Tromethamine | Pharma Excipients | News | Suppliers

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CHEMISTRY

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INACTIVE PHARMA INGREDIENTS

7 Suppliers, 6 USDMF, 1 NDC API, 2 Listed Suppliers

7 Suppliers
6 USDMF
1 NDC API
2 Listed Suppliers

FINISHED DOSAGE FORMULATIONS

37 FDF Dossiers Suppliers

37 FDF Dossiers Suppliers

EXCIPIENTS BY APPLICATIONS

2 Parenteral, 1 Topical

2 Parenteral
1 Topical

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 1 NEWS #PharmaBuzz

2 DATA COMPILATION #PharmaFlow
1 NEWS #PharmaBuzz

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2 EXCIPIENTS

2 EXCIPIENTS

REF. STANDARDS & IMPURITIES

1 Others

1 Others

Chemistry

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SUPPLIERS

01

Pfanstiehl

U.S.A

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

AACR Annual meeting

Not Confirmed

Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

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U.S.A

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USDMF

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

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Product Web Link

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Website

Corporate PDF

02

Suzhou Yacoo Science

China

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

AACR Annual meeting

Not Confirmed

03

Hubei Gedian Humanwell Pharmaceuti...

China

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

AACR Annual meeting

Not Confirmed

04

AVT (Shanghai)

China

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

AACR Annual meeting

Not Confirmed

05

AVT (Shanghai)

China

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

AACR Annual meeting

Not Confirmed

06

BioSpectra

U.S.A

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

AACR Annual meeting

Not Confirmed

07

CordenPharma

Germany

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

AACR Annual meeting

Not Confirmed

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USDMF

01

Pfanstiehl Inc

U.S.A

AACR Annual meeting

Not Confirmed

Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

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U.S.A

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TRIS BASE, HIGH PURITY, LOW ENDOTOXIN,...

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 39484

Submission : 2024-01-31

Status : Active

Type : IV

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

02

Avt (shanghai) Pharmaceutical Tech C...

China

AACR Annual meeting

Not Confirmed

03

Avt (shanghai) Pharmaceutical Tech C...

China

AACR Annual meeting

Not Confirmed

04

05

Hubei Gedian Humanwell Pharmaceutica...

China

AACR Annual meeting

Not Confirmed

06

Suzhou Yacoo Science Co Ltd

China

AACR Annual meeting

Not Confirmed

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NDC API

01

Corden Pharma Boulder, Inc.

Germany

AACR Annual meeting

Not Confirmed

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FINISHED DOSAGE FORMULATIONS

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FDF DOSSIERS SUPPLIERS

01

DR REDDYS

India

CPhI North America

Attending

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

BORTEZOMIB

Drug : BORTEZOMIB

Dosage Form : POWDER; INTRAVENOUS

Application Number : 206927

Country : US

Patented : No

Product Web Link

02

STRIDES PHARMA

India

euroPLX 88 Lisbon

Attending

Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

URSODIOL

Drug : URSODIOL

Dosage Form : TABLET; ORAL

Application Number : 213504

Country : US

Patented : No

Product Web Link

03

ACTAVIS MID ATLANTIC

CLINDAMYCIN PHOSPHATE; TRETINOIN

AACR Annual meeting

Not Confirmed

04

ALMIRALL

CLINDAMYCIN PHOSPHATE; TRETINOIN

AACR Annual meeting

Not Confirmed

05

AM REGENT

FOSPHENYTOIN SODIUM

AACR Annual meeting

Not Confirmed

06

BAUSCH AND LOMB INC

TIMOLOL MALEATE

AACR Annual meeting

Not Confirmed

07

BRACCO

IOPAMIDOL

AACR Annual meeting

Not Confirmed

08

BRACCO

IOPAMIDOL

AACR Annual meeting

Not Confirmed

09

BRACCO

IOPAMIDOL

AACR Annual meeting

Not Confirmed

10

BRACCO

IOPAMIDOL

AACR Annual meeting

Not Confirmed

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EXCIPIENTS BY APPLICATIONS

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Parenteral

01

Pfanstiehl

U.S.A

AACR Annual meeting

Not Confirmed

Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

Dosage Form : Injectable / Parenteral

Grade : Parenteral

Category : Parenteral

Brand Name : Tris Base

Application : Parenteral

Excipient Details : Tris (hydroxymethyl) aminomethane is used in electrophoresis, protein purification, enzyme assay, and as a buffering agent in biologics production.

Pharmacopoeia Ref : USP, EP, BP, ChP

Technical Specs : pH: 7 and 9

Ingredient(s) : Tris hydroxymethyl aminomethane

02

BioSpectra

U.S.A

AACR Annual meeting

Not Confirmed

Topical

01

BioSpectra

U.S.A

AACR Annual meeting

Not Confirmed

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.