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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

7 API Suppliers, 1 USDMF, 1 NDC API, 6 Listed Suppliers, $ API Reference Price

7 API Suppliers
1 USDMF
1 NDC API
6 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

FINISHED DOSAGE FORMULATIONS

5 FDF Dossiers, 2 Europe, 3 Listed Dossiers

5 FDF Dossiers
2 Europe
3 Listed Dossiers

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow

media
1 DATA COMPILATION #PharmaFlow

MARKET PLACE

8 APIs, 1 FDF Dossiers

marketPlace
8 APIs
1 FDF Dossiers

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

Annual Reports (USD Million)

Finished Drug Prices

0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

Chemistry

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Click the button for full data set

Also known as: 3230-94-2, L-ornithine-l-aspartate, L-ornithine l-aspartate salt, Ornithine aspartate, (s)-2,5-diaminopentanoic acid compound with (s)-2-aminosuccinic acid (1:1), Ornithine aseparate

Molecular Formula

C₉H₁₉N₃O₆

Molecular Weight

265.26 g/mol

InChI Key

IXUZXIMQZIMPSQ-ZBRNBAAYSA-N

FDA UNII

JA08T3B97O

1 2D Structure

L-Ornithine L-aspartate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(2S)-2-aminobutanedioic acid;(2S)-2,5-diaminopentanoic acid

2.1.2 InChI

InChI=1S/C5H12N2O2.C4H7NO4/c6-3-1-2-4(7)5(8)9;5-2(4(8)9)1-3(6)7/h4H,1-3,6-7H2,(H,8,9);2H,1,5H2,(H,6,7)(H,8,9)/t4-;2-/m00/s1

2.1.3 InChI Key

IXUZXIMQZIMPSQ-ZBRNBAAYSA-N

2.1.4 Canonical SMILES

C(CC(C(=O)O)N)CN.C(C(C(=O)O)N)C(=O)O

2.1.5 Isomeric SMILES

C(C[C@@H](C(=O)O)N)CN.C([C@@H](C(=O)O)N)C(=O)O

2.2 Other Identifiers

2.2.1 UNII

JA08T3B97O

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Gepa-merz

2. L-ornithine-l-aspartate

3. Orn-asp

4. Ornithine Aspartate

5. Ornithylaspartate

2.3.2 Depositor-Supplied Synonyms

1. 3230-94-2

2. L-ornithine-l-aspartate

3. L-ornithine L-aspartate Salt

4. Ornithine Aspartate

5. (s)-2,5-diaminopentanoic Acid Compound With (s)-2-aminosuccinic Acid (1:1)

6. Ornithine Aseparate

7. L-aspartic Acid, Compd. With L-ornithine (1:1)

8. (2s)-2-aminobutanedioic Acid;(2s)-2,5-diaminopentanoic Acid

9. Ornithine Aspartate (l-ornithine L-aspartate)

10. Mfcd00058084

11. Hepa-merz (tn)

12. Lola

13. Ruigan

14. Schembl361185

15. Dtxsid30883964

16. Bcp13530

17. Hy-a0282

18. Ornithine Aspartate [who-dd]

19. L-ornithine L-aspartate Salt, Powder

20. Akos015998595

21. L-ornithine-l-aspartate (salt)

22. Ornithine L-form Aspartate [mi]

23. As-12577

24. L-ornithine, L-aspartate (1:1)

25. Aspartic Acid Compd. With Ornithine

26. Cs-0019764

27. O0440

28. Ornithine, L-, L-aspartate (1:1)

29. D08303

30. D70545

31. A821231

32. Q-102756

33. Q27281401

34. (s)-2,5-diaminopentanoic Acid (s)-2-aminosuccinic Acid Salt

35. (s)-2,5-diaminopentanoicacidcompoundwith(s)-2-aminosuccinicacid(1:1)

2.4 Create Date

2006-10-25

3 Chemical and Physical Properties

Molecular Formula	C₉H₁₉N₃O₆
Molecular Weight	265.26 g/mol
Hydrogen Bond Donor Count	6
Hydrogen Bond Acceptor Count	9
Rotatable Bond Count	7
Exact Mass	265.12738533 g/mol
Monoisotopic Mass	265.12738533 g/mol
Topological Polar Surface Area	190 Å²
Heavy Atom Count	18
Formal Charge	0
Complexity	228
Isotope Atom Count	0
Defined Atom Stereocenter Count	2
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

API SUPPLIERS

01

Evonik

Germany

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Adhesives & Bonding Expo

Attending

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Contact Supplier

Germany

Virtual Booth

Digital Content

USDMF

Click Us!

