Polysorbate 80 | Pharma Excipients | News | Suppliers

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Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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INACTIVE PHARMA INGREDIENTS

6 Suppliers, 6 USDMF, 3 CEP/COS, 11 Listed Suppliers

6 Suppliers
6 USDMF
3 CEP/COS
11 Listed Suppliers

FINISHED DOSAGE FORMULATIONS

829 FDF Dossiers Suppliers, 120 FDA Listed Dossiers

829 FDF Dossiers Suppliers
120 FDA Listed Dossiers

EXCIPIENTS BY APPLICATIONS

10 Solubilizers, 5 Parenteral, 3 Emulsifying Agents, 3 Topical, 2 Surfactant & Foaming Agents, 2 Thickeners and Stabilizers, 2 Film Formers & Plasticizers, 1 API Stability Enhancers, 1 Co-Processed Excipients, 1 Direct Compression, 1 Rheology Modifiers

10 Solubilizers
5 Parenteral
3 Emulsifying Agents
3 Topical
2 Surfactant & Foaming Agents
2 Thickeners and Stabilizers
2 Film Formers & Plasticizers
1 API Stability Enhancers
1 Co-Processed Excipients
1 Direct Compression
1 Rheology Modifiers

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow

1 DATA COMPILATION #PharmaFlow

MARKET PLACE

14 EXCIPIENTS

14 EXCIPIENTS

REF. STANDARDS & IMPURITIES

1 Others

1 Others

Chemistry

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SUPPLIERS

01

Evonik

Germany

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

CPhI WW Frankfurt

Booth #6.1B44

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

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Germany

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USDMF

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CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

Product Web Link

02

Nanjing Well Pharmaceutical

China

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

CPhI China

Booth #E3D78A

Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

Contact Supplier

China

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Digital Content

USDMF

CEP/COS

JDMF EU-WC NDC KDMF VMF Others AUDIT

03

Seppic

France

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

IOPC

Not Confirmed

Not Confirmed

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USDMF

01

Evonik Rexim (nanning) Pharmaceutica...

Germany

CPhI WW Frankfurt

Booth #6.1B44

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

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Germany

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POLYSCORBATE 80

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 38918

Submission : 2023-10-03

Status : Active

Type : IV

Product Web Link

02

Nanjing Well Pharmaceutical Group Co...

China

CPhI China

Booth #E3D78A

Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

Contact Supplier

China

Virtual Booth

Digital Content

POLYSORBATE 80

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 35699

Submission : 2021-04-14

Status : Active

Type : IV

03

Kolb Distribution Ltd

Switzerland

Simposio AFI

Not Confirmed

04

Seppic Sa

France

Simposio AFI

Not Confirmed

05

Seppic Sa

France

Simposio AFI

Not Confirmed

06

Seppic Sa

France

Simposio AFI

Not Confirmed

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CEP/COS

01

NANJING WELL PHARMACEUTICAL GROUP C...

China

CPhI China

Booth #E3D78A

Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

Contact Supplier

China

Virtual Booth

Digital Content

Polysorbate 80

Certificate Number : R0-CEP 2020-419 - Rev 00

Status : Valid

Issue Date : 2022-04-01

Type : Chemical

Substance Number : 428

02

KOLB DISTRIBUTION LTD. Hedingen CH

Switzerland

Simposio AFI

Not Confirmed

03

SEPPIC S.A. Paris Cedex 07 FR

France

Simposio AFI

Not Confirmed

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

FINISHED DOSAGE FORMULATIONS

Upload your portfolio for free, ask us

FDF DOSSIERS SUPPLIERS

01

SANOFI AVENTIS US

France

BIO International Convention

Exhibiting

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

DOCETAXEL

Drug : TAXOTERE

Dosage Form : INJECTABLE; INJECTION

Application Number : 20449

Country : US

Patented : No

Portfolio PDF

Product Web Link

02

SANOFI AVENTIS US

France

BIO International Convention

Exhibiting

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

PRIMAQUINE PHOSPHATE

Drug : PRIMAQUINE

Dosage Form : TABLET; ORAL

Application Number : 8316

Country : US

Patented : No

Portfolio PDF

Product Web Link

03

ABLYNX NV

France

BIO International Convention

Exhibiting

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

CAPLACIZUMAB-YHDP

Drug : CABLIVI

Dosage Form : INJECTABLE; INJECTION

Application Number : 761112

Country : US

Patented : No

Portfolio PDF

Product Web Link

04

GENZYME

France

BIO International Convention

Exhibiting

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

ALGLUCOSIDASE ALFA

Drug : MYOZYME

Dosage Form : INJECTABLE; IV (INFUSION)

