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DRUG PRODUCT COMPOSITIONS0
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Data Compilation #PharmaFlow
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API SUPPLIERS
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USDMF
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Drugs in Development
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DOSAGE - TABLET;ORAL - 37.5MG
USFDA APPLICATION NUMBER - 85128
DOSAGE - CAPSULE;ORAL - 30MG
USFDA APPLICATION NUMBER - 86945
DOSAGE - CAPSULE;ORAL - 15MG
USFDA APPLICATION NUMBER - 87190
DOSAGE - CAPSULE;ORAL - 30MG
USFDA APPLICATION NUMBER - 87190
DOSAGE - CAPSULE;ORAL - 37.5MG
USFDA APPLICATION NUMBER - 88023
Related Excipient Companies
Minakem
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
Dosage Form : Capsule
Grade : Oral
Brand Name : Sodium Stearyl Fumarate G...
Application : Lubricants & Glidants
Excipient Details : Sodium Stearyl Fumarate is used as a lubricant in OSDs to reduce the friction and the adhesion. It also provides tablet strength & disintegration.
Pharmacopoeia Ref : USP, EP, ICH, Q7GMP
Technical Specs : NA
Ingredient(s) : Sodium Stearyl Fumarate
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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 : Granule / Pellet, Tablet
Grade : Oral
Application : Fillers, Diluents & Binders, Granulation, Solubilizers
Excipient Details : Mannogem (mannitol powder) is an excellent excipient for use in wet granulation, lyophilization & improves solubility of poorly soluble APIs.
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Capsule, Granule / Pellet, Tablet, Injectable / Parenteral
Grade : Parenteral, Oral
Brand Name : GELATIN BOVINE 140B 6M
Application : Fillers, Diluents & Binders, Thickeners and Stabilizers
Excipient Details : Gelatin bovine 140B 6M is used as a stabilizer in parenteral drug products and as a binder and filler in capsules, tablets, granules, and pellets.
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
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.
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.
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.
Dosage Form : Tablet
Grade : Oral
Application : Co-Processed Excipients, Fillers, Diluents & Binders
Excipient Details : Starlose P40 (Starch & Lactose Monohydrate) is used as a diluent in oral dosage forms such as tablets.
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Tablet
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : Mpressol (Mannitol) is a polyol used as a filler in tablet formulations, sugar-free solutions and as a bulking agent in freeze-dried products.
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Injectable / Parenteral
Grade : Parenteral
Brand Name : Lactose Monohydrate
Application : Parenteral
Excipient Details : Lactose monohydrate is used as a diluent in inhalation and lyophilized preparations.
Coating Systems & Additives
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.
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 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
Chynops Pharma is an ideal sourcing partner for high-quality APIs, advanced intermediates, speciality chemicals & excipients.
Brand Name : Sodium Stearyl Fumarate
Application : Lubricants & Glidants
Excipient Details : Sodium stearyl fumarate is used as a lubricant to reduce friction and adhesion in pharmaceutical solid oral formulations such as tablets and capsules.
Pharmacopoeia Ref : IH/BP/USP
Technical Specs : NA
Ingredient(s) : Sodium Stearyl Fumarate Excipient
Delivering high-quality, innovative solutions with regulatory excellence for the healthcare and chemical industries worldwide.
Brand Name : Sodium Stearyl Fumarate
Application : Lubricants & Glidants
Excipient Details : Sodium Stearyl Fumarate is used as a lubricant in OSDs to reduce the friction and the adhesion. It also provides tablet strength and disintegration.
Delivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.
Dosage Form : Tablet
Grade : Oral
Brand Name : Sodium Stearyl Fumarate
Application : Lubricants & Glidants
Excipient Details : Sodium Stearyl Fumarate is used as a lubricant in oral solid dosage forms to reduce the friction and the adhesion.
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.