CEP/COS JDMF EU-WC NDC

KDMF VMF Others AUDIT

02

Summit Ingredients

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Medlab Asia & Asia Health

Not Confirmed

Not Confirmed

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

USDMF

01

Evonik Rexim Sas

Germany

IPPE

Attending

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Contact Supplier

Germany

Virtual Booth

Digital Content

L-ornithine L-aspartate

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 35044

Submission : 2020-08-19

Status : Active

Type : II

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

NDC API

01

Evonik Rexim S.A.S.

Germany

IPPE

Attending

Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

Contact Supplier

Germany

Virtual Booth

Digital Content

ORNITHINE ASPARTATE

NDC Package Code : 51593-5013

Start Marketing Date : 2021-06-28

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Listed Suppliers

01

02

03

04

05

06

Summit Ingredients

China

Antibody Engineering

Not Confirmed

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

API Reference Price

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PHARMA","supplierCountry":"FRANCE","foreign_port":"NA","customer":"MUNDIPHARMA","customerCountry":"INDIA","quantity":"349.00","actualQuantity":"349","unit":"KGS","unitRateFc":"76.3","totalValueFC":"30851.3","currency":"EUR","unitRateINR":"6626.1","date":"26-Feb-2022","totalValueINR":"2312517.63","totalValueInUsd":"30851.3","indian_port":"BOMBAY AIR","hs_no":"29225090","bill_no":"7656024","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"1400 MODI TOWER,98 NEHRU PLACE"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1645813800,"product":"L-ORNITHINE L-ASPARTATE MAKE: EVONIK REXIM","address":"1400 MODI TOWER,98 NEHRU PLACE","city":"NEW DELHI,DELHI","supplier":"MERZ PHARMA","supplierCountry":"FRANCE","foreign_port":"NA","customer":"MUNDIPHARMA","customerCountry":"INDIA","quantity":"482.00","actualQuantity":"482","unit":"KGS","unitRateFc":"76.3","totalValueFC":"42608.4","currency":"EUR","unitRateINR":"6626.1","date":"26-Feb-2022","totalValueINR":"3193792.25","totalValueInUsd":"42608.4","indian_port":"BOMBAY AIR","hs_no":"29225090","bill_no":"7656024","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"1400 MODI TOWER,98 NEHRU PLACE"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1650911400,"product":"TECHNICAL GRADE L-ORNITHINE L-ASPARTATE","address":"125 & 126 SIPCOT INDUSTRIAL COMPLE X,HOSUR, KRISHNAGIRI DIST, TAMILNAD","city":"HOSUR,TAMIL NADU","supplier":"ZHEJIANG UEASY BUSINESS ","supplierCountry":"CHINA","foreign_port":"NA","customer":"GLOBAL CALCIUM","customerCountry":"INDIA","quantity":"2000.00","actualQuantity":"2000","unit":"KGS","unitRateFc":"27.2","totalValueFC":"55626.5","currency":"USD","unitRateINR":"2098.5","date":"26-Apr-2022","totalValueINR":"4196960","totalValueInUsd":"55626.5","indian_port":"MADRAS SEA","hs_no":"29224990","bill_no":"8430642","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Technical Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"125 & 126 SIPCOT INDUSTRIAL COMPLE X,HOSUR, KRISHNAGIRI DIST, TAMILNAD"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1668537000,"product":"L-ORNITHINE L-ASPARTATE GMP","address":"KRISLON HOUSE SAKI VIHAR ROAD SAKI NAKA ANDHERI 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INT\\'L","customer":"MUNDIPHARMA","customerCountry":"INDIA","quantity":"775.00","actualQuantity":"775","unit":"KGS","unitRateFc":"84","totalValueFC":"72049.5","currency":"EUR","unitRateINR":"7719.6","date":"18-Mar-2024","totalValueINR":"5982690","totalValueInUsd":"72049.5","indian_port":"Bombay