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SPI Pharma
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Coating Systems & Additives
Excipient Details : ACTILLETS™ are microcrystalline cellulose spheres used in advanced drug formulations as starter cores for drug layering and coating.
Pharmacopoeia Ref : NA
Technical Specs : Bulk density: 0.80
Ingredient(s) : Microcrystalline Cellulose
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
Application : Chewable & Orodispersible Aids
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, 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
Application : Chewable & Orodispersible Aids
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, Taped Density: 0.80
Ingredient(s) : Starch
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ABOUT THIS PAGE
A Levomefolate Calcium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Levomefolate Calcium, including repackagers and relabelers. The FDA regulates Levomefolate Calcium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Levomefolate Calcium 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 Levomefolate Calcium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Levomefolate Calcium supplier is an individual or a company that provides Levomefolate Calcium active pharmaceutical ingredient (API) or Levomefolate Calcium finished formulations upon request. The Levomefolate Calcium suppliers may include Levomefolate Calcium API manufacturers, exporters, distributors and traders.
click here to find a list of Levomefolate Calcium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Levomefolate Calcium DMF (Drug Master File) is a document detailing the whole manufacturing process of Levomefolate Calcium active pharmaceutical ingredient (API) in detail. Different forms of Levomefolate Calcium DMFs exist exist since differing nations have different regulations, such as Levomefolate Calcium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Levomefolate Calcium DMF submitted to regulatory agencies in the US is known as a USDMF. Levomefolate Calcium USDMF includes data on Levomefolate Calcium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Levomefolate Calcium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Levomefolate Calcium suppliers with USDMF on PharmaCompass.
A Levomefolate Calcium written confirmation (Levomefolate Calcium WC) is an official document issued by a regulatory agency to a Levomefolate Calcium manufacturer, verifying that the manufacturing facility of a Levomefolate Calcium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Levomefolate Calcium APIs or Levomefolate Calcium finished pharmaceutical products to another nation, regulatory agencies frequently require a Levomefolate Calcium WC (written confirmation) as part of the regulatory process.
click here to find a list of Levomefolate Calcium 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 Levomefolate Calcium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Levomefolate Calcium 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 Levomefolate Calcium 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 Levomefolate Calcium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Levomefolate Calcium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Levomefolate Calcium suppliers with NDC on PharmaCompass.
Levomefolate Calcium 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 Levomefolate Calcium 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 Levomefolate Calcium GMP manufacturer or Levomefolate Calcium GMP API supplier for your needs.
A Levomefolate Calcium CoA (Certificate of Analysis) is a formal document that attests to Levomefolate Calcium's compliance with Levomefolate Calcium specifications and serves as a tool for batch-level quality control.
Levomefolate Calcium CoA mostly includes findings from lab analyses of a specific batch. For each Levomefolate Calcium 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.
Levomefolate Calcium may be tested according to a variety of international standards, such as European Pharmacopoeia (Levomefolate Calcium EP), Levomefolate Calcium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Levomefolate Calcium USP).
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