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API SUPPLIERS
Axplora is your partner of choice for complex APIs.
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NDC
EU
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Jai Radhe Sales is your partner for all your sourcing needs.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
EU-WC
NDC
Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
EU-WC
NDC
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USDMF
Axplora is your partner of choice for complex APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2023-12-26
Pay. Date : 2023-09-26
DMF Number : 32900
Submission : 2023-09-21
Status :
Type : II
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2022-06-28
Pay. Date : 2022-05-10
DMF Number : 36603
Submission : 2022-06-01
Status :
Type : II
Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
GDUFA
DMF Review : Complete
Rev. Date : 2023-10-18
Pay. Date : 2023-08-28
DMF Number : 35095
Submission : 2020-08-17
Status :
Type : II
Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35482
Submission : 2020-12-22
Status :
Type : IV
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
Axplora is your partner of choice for complex APIs.
Methylthioninium Chloride Hydrate
Certificate Number : CEP 2023-129 - Rev 00
Status : Valid
Issue Date : 2024-09-27
Type : Chemical
Substance Number : 1132
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
Methylthioninium Chloride Hydrate Ph. Eur.
Date of Issue : 2022-05-18
Valid Till : 2025-05-28
Written Confirmation Number : WC-0019
Address of the Firm : Plot No: 115, Ramky Pharma City (India) Ltd. SEZ, Parawada Mandal, Visakhapatnam...
Date of Issue : 2022-05-18
Valid Till : 2025-05-28
Written Confirmation Number : WC-0019
Address of the Firm : Plot No: 115, Ramky Pharma City (India) Ltd. SEZ, Parawada Mandal, Visakhapatnam...
Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
Date of Issue : 2022-03-28
Valid Till : 2025-02-17
Written Confirmation Number : WC-0438n
Address of the Firm : F-261, 262, 263, Riico Ind. Area, Gudli, Udaipur (Rajasthan), India
Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
Date of Issue : 2022-03-28
Valid Till : 2025-02-17
Written Confirmation Number : WC-0438n
Address of the Firm : F-261, 262, 263, Riico Ind. Area, Gudli, Udaipur (Rajasthan), India
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
Axplora is your partner of choice for complex APIs.
About the Company : Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-qual...
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
About the Company : Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs ...
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
About the Company : Macsen is a USFDA registered, TGA GMP & WHO-GMP certified manufacturer and supplier of Active Pharmaceutical Ingredients (APIs), Biological Stains & Specialty Fine Chemicals. Our c...
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Rochem International Inc
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.
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
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 : Tablet
Grade : Oral
Application : Disintegrants & Superdisintegrants
Excipient Details : Mannogem 2080 exhibits excellent flow, disintegration and compression properties.
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
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 : 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]DKSH
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Oral
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Oral
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Tablet
Grade : Oral
Application : Emulsifying Agents
Excipient Details : HDK N20 Pharma is used as a pharmaceutical emulsifying agent in tablets, capsules, syrups, and solutions.
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Suspension
Grade : Oral, Topical
Application : Rheology Modifiers
Excipient Details : HPMC 60HD4000 is used as thickener and viscosity modifier in oral solid, liquid and topical dosage forms.
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Suspension
Grade : Oral
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Oral
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Oral
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Tablet
Grade : Oral
Brand Name : Titanium dioxide PRETIOX ...
Application : Coloring Agents
Excipient Details : Titanium dioxide Pretiox AV01FG is used as a coloring and coating agent in oral solid dosage forms such as capsules, tablets, granules, and pellets.
Pharmacopoeia Ref : Fami-QS, Kosher, Halal, OHSAS ...
Technical Specs : Ti 59.95% and O 40.05%
Ingredient(s) : Titanium Dioxide
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Tablet
Grade : Oral
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Dosage Form : Tablet
Grade : Oral
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Dosage Form : Tablet
Grade : Oral
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Boai NKY Pharmaceuticals Ltd
Boai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.
Dosage Form : Tablet
Grade : Oral (Pharma Grade)
Boai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.
Dosage Form : Tablet
Grade : Oral (Pharma Grade)
Boai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.
Dosage Form : Tablet
Grade : Oral (Pharma Grade)
Boai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.
Dosage Form : Tablet
Grade : Oral (Pharma Grade)
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Tablet
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : Microlose (Lactose Monohydrate & Microcrystalline Cellulose) is used as a diluent in oral dosage forms such as tablets.
Pharmacopoeia Ref : DMF, EXCiPAT, KOSHER, HALAL, W...
