Synopsis
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VMF
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Australia
DRUG PRODUCT COMPOSITIONS0
US Patents
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US Exclusivities
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Health Canada Patents
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FDF
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Jai Radhe Sales is your partner for all your sourcing needs.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
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.
EU-WC
NDC
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
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
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Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
CAS Number : 1210-35-1
End Use API : Amitriptyline Hydrochloride
About The Company : Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for...
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Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 10mg
Packaging : Pack Size 10x10
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 25mg
Packaging : Pack Size 10x10
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 10mg/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name : Amitriptyline Hydrochl...
Dosage Form : DC Granules
Dosage Strength : 25MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name : Amitriptyline Hydrochl...
Dosage Form : DC Granules
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name : Amitriptyline Hydrochl...
Dosage Form : DC Granules
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
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DOSAGE - TABLET;ORAL - 100MG
USFDA APPLICATION NUMBER - 85968
DOSAGE - TABLET;ORAL - 10MG
USFDA APPLICATION NUMBER - 85968
DOSAGE - TABLET;ORAL - 150MG
USFDA APPLICATION NUMBER - 85968
DOSAGE - TABLET;ORAL - 25MG
USFDA APPLICATION NUMBER - 85968
DOSAGE - TABLET;ORAL - 50MG
USFDA APPLICATION NUMBER - 85968
DOSAGE - TABLET;ORAL - 75MG
USFDA APPLICATION NUMBER - 85968
Related Excipient Companies
Rochem International Inc
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Coating Systems & Additives
Controlled & Modified Release
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Coating Systems & Additives, Controlled & Modified Release
Excipient Details : ACTILLETS are microcrystalline cellulose spheres developed using advanced drug delivery technology to enable effective loading & coating of particles.
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Softgel Capsule, Softgels
Grade : Parenteral, Topical, Oral
Brand Name : Polyethylene Glycol 400
Application : Fillers, Diluents & Binders, Film Formers & Plasticizers, Parenteral, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical
Excipient Details : PEG 400 is used as a suspending agent, stabilizer, plasticizer and filler in OSDs, liquids & semi-solids and as a solvent for parenteral formulations.
Disintegrants & Superdisintegrants
Thickeners and Stabilizers
Granulation
Solubilizers
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Capsule, Granule / Pellet, Tablet
Grade : Oral
Application : Solubilizers
Excipient Details : HPC-SSL SFP is used as a binder and solubilizer in solid dosage forms including tablets, capsules, granules, and pellets.
Pharmacopoeia Ref : EP, JP, USP/NF, CEP, GMP, Hala...
Technical Specs : N/A
Ingredient(s) : Hydroxypropyl Cellulose
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Emulsion, Injectable / Parenteral
Grade : Parenteral
Application : Emulsifying Agents, Parenteral, Solubilizers
Excipient Details : Soya lecithin is used as solubilizer & emulsifier in parenteral dosage forms such as fat emulsion injections, mixed micelle preparations & emulsions.
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Capsule, Cream / Lotion / Ointment, Emulsion, Gel, Injectable / Parenteral, Suspension, Tablet
Grade : Parenteral, Oral, Topical
Application : Emulsifying Agents, Film Formers & Plasticizers, Parenteral, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical
Excipient Details : Polysorbate 80 is used as a plasticizer, solubilizer, emulsifier, surfactant, and suspension stabilizer. It is also used in parenteral products.
Direct Compression
Topical
Co-Processed Excipients
Lubricants & Glidants
Parenteral
Film Formers & Plasticizers
Taste Masking
Rheology Modifiers
Emulsifying Agents
API Stability Enhancers
Chewable & Orodispersible Aids
Coloring Agents
Empty Capsules
Surfactant & Foaming Agents
Vegetarian Capsules
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Amitriptyline Hydrochloride 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 Amitriptyline Hydrochloride manufacturer or Amitriptyline Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Amitriptyline Hydrochloride manufacturer or Amitriptyline Hydrochloride supplier.
PharmaCompass also assists you with knowing the Amitriptyline Hydrochloride API Price utilized in the formulation of products. Amitriptyline Hydrochloride API Price is not always fixed or binding as the Amitriptyline Hydrochloride Price is obtained through a variety of data sources. The Amitriptyline Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Sarotena manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sarotena, including repackagers and relabelers. The FDA regulates Sarotena manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sarotena 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 Sarotena manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sarotena supplier is an individual or a company that provides Sarotena active pharmaceutical ingredient (API) or Sarotena finished formulations upon request. The Sarotena suppliers may include Sarotena API manufacturers, exporters, distributors and traders.
click here to find a list of Sarotena suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sarotena DMF (Drug Master File) is a document detailing the whole manufacturing process of Sarotena active pharmaceutical ingredient (API) in detail. Different forms of Sarotena DMFs exist exist since differing nations have different regulations, such as Sarotena USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sarotena DMF submitted to regulatory agencies in the US is known as a USDMF. Sarotena USDMF includes data on Sarotena's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sarotena USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sarotena 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 Sarotena Drug Master File in Japan (Sarotena JDMF) empowers Sarotena 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 Sarotena JDMF during the approval evaluation for pharmaceutical products. At the time of Sarotena 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 Sarotena 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 Sarotena Drug Master File in Korea (Sarotena KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sarotena. The MFDS reviews the Sarotena KDMF as part of the drug registration process and uses the information provided in the Sarotena KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sarotena 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 Sarotena API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sarotena suppliers with KDMF on PharmaCompass.
A Sarotena CEP of the European Pharmacopoeia monograph is often referred to as a Sarotena Certificate of Suitability (COS). The purpose of a Sarotena CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sarotena EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sarotena to their clients by showing that a Sarotena CEP has been issued for it. The manufacturer submits a Sarotena CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sarotena CEP holder for the record. Additionally, the data presented in the Sarotena CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sarotena DMF.
A Sarotena CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sarotena 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 Sarotena suppliers with CEP (COS) on PharmaCompass.
A Sarotena written confirmation (Sarotena WC) is an official document issued by a regulatory agency to a Sarotena manufacturer, verifying that the manufacturing facility of a Sarotena active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sarotena APIs or Sarotena finished pharmaceutical products to another nation, regulatory agencies frequently require a Sarotena WC (written confirmation) as part of the regulatory process.
click here to find a list of Sarotena 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 Sarotena as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sarotena 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 Sarotena 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 Sarotena and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sarotena NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sarotena suppliers with NDC on PharmaCompass.
Sarotena 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 Sarotena 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 Sarotena GMP manufacturer or Sarotena GMP API supplier for your needs.
A Sarotena CoA (Certificate of Analysis) is a formal document that attests to Sarotena's compliance with Sarotena specifications and serves as a tool for batch-level quality control.
Sarotena CoA mostly includes findings from lab analyses of a specific batch. For each Sarotena 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.
Sarotena may be tested according to a variety of international standards, such as European Pharmacopoeia (Sarotena EP), Sarotena JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sarotena USP).
