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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
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USDMF
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2024-04-12
Pay. Date : 2017-09-08
DMF Number : 32057
Submission : 2020-06-29
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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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
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API Imports and Exports
Drugs in Development
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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 - 10MG;100MG
USFDA APPLICATION NUMBER - 17555
DOSAGE - TABLET;ORAL - 25MG;100MG
USFDA APPLICATION NUMBER - 17555
DOSAGE - TABLET;ORAL - 25MG;250MG
USFDA APPLICATION NUMBER - 17555
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 25MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19856
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 50MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 50MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19856
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 23....DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 23.75MG;95MG
USFDA APPLICATION NUMBER - 203312
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 36....DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 36.25MG;145MG
USFDA APPLICATION NUMBER - 203312
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 48....DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 48.75MG;195MG
USFDA APPLICATION NUMBER - 203312
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 61....DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 61.25MG;245MG
USFDA APPLICATION NUMBER - 203312
DOSAGE - TABLET;ORAL - 12.5MG;200MG;50MG
USFDA APPLICATION NUMBER - 21485
DOSAGE - TABLET;ORAL - 18.75MG;200MG;75MG
USFDA APPLICATION NUMBER - 21485
DOSAGE - TABLET;ORAL - 25MG;200MG;100MG
USFDA APPLICATION NUMBER - 21485
DOSAGE - TABLET;ORAL - 31.25MG;200MG;125MG
USFDA APPLICATION NUMBER - 21485
DOSAGE - TABLET;ORAL - 37.5MG;200MG;150MG
USFDA APPLICATION NUMBER - 21485
DOSAGE - TABLET;ORAL - 50MG;200MG;200MG
USFDA APPLICATION NUMBER - 21485
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Coating Systems & Additives
Disintegrants & Superdisintegrants
Controlled & Modified Release
Direct Compression
Solubilizers
Thickeners and Stabilizers
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Taste Masking
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids, Taste Masking
Excipient Details : Aspartame is an artificial sweetener that is used as a orodispersible aid and taste masking agent in pharmaceutical formulations such as 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.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
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Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
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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
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
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Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
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Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
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Excipient Details : Sorbitol’s bulk sweetness and compatibility with active ingredients makes it an ideal taste masking agent in pharmaceutical formulations.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet, Tablet
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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, Tablet
Grade : Oral
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Excipient Details : Pharmaburst® 500 is a directly compressible, co-processed 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, Orodispersible Tablet
Grade : Oral
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Excipient Details : Advantol® 300 is a DC pharmaceutical excipient used to create soft chew or fast melt oral dosage forms through co-processing technology.
Film Formers & Plasticizers
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Rheology Modifiers
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API Stability Enhancers
Coloring Agents
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Granule / Pellet, Tablet
Grade : Oral
Brand Name : Red Ferric Oxide S
Application : Coloring Agents
Excipient Details : Red Ferric Oxide S is used as a coloring agent in solid formulations including tablets, granules, and pellets.
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Capsule, Granule / Pellet, Tablet
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Brand Name : Titanium dioxide PRETIOX AV01FG
Application : Coating Systems & Additives, 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 : Capsule, Granule / Pellet, Tablet
Grade : Oral
Brand Name : Titanium dioxide PRETIOX AV01PhG
Application : Coating Systems & Additives, Coloring Agents
Excipient Details : Titanium dioxide Pretiox AV01PhG is used as a coating and coloring agent in oral solids such as tablets, capsules, granules, and pellets.
Empty Capsules
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ABOUT THIS PAGE
62
PharmaCompass offers a list of Etilevodopa 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 Etilevodopa manufacturer or Etilevodopa supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Etilevodopa manufacturer or Etilevodopa supplier.