Application Number : 125141

Country : US

Patented : No

Portfolio PDF

Product Web Link

05

ABBVIE

U.S.A

IOPC

Not Confirmed

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LOPINAVIR; RITONAVIR

Drug : KALETRA

Dosage Form : TABLET; ORAL

Application Number : 21906

Country : US

Patented : No

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

06

ABBVIE

U.S.A

IOPC

Not Confirmed

PREDNISOLONE ACETATE

Drug : PRED FORTE

Dosage Form : SUSPENSION/DROPS; OPHTHALMIC

Application Number : 17011

Country : US

Patented : No

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

07

ABBVIE

U.S.A

IOPC

Not Confirmed

PREDNISOLONE ACETATE

Drug : PRED MILD

Dosage Form : SUSPENSION/DROPS; OPHTHALMIC

Application Number : 17100

Country : US

Patented : No

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

08

ABBVIE

U.S.A

IOPC

Not Confirmed

FLUOROMETHOLONE

Drug : FML

Dosage Form : SUSPENSION/DROPS; OPHTHALMIC

Application Number : 16851

Country : US

Patented : No

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

09

ABBVIE

U.S.A

IOPC

Not Confirmed

NEBIVOLOL HYDROCHLORIDE; VALSARTAN

Drug : BYVALSON

Dosage Form : TABLET; ORAL

Application Number : 206302

Country : US

Patented : Yes

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

10

ABBVIE ENDOCRINE

U.S.A

IOPC

Not Confirmed

LEUPROLIDE ACETATE; NORETHINDRONE ACETATE

Drug : LUPANETA PACK

Dosage Form : INJECTABLE, TABLET; INTRAMUSCULAR, ORAL

Application Number : 203696

Country : US

Patented : No

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

Only 10 entries up to this point, click to access all

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EXCIPIENTS BY APPLICATIONS

Click here to find the perfect excipient manufacturers by their capabilities

Solubilizers

01

Nanjing Well Pharmaceutical

China

CPhI China

Booth #E3D78A

Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

Dosage Form : Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Tablet

Grade : Parenteral, Oral, Topical

Category : Solubilizers

Brand Name : Polysorbate 80

Application : Solubilizers

Excipient Details : Polysorbate 80 is used as a plasticizer, solubilizer, emulsifier, surfactant, and suspension stabilizer. It is also used in parenteral products.

Pharmacopoeia Ref : ChP/USP/EP/JP

Technical Specs : NA

Ingredient(s) : Polysorbate 80

Excipients Web Link

France

IOPC

Not Confirmed

Only 10 entries up to this point, click to access all

Parenteral

01

Nanjing Well Pharmaceutical

China

CPhI China

Booth #E3D78A

Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

Dosage Form : Injectable / Parenteral

Grade : Parenteral, Oral, Topical

Category : Parenteral

Brand Name : Polysorbate 80

Application : Parenteral

Excipient Details : Polysorbate 80 is used as a plasticizer, solubilizer, emulsifier, surfactant, and suspension stabilizer. It is also used in parenteral products.

Pharmacopoeia Ref : ChP/USP/EP/JP

Technical Specs : NA

Ingredient(s) : Polysorbate 80

Excipients Web Link

Nanjing Well Pharmaceutical

China

CPhI China

Booth #E3D78A

Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

Dosage Form : Cream / Lotion / Ointment, Emulsion, Injectable / Parenteral

Grade : Parenteral, Oral, Topical

Category : Emulsifying Agents

Brand Name : Polysorbate 80

Application : Emulsifying Agents

Excipient Details : Polysorbate 80 is used as a plasticizer, solubilizer, emulsifier, surfactant, and suspension stabilizer. It is also used in parenteral products.

Pharmacopoeia Ref : ChP/USP/EP/JP

Technical Specs : NA

Ingredient(s) : Polysorbate 80

02

Gangwal Chemicals

India

IOPC

Not Confirmed

03

Gangwal Chemicals

India

IOPC

Not Confirmed

Topical

Surfactant Foaming Agents

Thickeners And Stabilizers

01

Nanjing Well Pharmaceutical

China

CPhI China

Booth #E3D78A

Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

Dosage Form : Suspension

Grade : Parenteral, Oral, Topical

Category : Thickeners and Stabilizers

Brand Name : Polysorbate 80

Application : Thickeners and Stabilizers

Excipient Details : Polysorbate 80 is used as a plasticizer, solubilizer, emulsifier, surfactant, and suspension stabilizer. It is also used in parenteral products.

Pharmacopoeia Ref : ChP/USP/EP/JP

Technical Specs : NA

Ingredient(s) : Polysorbate 80

02

Gangwal Chemicals

India

IOPC

Not Confirmed

Film Formers Plasticizers

API Stability Enhancers

Co Processed Excipients

Direct Compression

Rheology Modifiers

Digital Content

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DATA COMPILATION #PharmaFlow

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.