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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
GDUFA
DMF Review : Complete
Rev. Date : 2023-07-17
Pay. Date : 2023-07-13
DMF Number : 20448
Submission : 2007-04-10
Status :
Type : II
With Fermion, start the journey of your innovative API.
GDUFA
DMF Review : Complete
Rev. Date : 2020-12-30
Pay. Date : 2020-12-23
DMF Number : 9043
Submission : 1991-04-04
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
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API Imports and Exports
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Drugs in Development
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Regulatory Info :
Registration Country : Italy
Brand Name : Alprazolam
Dosage Form :
Dosage Strength : Gtt Os 20 Ml 0.75 Mg/Ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Sweden
Brand Name : Alprazolam Orion
Dosage Form : TABLET
Dosage Strength : 0.25 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Alprazolam Orion
Dosage Form : TABLET
Dosage Strength : 0.5 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Alprazolam Orion
Dosage Form : TABLET
Dosage Strength : 1 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Alprazolam Orion
Dosage Form : TABLET
Dosage Strength : 2 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
Regulatory Info : Generic
Registration Country : Canada
Brand Name :
Dosage Form : TABLET
Dosage Strength : 0.25MG
Packaging :
Approval Date :
Application Number : 74085
Regulatory Info : Generic
Registration Country : Canada
Regulatory Info : Generic
Registration Country : Canada
Brand Name :
Dosage Form : TABLET
Dosage Strength : 0.5MG
Packaging :
Approval Date :
Application Number : 78056
Regulatory Info : Generic
Registration Country : Canada
Regulatory Info : Generic
Registration Country : Canada
Brand Name :
Dosage Form : TABLET
Dosage Strength : 1MG
Packaging :
Approval Date :
Application Number : 74294
Regulatory Info : Generic
Registration Country : Canada
Regulatory Info : Generic
Registration Country : Canada
Brand Name :
Dosage Form : TABLET
Dosage Strength : 2MG
Packaging :
Approval Date :
Application Number : 74085
Regulatory Info : Generic
Registration Country : Canada
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - TABLET;ORAL - 0.25MG
USFDA APPLICATION NUMBER - 18276
DOSAGE - TABLET;ORAL - 0.5MG
USFDA APPLICATION NUMBER - 18276
DOSAGE - TABLET;ORAL - 1MG
USFDA APPLICATION NUMBER - 18276
DOSAGE - TABLET;ORAL - 2MG
USFDA APPLICATION NUMBER - 18276
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 0.5M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 0.5MG
USFDA APPLICATION NUMBER - 21434
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1MG
USFDA APPLICATION NUMBER - 21434
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 2MG
USFDA APPLICATION NUMBER - 21434
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 3MG
USFDA APPLICATION NUMBER - 21434
Related Excipient Companies
Evonik
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Rochem International Inc
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Alcedo Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Bioplus Life Sciences
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
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, Tablet
Grade : Parenteral, Oral
Application : Fillers, Diluents & Binders, Parenteral, Thickeners and Stabilizers
Excipient Details : D-mannitol protects proteins from denaturation & degradation. It is also used as a stabilizer in liquid formulations & as a bulking agent in tablets.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Dosage Form : Tablet
Grade : Oral
Application : Fillers, Diluents & Binders, 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 : Capsule, Orodispersible Tablet, Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids, Coating Systems & Additives, Fillers, Diluents & Binders
Excipient Details : Xylitol is used as filler, binder & a coating agent in various oral dosage forms in both pharmaceutical and nutraceutical applications.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking
Excipient Details : Pharmaburst® 500 is a directly compressible pharmaceutical excipient used to create orally disintegrating tablets quickly and easily.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Brand Name : Mannogem® XL Opal
Application : Direct Compression, Fillers, Diluents & Binders, Taste Masking
Excipient Details : Mannogem® XL Opal, directly compressible 160 µm spray-dried mannitol provides superior binding properties and tabletability.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Dosage Form : Tablet
Grade : Oral
Brand Name : Polyvinylpyrrolidone
Application : Fillers, Diluents & Binders
Excipient Details : Polyvinylpyrrolidone is used as a low viscosity wet binder in solid dosage forms such as tablets.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Dosage Form : Tablet
Grade : Oral
Application : Co-Processed Excipients
Excipient Details : Mannitol is a co-processed excipient with superior compactibility, lower disintegration time, and hygroscopicity.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Dosage Form : Tablet
Grade : Oral
Brand Name : Lactose Monohydrate
Application : Fillers, Diluents & Binders
Excipient Details : Lactose monohydrate is widely used as a filler and diluent in solid dosage forms such as tablets.
Boai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.
Application : Fillers, Diluents & Binders
Excipient Details : KoVidone® K25 is used as a low viscosity wet binder in solid dosage forms such as capsules and tablets.