Air","hs_no":"29225090","bill_no":"2619404","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"ECKENHEIMER LANDSTRABE 100 60318 FRANKFURT AM MAIN Frankfurt am Main,, GERMANY GERMANY","customerAddress":"1400-HEMKUNT TOWER"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1710700200,"product":"L-ORNITHINE L-ASPARTATE MAKE: EVONIK REXIM BATCH NO. 6791231180","address":"1400-HEMKUNT TOWER","city":"NEW DELHI","supplier":"MERZ THERAPEUTICS GMBH","supplierCountry":"FRANCE","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"MUNDIPHARMA","customerCountry":"INDIA","quantity":"1057.50","actualQuantity":"1057.5","unit":"KGS","unitRateFc":"84","totalValueFC":"98312.8","currency":"EUR","unitRateINR":"7719.6","date":"18-Mar-2024","totalValueINR":"8163477","totalValueInUsd":"98312.8","indian_port":"Bombay Air","hs_no":"29225090","bill_no":"2619404","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"ECKENHEIMER LANDSTRABE 100 60318 FRANKFURT AM MAIN Frankfurt am Main,, GERMANY GERMANY","customerAddress":"1400-HEMKUNT TOWER"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1715711400,"product":"L-ORNITHINE L-ASPARTATE MAKE: EVONIK REXIM BATCH NO. 6791231166","address":"1400-HEMKUNT TOWER","city":"NEW DELHI","supplier":"MERZ THERAPEUTICS GMBH","supplierCountry":"FRANCE","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"MUNDIPHARMA","customerCountry":"INDIA","quantity":"1012.68","actualQuantity":"1012.68","unit":"KGS","unitRateFc":"84","totalValueFC":"92867.9","currency":"EUR","unitRateINR":"7644","date":"15-May-2024","totalValueINR":"7740925.92","totalValueInUsd":"92867.9","indian_port":"Bombay Air","hs_no":"29225090","bill_no":"3493428","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"ECKENHEIMER LANDSTRABE 100 60318 FRANKFURT AM MAIN Frankfurt am Main,, GERMANY GERMANY","customerAddress":"1400-HEMKUNT TOWER"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722364200,"product":"L-ORNITHINE L-ASPARTATE MAKE: EVONIK REXIM BATCH NO. 6791240271","address":"1400-HEMKUNT TOWER","city":"NEW DELHI","supplier":"MERZ THERAPEUTICS GMBH","supplierCountry":"FRANCE","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"MUNDIPHARMA","customerCountry":"INDIA","quantity":"1007.30","actualQuantity":"1007.3","unit":"KGS","unitRateFc":"101.2","totalValueFC":"113047","currency":"EUR","unitRateINR":"9381.2","date":"31-Jul-2024","totalValueINR":"9449723.05","totalValueInUsd":"113047","indian_port":"Bombay Air","hs_no":"29225090","bill_no":"4795214","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"ECKENHEIMER LANDSTRABE 100 60318 FRANKFURT AM MAIN Frankfurt am Main,, GERMANY GERMANY","customerAddress":"1400-HEMKUNT TOWER"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724351400,"product":"L-ORNITHINE L-ASPARTATE MAKE: EVONIK REXIM BATCH NO. 6791240354","address":"1400-HEMKUNT TOWER","city":"NEW DELHI","supplier":"MERZ THERAPEUTICS GMBH","supplierCountry":"FRANCE","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"MUNDIPHARMA","customerCountry":"INDIA","quantity":"1050.00","actualQuantity":"1050","unit":"KGS","unitRateFc":"101.2","totalValueFC":"118892.2","currency":"EUR","unitRateINR":"9497.6","date":"23-Aug-2024","totalValueINR":"9972501","totalValueInUsd":"118892.2","indian_port":"Bombay Air","hs_no":"29225090","bill_no":"5209485","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"ECKENHEIMER LANDSTRABE 100 60318 FRANKFURT AM MAIN Frankfurt am Main,, GERMANY GERMANY","customerAddress":"1400-HEMKUNT TOWER"}]