Technical Specs : Lactose Monohydrate – 40%, Microcrystalline cellulose – 60%
Ingredient(s) : Lactose Monohydrate
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Tablet
Grade : Oral
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Capsule
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : ProBlend (SMCC) is a co-processed excipient consists of microcrystalline cellulose & colloidal silicon dioxide, used as a diluent & binder in OSDs.
Pharmacopoeia Ref : USP-NF, DMF, EXCiPAT, KOSHER, ...
Technical Specs : NA
Ingredient(s) : Silicified Microcrystalline Cellulose
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Capsule
Grade : Oral
Application : Disintegrants & Superdisintegrants
Excipient Details : Sallyso (Croscarmellose Sodium) is a cross-linked polymer of carboxymethylcellulose sodium, used as a superdisintegrant in tablets and capsules.
Pharmacopoeia Ref : USP-NF, BP, IP, EP, DMF, EXCiP...
Technical Specs : Sallyso 0.5 to 3.0%
Ingredient(s) : Croscarmellose Sodium
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Capsule
Grade : Oral
Application : Disintegrants & Superdisintegrants
Excipient Details : Solvostar (Sodium Starch Glycolate) is used as a superdisintegrant in oral solid dosage forms such as tablets and capsules.
Pharmacopoeia Ref : USP-NF, BP, IP, EP, DMF, EXCiP...
Technical Specs : Solvostar 2% to 8%
Ingredient(s) : Sodium Starch Glycolate
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Tablet
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : Starlose P40 (Starch & Lactose Monohydrate) is used as a diluent in oral dosage forms such as tablets.
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PharmaCompass offers a list of Methylene Blue 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 Methylene Blue manufacturer or Methylene Blue supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Methylene Blue manufacturer or Methylene Blue supplier.
PharmaCompass also assists you with knowing the Methylene Blue API Price utilized in the formulation of products. Methylene Blue API Price is not always fixed or binding as the Methylene Blue Price is obtained through a variety of data sources. The Methylene Blue Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Methylene Blue manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Methylene Blue, including repackagers and relabelers. The FDA regulates Methylene Blue manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Methylene Blue 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 Methylene Blue manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Methylene Blue supplier is an individual or a company that provides Methylene Blue active pharmaceutical ingredient (API) or Methylene Blue finished formulations upon request. The Methylene Blue suppliers may include Methylene Blue API manufacturers, exporters, distributors and traders.
click here to find a list of Methylene Blue suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Methylene Blue DMF (Drug Master File) is a document detailing the whole manufacturing process of Methylene Blue active pharmaceutical ingredient (API) in detail. Different forms of Methylene Blue DMFs exist exist since differing nations have different regulations, such as Methylene Blue USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Methylene Blue DMF submitted to regulatory agencies in the US is known as a USDMF. Methylene Blue USDMF includes data on Methylene Blue's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Methylene Blue USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Methylene Blue suppliers with USDMF on PharmaCompass.
A Methylene Blue CEP of the European Pharmacopoeia monograph is often referred to as a Methylene Blue Certificate of Suitability (COS). The purpose of a Methylene Blue CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Methylene Blue EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Methylene Blue to their clients by showing that a Methylene Blue CEP has been issued for it. The manufacturer submits a Methylene Blue CEP (COS) as part of the market authorization procedure, and it takes on the role of a Methylene Blue CEP holder for the record. Additionally, the data presented in the Methylene Blue CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Methylene Blue DMF.
A Methylene Blue CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Methylene Blue 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 Methylene Blue suppliers with CEP (COS) on PharmaCompass.
A Methylene Blue written confirmation (Methylene Blue WC) is an official document issued by a regulatory agency to a Methylene Blue manufacturer, verifying that the manufacturing facility of a Methylene Blue active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Methylene Blue APIs or Methylene Blue finished pharmaceutical products to another nation, regulatory agencies frequently require a Methylene Blue WC (written confirmation) as part of the regulatory process.
click here to find a list of Methylene Blue 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 Methylene Blue as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Methylene Blue 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 Methylene Blue 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 Methylene Blue and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Methylene Blue NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Methylene Blue suppliers with NDC on PharmaCompass.
Methylene Blue 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 Methylene Blue 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 Methylene Blue GMP manufacturer or Methylene Blue GMP API supplier for your needs.
A Methylene Blue CoA (Certificate of Analysis) is a formal document that attests to Methylene Blue's compliance with Methylene Blue specifications and serves as a tool for batch-level quality control.
Methylene Blue CoA mostly includes findings from lab analyses of a specific batch. For each Methylene Blue 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.
Methylene Blue may be tested according to a variety of international standards, such as European Pharmacopoeia (Methylene Blue EP), Methylene Blue JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Methylene Blue USP).