Pharmacopoeia Ref : USP/NF, EP, JP, KP, IP, BP
Technical Specs : NA
Ingredient(s) : Polyvinylpyrrolidone
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Application : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders
Excipient Details : STARLOSE is used as a diluent, binder, directly compressible (DC), and co-processed excipient in tablets and capsules.
Coating Systems & Additives
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
Dosage Form : Capsule, Granule / Pellet, Tablet
Grade : Oral
Brand Name : EUDRAGIT® L 100-55
Application : Coating Systems & Additives, Controlled & Modified Release, Solubilizers
Excipient Details : EUDRAGIT® L 100-55 (powder) is used in delayed release coatings to enhance solubility of poorly soluble drugs such as tablets, capsules & granules.
Pharmacopoeia Ref : NA
Technical Specs : NA
Ingredient(s) : Methacrylic Acid - Ethyl Acrylate Copolymer
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Dosage Form : Capsule, Orodispersible Tablet, Tablet
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Excipient Details : Xylitol is used as filler, binder & a coating agent in various oral dosage forms in both pharmaceutical and nutraceutical applications.
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
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
Brand Name : EUDRAGIT® L 30 D-55
Application : Coating Systems & Additives, Film Formers & Plasticizers
Excipient Details : EUDRAGIT® L 30 D-55 (aqueous dispersion) is a delayed release polymer used as coating and film former in tablets, capsules, granules etc.
Pharmacopoeia Ref : NA
Technical Specs : NA
Ingredient(s) : Methacrylic Acid - Ethyl Acrylate Copolymer
Direct Compression
Disintegrants & Superdisintegrants
Controlled & Modified Release
Granulation
Taste Masking
Solubilizers
Thickeners and Stabilizers
Co-Processed Excipients
Chewable & Orodispersible Aids
Film Formers & Plasticizers
Lubricants & Glidants
Parenteral
Emulsifying Agents
Topical
API Stability Enhancers
Empty Capsules
Rheology Modifiers
Vegetarian Capsules
Surfactant & Foaming Agents
Coloring Agents
Soft Gelatin
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Niravam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Niravam, including repackagers and relabelers. The FDA regulates Niravam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Niravam 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 Niravam manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Niravam supplier is an individual or a company that provides Niravam active pharmaceutical ingredient (API) or Niravam finished formulations upon request. The Niravam suppliers may include Niravam API manufacturers, exporters, distributors and traders.
click here to find a list of Niravam suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Niravam DMF (Drug Master File) is a document detailing the whole manufacturing process of Niravam active pharmaceutical ingredient (API) in detail. Different forms of Niravam DMFs exist exist since differing nations have different regulations, such as Niravam USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Niravam DMF submitted to regulatory agencies in the US is known as a USDMF. Niravam USDMF includes data on Niravam's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Niravam USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Niravam 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 Niravam Drug Master File in Japan (Niravam JDMF) empowers Niravam 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 Niravam JDMF during the approval evaluation for pharmaceutical products. At the time of Niravam 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 Niravam suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Niravam Drug Master File in Korea (Niravam KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Niravam. The MFDS reviews the Niravam KDMF as part of the drug registration process and uses the information provided in the Niravam KDMF to evaluate the safety and efficacy of the drug.
After submitting a Niravam KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Niravam API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Niravam suppliers with KDMF on PharmaCompass.
A Niravam CEP of the European Pharmacopoeia monograph is often referred to as a Niravam Certificate of Suitability (COS). The purpose of a Niravam CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Niravam EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Niravam to their clients by showing that a Niravam CEP has been issued for it. The manufacturer submits a Niravam CEP (COS) as part of the market authorization procedure, and it takes on the role of a Niravam CEP holder for the record. Additionally, the data presented in the Niravam CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Niravam DMF.
A Niravam CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Niravam CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Niravam suppliers with CEP (COS) on PharmaCompass.
A Niravam written confirmation (Niravam WC) is an official document issued by a regulatory agency to a Niravam manufacturer, verifying that the manufacturing facility of a Niravam active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Niravam APIs or Niravam finished pharmaceutical products to another nation, regulatory agencies frequently require a Niravam WC (written confirmation) as part of the regulatory process.
click here to find a list of Niravam 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 Niravam as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Niravam 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 Niravam 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 Niravam and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Niravam NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Niravam suppliers with NDC on PharmaCompass.
Niravam 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 Niravam 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 Niravam GMP manufacturer or Niravam GMP API supplier for your needs.
A Niravam CoA (Certificate of Analysis) is a formal document that attests to Niravam's compliance with Niravam specifications and serves as a tool for batch-level quality control.
Niravam CoA mostly includes findings from lab analyses of a specific batch. For each Niravam 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.
Niravam may be tested according to a variety of international standards, such as European Pharmacopoeia (Niravam EP), Niravam JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Niravam USP).
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