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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Drugs in Development

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

FDF Dossiers

01

Octavius Pharma Pvt. Ltd

India

MAGHREB PHARMA

Stand #B09

Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

Contact Supplier

India

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : India

L-Ornithine L-aspartate

Brand Name :

Dosage Form : Oral Powder

Dosage Strength : 3G

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

02

Brooks laboratories Limited

India

CPHI Middle east

Not Confirmed

03

Farmak JSC

Ukraine

CPHI Middle east

Not Confirmed

04

Farmak JSC

Ukraine

CPHI Middle east

Not Confirmed

05

Polifarma

Turkey

CPHI Middle east

Not Confirmed

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Europe

01

Farmak JSC

Ukraine

CPHI Middle east

Not Confirmed

02

Farmak JSC

Ukraine

CPHI Middle east

Not Confirmed

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Listed Dossiers

01

Octavius Pharma Pvt. Ltd

India

MAGHREB PHARMA

Stand #B09

Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

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L-Ornithine L-aspartate

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Brooks laboratories Limited

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Polifarma

Turkey

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Excipient Market Overview: Roquette, Seqens, Evonik make strategic moves; new guidelines deal with contamination

The pharmaceutical industry has long recognized the critical role excipients or inactive ingredients play in drug formulation and delivery. Excipients can comprise up to 90 percent of a medicine's total ingredients and serve crucial functions as binders, disintegrants, coatings, preservatives, colors, and flavorings. According to recent market research, the pharmaceutical excipients market was valued at US$ 9.27 billion in 2023. It is growing at a compound annual growth rate (CAGR) of 7.03 percent and is projected to reach US$ 18.48 billion by 2032. The main factors driving market growth is an increased demand for multifunctional excipients, coupled with the expanding use of generic medications. The development in the biologics sector and advancements in nanotechnology are also contributing significantly to market growth. Major excipient providers include BASF, Evonik, Merck KGaA owned MilliporeSigma, Gangwal Healthcare, Roquette Frères, DuPont, Croda International, Seqens, Boai NKY Pharmaceuticals, PMC Isochem, Minakem, Kewpie Corporation, Ashland Global, SPI Pharma, Pfanstiehl, Nanjing Well Pharmaceutical, ICE Pharma, Anhui Ribobay Pharmaceutical and Nippon Fine Chemical. View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available) WHO, India’s CDSCO tighten regulations; new GMP guidelines implemented to curb contamination Last year, the World Health Organization (WHO) issued a health alert linking at least 300 child deaths in the Gambia, Uzbekistan, and Indonesia to the ingestion of contaminated cough syrups containing unacceptable levels of diethylene glycol (DEG) and ethylene glycol (EG). In response to the tragic events, the WHO released two draft appendices to its guideline on good manufacturing practices (GMPs) for excipients this year. Manufacturers are now required to use suitable risk assessment tools to identify and mitigate potential hazards. Since India-made cough syrups had been linked to the deaths, India’s drug regulator — Central Drugs Standard Control Organization (CDSCO) — took steps to prevent contamination, and advised drugmakers to only use pharmaceutical-grade excipients from approved sources. Furthermore, the Indian Health Ministry proposed amendments to the Drugs and Cosmetics Rules, 1945 to include details of excipients on drug labels. While listing all excipients on every strip of medicine may be challenging, the ministry suggested mentioning those causing hypersensitivity on the label. Applicants now mandatorily need to submit evidence of stability and safety of excipients. These regulatory developments have significant implications for excipient manufacturers and pharmaceutical companies worldwide. Leading pharmaceutical excipient firms like Gangwal Healthcare, Sigachi Industries, and Nitika Pharmaceuticals are well-positioned to meet these heightened quality and safety standards, given their long-standing commitment to producing high-quality, compliant excipients. View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available) Roquette buys IFF’s pharma unit for US$ 2.85 bn; Evonik opens new spray-drying facility in Darmstadt In a significant industry move, France-based Roquette entered into an agreement to acquire IFF's pharma solutions business in a deal valued at US$ 2.85 billion. This acquisition is set to rebalance family-owned Roquette’s