Find Mannide Monooleate manufacturers, exporters & distributors on PharmaCompass

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Synopsis

ACTIVE PHARMA INGREDIENTS

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JDMF

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Chemistry

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Also known as: Dianhydro-d-mannitol monooleate, Arlacel a, Einecs 246-872-8, D-mannitol, dianhydro-, mono-9-octadecenoate, (z)-, Schembl3666282, Dtxsid0025525
Molecular Formula
C24H42O5
Molecular Weight
410.6  g/mol
InChI Key
JDRAOGVAQOVDEB-KTKRTIGZSA-N

Mannide Monooleate
1 2D Structure

Mannide Monooleate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(3-hydroxy-2,3,3a,5,6,6a-hexahydrofuro[3,2-b]furan-6-yl) (Z)-octadec-9-enoate
2.1.2 InChI
InChI=1S/C24H42O5/c1-2-3-4-5-6-7-8-9-10-11-12-13-14-15-16-17-22(26)29-21-19-28-23-20(25)18-27-24(21)23/h9-10,20-21,23-25H,2-8,11-19H2,1H3/b10-9-
2.1.3 InChI Key
JDRAOGVAQOVDEB-KTKRTIGZSA-N
2.1.4 Canonical SMILES
CCCCCCCCC=CCCCCCCCC(=O)OC1COC2C1OCC2O
2.1.5 Isomeric SMILES
CCCCCCCC/C=C\CCCCCCCC(=O)OC1COC2C1OCC2O
2.2 Synonyms
2.2.1 MeSH Synonyms

1. Arlacel A

2. Mannide Mono-oleate

3. Mannide Monooleate

4. Montanide Isa 720

2.2.2 Depositor-Supplied Synonyms

1. Dianhydro-d-mannitol Monooleate

2. Arlacel A

3. Einecs 246-872-8

4. D-mannitol, Dianhydro-, Mono-9-octadecenoate, (z)-

5. Schembl3666282

6. Dtxsid0025525

2.3 Create Date
2006-04-28
3 Chemical and Physical Properties
Molecular Weight 410.6 g/mol
Molecular Formula C24H42O5
XLogP36.4
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count5
Rotatable Bond Count17
Exact Mass410.30322444 g/mol
Monoisotopic Mass410.30322444 g/mol
Topological Polar Surface Area65 Ų
Heavy Atom Count29
Formal Charge0
Complexity464
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count4
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1

USDMF

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Seppic Sa

France

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Cophex
Not Confirmed

02

Seppic Sa

France

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Cophex
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03

Seppic Sa

France

USDMF

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Cophex
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04

Seppic Sa

France

USDMF

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Cophex
Not Confirmed
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DATA COMPILATION #PharmaFlow

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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.   

Impressions: 2427

https://www.pharmacompass.com/radio-compass-blog/excipient-market-overview-roquette-seqens-evonik-make-strategic-moves-new-guidelines-deal-with-contamination

#PharmaFlow by PHARMACOMPASS
12 Sep 2024

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Looking for 25339-93-9 / Mannide Monooleate API manufacturers, exporters & distributors?

Mannide Monooleate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Mannide Monooleate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Mannide Monooleate manufacturer or Mannide Monooleate supplier for your needs.

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PharmaCompass also assists you with knowing the Mannide Monooleate API Price utilized in the formulation of products. Mannide Monooleate API Price is not always fixed or binding as the Mannide Monooleate Price is obtained through a variety of data sources. The Mannide Monooleate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Mannide Monooleate

Synonyms

Dianhydro-d-mannitol monooleate, Arlacel a, Einecs 246-872-8, D-mannitol, dianhydro-, mono-9-octadecenoate, (z)-, Schembl3666282, Dtxsid0025525

Cas Number

25339-93-9

MONTANIDE ISA 206 Manufacturers

A MONTANIDE ISA 206 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of MONTANIDE ISA 206, including repackagers and relabelers. The FDA regulates MONTANIDE ISA 206 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. MONTANIDE ISA 206 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

MONTANIDE ISA 206 Suppliers

A MONTANIDE ISA 206 supplier is an individual or a company that provides MONTANIDE ISA 206 active pharmaceutical ingredient (API) or MONTANIDE ISA 206 finished formulations upon request. The MONTANIDE ISA 206 suppliers may include MONTANIDE ISA 206 API manufacturers, exporters, distributors and traders.

click here to find a list of MONTANIDE ISA 206 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

MONTANIDE ISA 206 USDMF

A MONTANIDE ISA 206 DMF (Drug Master File) is a document detailing the whole manufacturing process of MONTANIDE ISA 206 active pharmaceutical ingredient (API) in detail. Different forms of MONTANIDE ISA 206 DMFs exist exist since differing nations have different regulations, such as MONTANIDE ISA 206 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A MONTANIDE ISA 206 DMF submitted to regulatory agencies in the US is known as a USDMF. MONTANIDE ISA 206 USDMF includes data on MONTANIDE ISA 206's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The MONTANIDE ISA 206 USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of MONTANIDE ISA 206 suppliers with USDMF on PharmaCompass.

MONTANIDE ISA 206 GMP

MONTANIDE ISA 206 Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of MONTANIDE ISA 206 GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right MONTANIDE ISA 206 GMP manufacturer or MONTANIDE ISA 206 GMP API supplier for your needs.

MONTANIDE ISA 206 CoA

A MONTANIDE ISA 206 CoA (Certificate of Analysis) is a formal document that attests to MONTANIDE ISA 206's compliance with MONTANIDE ISA 206 specifications and serves as a tool for batch-level quality control.

MONTANIDE ISA 206 CoA mostly includes findings from lab analyses of a specific batch. For each MONTANIDE ISA 206 CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

MONTANIDE ISA 206 may be tested according to a variety of international standards, such as European Pharmacopoeia (MONTANIDE ISA 206 EP), MONTANIDE ISA 206 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (MONTANIDE ISA 206 USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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