PharmaCompass also assists you with knowing the Etilevodopa API Price utilized in the formulation of products. Etilevodopa API Price is not always fixed or binding as the Etilevodopa Price is obtained through a variety of data sources. The Etilevodopa Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A CAS-59-92-7 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CAS-59-92-7, including repackagers and relabelers. The FDA regulates CAS-59-92-7 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CAS-59-92-7 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 CAS-59-92-7 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A CAS-59-92-7 supplier is an individual or a company that provides CAS-59-92-7 active pharmaceutical ingredient (API) or CAS-59-92-7 finished formulations upon request. The CAS-59-92-7 suppliers may include CAS-59-92-7 API manufacturers, exporters, distributors and traders.
click here to find a list of CAS-59-92-7 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A CAS-59-92-7 DMF (Drug Master File) is a document detailing the whole manufacturing process of CAS-59-92-7 active pharmaceutical ingredient (API) in detail. Different forms of CAS-59-92-7 DMFs exist exist since differing nations have different regulations, such as CAS-59-92-7 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A CAS-59-92-7 DMF submitted to regulatory agencies in the US is known as a USDMF. CAS-59-92-7 USDMF includes data on CAS-59-92-7's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The CAS-59-92-7 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of CAS-59-92-7 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 CAS-59-92-7 Drug Master File in Japan (CAS-59-92-7 JDMF) empowers CAS-59-92-7 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 CAS-59-92-7 JDMF during the approval evaluation for pharmaceutical products. At the time of CAS-59-92-7 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 CAS-59-92-7 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 CAS-59-92-7 Drug Master File in Korea (CAS-59-92-7 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of CAS-59-92-7. The MFDS reviews the CAS-59-92-7 KDMF as part of the drug registration process and uses the information provided in the CAS-59-92-7 KDMF to evaluate the safety and efficacy of the drug.
After submitting a CAS-59-92-7 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 CAS-59-92-7 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of CAS-59-92-7 suppliers with KDMF on PharmaCompass.
A CAS-59-92-7 CEP of the European Pharmacopoeia monograph is often referred to as a CAS-59-92-7 Certificate of Suitability (COS). The purpose of a CAS-59-92-7 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of CAS-59-92-7 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of CAS-59-92-7 to their clients by showing that a CAS-59-92-7 CEP has been issued for it. The manufacturer submits a CAS-59-92-7 CEP (COS) as part of the market authorization procedure, and it takes on the role of a CAS-59-92-7 CEP holder for the record. Additionally, the data presented in the CAS-59-92-7 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the CAS-59-92-7 DMF.
A CAS-59-92-7 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. CAS-59-92-7 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 CAS-59-92-7 suppliers with CEP (COS) on PharmaCompass.
A CAS-59-92-7 written confirmation (CAS-59-92-7 WC) is an official document issued by a regulatory agency to a CAS-59-92-7 manufacturer, verifying that the manufacturing facility of a CAS-59-92-7 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting CAS-59-92-7 APIs or CAS-59-92-7 finished pharmaceutical products to another nation, regulatory agencies frequently require a CAS-59-92-7 WC (written confirmation) as part of the regulatory process.
click here to find a list of CAS-59-92-7 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 CAS-59-92-7 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for CAS-59-92-7 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 CAS-59-92-7 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 CAS-59-92-7 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a CAS-59-92-7 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of CAS-59-92-7 suppliers with NDC on PharmaCompass.
CAS-59-92-7 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 CAS-59-92-7 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 CAS-59-92-7 GMP manufacturer or CAS-59-92-7 GMP API supplier for your needs.
A CAS-59-92-7 CoA (Certificate of Analysis) is a formal document that attests to CAS-59-92-7's compliance with CAS-59-92-7 specifications and serves as a tool for batch-level quality control.
CAS-59-92-7 CoA mostly includes findings from lab analyses of a specific batch. For each CAS-59-92-7 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.
CAS-59-92-7 may be tested according to a variety of international standards, such as European Pharmacopoeia (CAS-59-92-7 EP), CAS-59-92-7 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (CAS-59-92-7 USP).