portfolio around health and nutrition. The deal is expected to accelerate Roquette’s growth and significantly strengthen its presence in the excipients market. Evonik has opened a new facility for drying aqueous dispersions of its Eudragit polymers at its site in Darmstadt, Germany. The facility will help Evonik meet increasing demand from drugmakers for its oral drug delivery solutions. The plant uses green energy solutions. The company has also partnered University of Mainz to commercialize a new class of polyethylene glycols (PEG) lipids for nucleic acid delivery. Evonik’s Health Care business has been growing its nucleic acid drug and vaccine delivery portfolio. Germany’s Johannes Gutenberg University of Mainz was the first to develop randomized polyethylene glycols (rPEGs). This collaboration aims to expand Evonik’s toolbox of technologies for nucleic acid-based medicines, offering an improved immunogenicity profile for lipid nanoparticle carriers used in mRNA vaccines and therapeutics. Asahi Kasei made significant strides in addressing a pressing industry concern that emerged in 2018 when potentially carcinogenic nitrosamine impurities were detected in several pharmaceuticals. Guided by regional authorities, such as the European Medicines Agency and the US Food and Drug Administration, the pharmaceutical industry has been carrying out extensive assessments and research to identify the cause of these impurities. In response to this challenge, Asahi Kasei developed its Ceolus microcrystalline cellulose with extremely low nitrite levels. The Japanese company achieved nitrite concentrations of 0.1 micrograms per gram or less, which is equivalent to 0.1 parts per million (ppm). The company also started full commercial operation of its second manufacturing facility for Ceolus in Japan, enhancing supply capacity and stability. JRS Pharma and Gujarat Microwax opened a state-of-the-art cotton-based croscarmellose sodium plant in Mehsana, Gujarat (India). This facility aims to produce high-quality excipients that meet global standards, potentially reducing India's dependency on imports and boosting its presence in the global excipient market. The Indian excipient industry accounts for less than 1 percent of the global market share. View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available) Seqens to advance innovative polymer; biologics, personalized medicine create demand for specialized excipients Recent industry collaborations highlight the ongoing innovation in novel excipients. France’s Seqens, with over 20 years of polymer development experience, was chosen by Pleryon Therapeutics to advance its leading osteoarthritis candidate – an innovative GMP polymer. This collaboration leverages Seqens’ newly expanded and modernized cGMP plant in Aramon, France, demonstrating the industry’s commitment to investing in advanced manufacturing capabilities for novel excipients. The rise of biologics and personalized medicine has created a demand for specialized excipients capable of stabilizing complex molecules and enabling targeted drug delivery. Roquette’s launch of Lycagel Flex, a hydroxypropyl pemix for nutraceutical and pharmaceutical softgel capsules, exemplifies this trend. Built on Roquette’s market-first Lycagel pea starch technology, this plant-based alternative to gelatin offers manufacturers the flexibility to customize formulations for a range of production and end-user needs. The innovative pea starch foundation also underscores the industry’s move towards sustainable bio-based excipients. The trend towards patient-centric drug development has also influenced excipient innovation. Excipients that can improve palatability, ease of swallowing, or enable novel dosage forms (such as orally disintegrating tablets) are in high demand. For example, IFF brought a super disintegrant Ac-Di-Sol, that supports faster disintegration and drug dissolution in oral disintegrating tablets, improving patient experience. View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available) Our view The heightened regulatory scrutiny on excipients due to product contamination incidents has created a high risk perception and uncertainty around the regulatory acceptance of novel excipients. That said, novel excipients are central to the development of new drug modalities and therapies. Going forward, sustainability will also become an increasingly important factor in excipient selection and development. As the industry innovates towards biologics, personalized therapies, and patient-centric formulations, the role of high-quality, multifunctional excipients will only grow more vital in ensuring drug stability, bioavailability, and patient compliance. Companies that can navigate the complex regulatory landscape, invest in R&D, and offer high-quality, multifunctional excipients will be well-positioned to succeed in this evolving market.