibody Engineering

Not Confirmed

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Digital Content

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DATA COMPILATION #PharmaFlow

DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

Drug Master Files, or DMFs, are confidential documents that play a crucial role in the pharmaceutical industry. These files, submitted to the US Food and Drug Administration (FDA), contain detailed information about ingredients, manufacturing processes, and packaging of medicines. They help the FDA oversee drug quality. Of the four types, Type II DMFs involve active pharmaceutical ingredients (APIs) for both branded and generic drugs. The third quarter (Q3) of 2024 saw Type II DMF submissions set a new record. A total of 309 Type II DMFs were submitted to the FDA during this period, a substantial 24.6 percent increase over Q3 2023 (with 248 submissions). The second quarter of 2024 too saw a remarkable increase, with 237 Type II DMFs being submitted compared to 178 in Q2 2023. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) China witnesses steep rise in DMF submissions, beats India with maximum filings In Q3 2024, China filed 153 DMFs submissions, marking a substantial 57.7 percent increase from the 97 submissions filed in Q3 2023. India maintained its strong position but fell to the number two spot with 110 DMFs, representing a modest 3.8 percent increase from 106 in Q3 2023. The US, which came a distant third, saw a slight decline in DMF submissions, with 13 filed in Q3 2024, as compared to 18 in Q3 2023. For several years, India had a lead in Type II DMFs. Since 2020, which marked the start of the pandemic, we have noticed a gradual increase in DMFs filed by China. This year, China has surpassed India considerably in the first three quarters. During the first nine months of 2024, China submitted 372, while India filed 286 DMFs. If this lead is maintained in Q4, DMFs from China will surpass that of India in 2024. Amongst European countries, Spain led with seven DMFs, followed by Italy at four, and Germany and the Netherlands at three each. Among other nations, Japan contributed six while Israel submitted four DMFs. In company-wise tally, China’s Jiangsu East-Mab Biomedical Technology topped the list with an impressive 14 DMFs. On its heels were Indian companies — MSN at 13 DMFs, and Vamsi Labs and Hetero Drugs at nine DMFs each. China’s Porton Pharma and Wuxi AppTec filed five, while Shanghai Keze Yongxin Biotechnology, and Qingdao Glycogene Pharmaceutical contributed four submissions each. India's Maithri Drugs also submitted four. Japanese company Santeja filed five. Overall, Asia accounted for nearly 90 percent, with China contributing a dominant 49.5 percent of all DMF submissions. India was at 35.6 percent, the US at 4.2 percent, while Europe contributed 6.5 percent. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) Diabetes, obesity, cancer, women’s health drugs emerge as hot molecules in Q3 2024 In terms of molecules, semaglutide (used for the treatment of type 2 diabetes and weight management) and relugolix (to treat prostate cancer and uterine fibroids) saw six DMF filings each in Q3 2024, indicating significant industry interest in these compounds. Following closely behind were semaglutide’s competitor tirzepatide and overactive bladder therapy vibegron, garnering four DMFs each. Finerenone (a non-steroidal drug for chronic kidney disease associated with type 2 diabetes) and voclosporin (an immunosuppressant for lupus nephritis) saw three DMFs each. The last quarter also witnessed the introduction of 14 molecules with first-time DMFs. Among them were acetoxy empagliflozin, cabozantinib fumarate, tivozanib hydrochloride monohydrate, diosmetin, trilaciclib, clenbuterol hydrochloride, fenoterol hydrobromide, tapinarof and fezolinetant. Fezolinetant, with a DMF from Spain’s Moehs Iberica, is the active ingredient in Astellas’ Veozah, which is the first non-hormonal treatment for menopausal symptoms approved by the FDA. Tapinarof, filed by India’s Maithri Drugs, is used in Vtama, a novel steroid-free psoriasis cream. Other compounds that made their DMF debut include berotralstat, calcium phosphoryl choline chloride, phloroglucinol dihydrate, belumosudil mesylate and trimethylphloroglucinol. During Q2 2024, there were 19 drugs that saw DMF submissions for the first time, including molecules like triptorelin, sorafenib, pralsetinib, trilaciclib dihydrochloride, resmetirom (hepatology) and teneligliptin hydrochloride hydrate (metabolic disorders). View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) GDUFA fee for FY 2025: The FDA’s Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry. The fiscal year 2025 fee rates were published on July 31, 2024. The FDA has revised fees under GDUFA III for all categories. While there is a slight increase in the DMF fee from US$ 94,682 in 2024 to US$ 95,084 in 2025, the ANDA fee has witnessed a significant jump — from US$ 252,453 in 2024 to US$ 321,920 in 2025. FY 2024 and FY 2025 User Fee Rates Generic drug fee category Fees rates for FY 2024 Fees rates for FY 2025 Applications: Abbreviated New Drug Application (ANDA) US$ 2,52,453 US$ 3,21,920 Drug Master File (DMF) US$ 94,682 US$ 95,084 Facilities: Active Pharmaceutical Ingredient (API)—Domestic US$ 40,464 US$ 41,580 API—Foreign US$ 55,464 US$ 56,580 Finished Dosage Form (FDF)—Domestic US$ 2,20,427 US$ 2,31,952 FDF—Foreign US$ 2,35,427 US$ 2,46,952 Contract Manufacturing Organization (CMO)—Domestic US$ 52,902 US$ 55,668 CMO—Foreign US$ 67,902 US$ 70,668 GDUFA Program: Large size operation generic drug applicant US$ 17,29,629 US$ 18,91,664 Medium size operation generic drug applicant US$ 6,91,852 US$ 7,56,666 Small business generic drug applicant US$ 1,72,963 US$ 1,89,166 Our view The highlight of the last few quarters has been the sharp rise in Type II DMF filings from China. The submission of a DMF is not required by law or any FDA regulation. FDA’s DMF guideline offers guidance on acceptable approaches to meeting regulatory requirements. Moreover, DMFs establish trust in APIs from lesser-known companies. With a growing emphasis on compliance and quality assurance, it appears that Chinese drug companies are eager to demonstrate their commitment to high standards and build trust in the US market. And that’s good news for the pharmaceutical industry.