Direct Compression
Thickeners and Stabilizers
Disintegrants & Superdisintegrants
Granulation
Controlled & Modified Release
Solubilizers
Taste Masking
Lubricants & Glidants
Chewable & Orodispersible Aids
Co-Processed Excipients
Film Formers & Plasticizers
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Parenteral
Empty Capsules
Emulsifying Agents
Rheology Modifiers
API Stability Enhancers
Coloring Agents
Vegetarian Capsules
Surfactant & Foaming Agents
Digital Content
NEWS #PharmaBuzz
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US Medicaid Prescriptions
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PharmaCompass offers a list of Phentermine 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 Phentermine Hydrochloride manufacturer or Phentermine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Phentermine Hydrochloride manufacturer or Phentermine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Phentermine Hydrochloride API Price utilized in the formulation of products. Phentermine Hydrochloride API Price is not always fixed or binding as the Phentermine Hydrochloride Price is obtained through a variety of data sources. The Phentermine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 2-methyl-1-phenylpropan-2-amine;hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 2-methyl-1-phenylpropan-2-amine;hydrochloride, including repackagers and relabelers. The FDA regulates 2-methyl-1-phenylpropan-2-amine;hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 2-methyl-1-phenylpropan-2-amine;hydrochloride 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 2-methyl-1-phenylpropan-2-amine;hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 2-methyl-1-phenylpropan-2-amine;hydrochloride supplier is an individual or a company that provides 2-methyl-1-phenylpropan-2-amine;hydrochloride active pharmaceutical ingredient (API) or 2-methyl-1-phenylpropan-2-amine;hydrochloride finished formulations upon request. The 2-methyl-1-phenylpropan-2-amine;hydrochloride suppliers may include 2-methyl-1-phenylpropan-2-amine;hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of 2-methyl-1-phenylpropan-2-amine;hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 2-methyl-1-phenylpropan-2-amine;hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of 2-methyl-1-phenylpropan-2-amine;hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of 2-methyl-1-phenylpropan-2-amine;hydrochloride DMFs exist exist since differing nations have different regulations, such as 2-methyl-1-phenylpropan-2-amine;hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 2-methyl-1-phenylpropan-2-amine;hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. 2-methyl-1-phenylpropan-2-amine;hydrochloride USDMF includes data on 2-methyl-1-phenylpropan-2-amine;hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 2-methyl-1-phenylpropan-2-amine;hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 2-methyl-1-phenylpropan-2-amine;hydrochloride suppliers with USDMF 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 2-methyl-1-phenylpropan-2-amine;hydrochloride Drug Master File in Korea (2-methyl-1-phenylpropan-2-amine;hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 2-methyl-1-phenylpropan-2-amine;hydrochloride. The MFDS reviews the 2-methyl-1-phenylpropan-2-amine;hydrochloride KDMF as part of the drug registration process and uses the information provided in the 2-methyl-1-phenylpropan-2-amine;hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a 2-methyl-1-phenylpropan-2-amine;hydrochloride 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 2-methyl-1-phenylpropan-2-amine;hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of 2-methyl-1-phenylpropan-2-amine;hydrochloride suppliers with KDMF on PharmaCompass.
A 2-methyl-1-phenylpropan-2-amine;hydrochloride written confirmation (2-methyl-1-phenylpropan-2-amine;hydrochloride WC) is an official document issued by a regulatory agency to a 2-methyl-1-phenylpropan-2-amine;hydrochloride manufacturer, verifying that the manufacturing facility of a 2-methyl-1-phenylpropan-2-amine;hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 2-methyl-1-phenylpropan-2-amine;hydrochloride APIs or 2-methyl-1-phenylpropan-2-amine;hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a 2-methyl-1-phenylpropan-2-amine;hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of 2-methyl-1-phenylpropan-2-amine;hydrochloride 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 2-methyl-1-phenylpropan-2-amine;hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 2-methyl-1-phenylpropan-2-amine;hydrochloride 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 2-methyl-1-phenylpropan-2-amine;hydrochloride 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 2-methyl-1-phenylpropan-2-amine;hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 2-methyl-1-phenylpropan-2-amine;hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of 2-methyl-1-phenylpropan-2-amine;hydrochloride suppliers with NDC on PharmaCompass.
2-methyl-1-phenylpropan-2-amine;hydrochloride 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 2-methyl-1-phenylpropan-2-amine;hydrochloride 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 2-methyl-1-phenylpropan-2-amine;hydrochloride GMP manufacturer or 2-methyl-1-phenylpropan-2-amine;hydrochloride GMP API supplier for your needs.
A 2-methyl-1-phenylpropan-2-amine;hydrochloride CoA (Certificate of Analysis) is a formal document that attests to 2-methyl-1-phenylpropan-2-amine;hydrochloride's compliance with 2-methyl-1-phenylpropan-2-amine;hydrochloride specifications and serves as a tool for batch-level quality control.
2-methyl-1-phenylpropan-2-amine;hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each 2-methyl-1-phenylpropan-2-amine;hydrochloride 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.
2-methyl-1-phenylpropan-2-amine;hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (2-methyl-1-phenylpropan-2-amine;hydrochloride EP), 2-methyl-1-phenylpropan-2-amine;hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (2-methyl-1-phenylpropan-2-amine;hydrochloride USP).
