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API SUPPLIERS
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
SPI Pharma has been solving formulation challenges using superior functional materials.
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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USDMF
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Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Mucaine Suspension
Dosage Form : SUS
Dosage Strength : 291mg/5ml
Packaging : 100X1mg/5ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Mucaine Suspension
Dosage Form : SUS
Dosage Strength : 291mg/5ml
Packaging : 200X1mg/5ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
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Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Magnesium Trisilicate; Aluminium Hydroxide
Brand Name : Magnesium Trisilicate;...
Dosage Form : DC Granules
Dosage Strength : 250MG; 200MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
EUROAPI
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Dosage Form : Tablet
Grade : Oral
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Dosage Form : Cream / Lotion / Ointment
Grade : Topical, Parenteral
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Rochem International Inc
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Dosage Form : Suspension
Grade : Oral
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Dosage Form : Tablet
Grade : Oral
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Dosage Form : Capsule
Grade : Topical, Oral
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Dosage Form : Tablet
Grade : Oral
Application : Taste Masking
Excipient Details : Mannitol is used as a filler, bulking agent and taste masking agent in ODT formulations such as tablets.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Dosage Form : Suspension
Grade : Oral
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Dosage Form : Tablet
Grade : Oral
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Dosage Form : Suspension
Grade : Oral
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Dosage Form : Cream / Lotion / Ointment
Grade : Topical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Taste Masking
Excipient Details : CM90 is a directly compressible, granulated calcium carbonate with maltodextrin used for swallow tablets due to its high density and compressibility.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 490- 500 µm; Tapped Density: 1.50
Ingredient(s) : Calcium Carbonate Excipient
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Taste Masking
Excipient Details : CS90 is a directly compressible calcium carbonate with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-175 µm, Tapped Density: 0.85
Ingredient(s) : Calcium Carbonate Excipient
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet
Grade : Oral
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Direct Compression
Excipient Details : DC SIM 100 is a directly compressible simethicone powder used for antacid and anti-gas tablets.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet
Grade : Oral
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Taste Masking
Excipient Details : MS90 is a directly compressible magnesium hydroxide with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-170 µm, Tapped Density: 0.80
Ingredient(s) : Magnesium Hydroxide Excipient
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharm-RX Chemical
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ABOUT THIS PAGE
24
PharmaCompass offers a list of Aluminium Hydroxide 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 Aluminium Hydroxide manufacturer or Aluminium Hydroxide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Aluminium Hydroxide manufacturer or Aluminium Hydroxide supplier.
PharmaCompass also assists you with knowing the Aluminium Hydroxide API Price utilized in the formulation of products. Aluminium Hydroxide API Price is not always fixed or binding as the Aluminium Hydroxide Price is obtained through a variety of data sources. The Aluminium Hydroxide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Algeldrato manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Algeldrato, including repackagers and relabelers. The FDA regulates Algeldrato manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Algeldrato API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Algeldrato manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Algeldrato supplier is an individual or a company that provides Algeldrato active pharmaceutical ingredient (API) or Algeldrato finished formulations upon request. The Algeldrato suppliers may include Algeldrato API manufacturers, exporters, distributors and traders.
click here to find a list of Algeldrato suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Algeldrato DMF (Drug Master File) is a document detailing the whole manufacturing process of Algeldrato active pharmaceutical ingredient (API) in detail. Different forms of Algeldrato DMFs exist exist since differing nations have different regulations, such as Algeldrato USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Algeldrato DMF submitted to regulatory agencies in the US is known as a USDMF. Algeldrato USDMF includes data on Algeldrato's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Algeldrato USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Algeldrato suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Algeldrato Drug Master File in Japan (Algeldrato JDMF) empowers Algeldrato API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Algeldrato JDMF during the approval evaluation for pharmaceutical products. At the time of Algeldrato JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Algeldrato suppliers with JDMF on PharmaCompass.
A Algeldrato written confirmation (Algeldrato WC) is an official document issued by a regulatory agency to a Algeldrato manufacturer, verifying that the manufacturing facility of a Algeldrato active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Algeldrato APIs or Algeldrato finished pharmaceutical products to another nation, regulatory agencies frequently require a Algeldrato WC (written confirmation) as part of the regulatory process.
click here to find a list of Algeldrato suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Algeldrato as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Algeldrato API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Algeldrato as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Algeldrato and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Algeldrato NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Algeldrato suppliers with NDC on PharmaCompass.
Algeldrato 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 Algeldrato 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 Algeldrato GMP manufacturer or Algeldrato GMP API supplier for your needs.
A Algeldrato CoA (Certificate of Analysis) is a formal document that attests to Algeldrato's compliance with Algeldrato specifications and serves as a tool for batch-level quality control.
Algeldrato CoA mostly includes findings from lab analyses of a specific batch. For each Algeldrato 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.
Algeldrato may be tested according to a variety of international standards, such as European Pharmacopoeia (Algeldrato EP), Algeldrato JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Algeldrato USP).
