Find Attapulgite manufacturers, exporters & distributors on PharmaCompass

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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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API Suppliers

API Suppliers

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USDMF

US DMFs Filed

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CEP/COS

CEP/COS Certifications

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JDMF

JDMFs Filed

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EU WC

EU WC

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KDMF

KDMF

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NDC API

NDC API

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VMF

NDC API

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Listed Suppliers

Other Suppliers

0INTERMEDIATES

REF. STANDARDS OR IMPURITIES

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EDQM

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USP

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JP

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Others

FINISHED DOSAGE FORMULATIONS

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FDA Orange Book

FDA (Orange Book)

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Canada

Canada

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Australia

Australia

0 DRUGS IN DEVELOPMENT

FDF Dossiers

DRUG PRODUCT COMPOSITIONS

0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

PATENTS & EXCLUSIVITIES

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US Patents

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US Exclusivities

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Health Canada Patents

API REF. PRICE (USD/KG)

GLOBAL SALES INFORMATION

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Chemistry

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Also known as: Q26840932
Molecular Formula
Al2H29Mg2O15Si4-
Molecular Weight
484.14  g/mol
InChI Key
DGMCGTFMFPEQLT-UHFFFAOYSA-M

Attapulgite
1 2D Structure

Attapulgite

2 Identification
2.1 Computed Descriptors
2.1.1 InChI
InChI=1S/2Al.2Mg.15H2O.4Si/h;;;;15*1H2;;;;/p-1
2.1.2 InChI Key
DGMCGTFMFPEQLT-UHFFFAOYSA-M
2.1.3 Canonical SMILES
O.O.O.O.O.O.O.O.O.O.O.O.O.O.[OH-].[Mg].[Mg].[Al].[Al].[Si].[Si].[Si].[Si]
2.2 Synonyms
2.2.1 Depositor-Supplied Synonyms

1. Q26840932

2.3 Create Date
2012-03-21
3 Chemical and Physical Properties
Molecular Weight 484.14 g/mol
Molecular Formula Al2H29Mg2O15Si4-
Hydrogen Bond Donor Count15
Hydrogen Bond Acceptor Count15
Rotatable Bond Count0
Exact Mass482.991512 g/mol
Monoisotopic Mass482.991512 g/mol
Topological Polar Surface Area15 Ų
Heavy Atom Count23
Formal Charge-1
Complexity0
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count23

FDF Dossiers

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01

Opus Pharmaceuticals

South Africa
EPS
Not Confirmed
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Opus Pharmaceuticals

South Africa
arrow
EPS
Not Confirmed

Activated attapulgite

Brand Name : Kantrexil Suspension

Dosage Form : SUS

Dosage Strength : 500mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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02

Opus Pharmaceuticals

South Africa
EPS
Not Confirmed
arrow

Opus Pharmaceuticals

South Africa
arrow
EPS
Not Confirmed

Activated attapulgite

Brand Name : Kantrexil Tablets

Dosage Form : TAB

Dosage Strength : 500mg

Packaging : 20X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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03

Opus Pharmaceuticals

South Africa
EPS
Not Confirmed
arrow

Opus Pharmaceuticals

South Africa
arrow
EPS
Not Confirmed

Activated attapulgite

Brand Name : Kantrexil Tablets

Dosage Form : TAB

Dosage Strength : 500mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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04

EPS
Not Confirmed
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EPS
Not Confirmed

Dimethicone; Nifuroxazide; ATTAPULGITE; oligogalacturonide

Brand Name :

Dosage Form : ORAL SUSPENSION

Dosage Strength : 50MG; 60MG; 25MG; 100MG

Packaging : 120 Ml/Bottle

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Turkey

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05

EPS
Not Confirmed
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EPS
Not Confirmed

Nifuroxazide; pectin; Dimethicone; Attapulgite

Brand Name : DIALIN

Dosage Form : ORAL SUSPENSION

Dosage Strength : 200MG; 60MG; 25MG; 100MG

Packaging : 120 ML/BOTTLE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Turkey

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Europe

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01

EPS
Not Confirmed
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arrow
EPS
Not Confirmed

Dimethicone; Nifuroxazide; ATTAPULGITE; oligogalacturonide

Brand Name :

Dosage Form : ORAL SUSPENSION

Dosage Strength : 50MG; 60MG; 25MG; 100MG

Packaging : 120 Ml/Bottle

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Turkey

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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: 2830

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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Attapulgite manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Attapulgite 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 Attapulgite manufacturer or Attapulgite supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Attapulgite manufacturer or Attapulgite supplier.

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

API | Excipient name

Attapulgite

Synonyms

Q26840932

Attagel 50 Manufacturers

A Attagel 50 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Attagel 50, including repackagers and relabelers. The FDA regulates Attagel 50 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Attagel 50 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

Attagel 50 Suppliers

A Attagel 50 supplier is an individual or a company that provides Attagel 50 active pharmaceutical ingredient (API) or Attagel 50 finished formulations upon request. The Attagel 50 suppliers may include Attagel 50 API manufacturers, exporters, distributors and traders.

Attagel 50 GMP

Attagel 50 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 Attagel 50 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 Attagel 50 GMP manufacturer or Attagel 50 GMP API supplier for your needs.

Attagel 50 CoA

A Attagel 50 CoA (Certificate of Analysis) is a formal document that attests to Attagel 50's compliance with Attagel 50 specifications and serves as a tool for batch-level quality control.

Attagel 50 CoA mostly includes findings from lab analyses of a specific batch. For each Attagel 50 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.

Attagel 50 may be tested according to a variety of international standards, such as European Pharmacopoeia (Attagel 50 EP), Attagel 50 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Attagel 50 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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