Synopsis
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CEP/COS
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JDMF
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EU WC
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KDMF
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EDQM
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USP
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JP
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Others
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Europe
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Canada
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Australia
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South Africa
DRUG PRODUCT COMPOSITIONS
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FDF
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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API SUPPLIERS
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
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Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
Mesochem is focused on incessant innovation along with the R&D of new APIs.
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USDMF
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36707
Submission : 2022-06-01
Status :
Type : II
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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 ...
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
About the Company : Symbiotec, a leading API manufacturing company based in Indore, Central India, specializes in Cortico-Steroids and Steroid-Hormone APIs. Since 1995, their focus on R&D, sustainable...
Mesochem is focused on incessant innovation along with the R&D of new APIs.
About the Company : Beijing Mesochem Technology Co. Ltd., which is located in the national economic and technological development area of Yizhuang, China, manufactures pharmaceutical chemicals, fine c...
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API Imports and Exports
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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
SPI Pharma
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Controlled & Modified Release
Excipient Details : ACTILLETS are microcrystalline cellulose spheres developed using advanced drug delivery technology to enable effective loading & coating of particles.
Pharmacopoeia Ref : NA
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose Excipients
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 : 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 : Capsule
Grade : Oral, Topical
Brand Name : NATROSOL 250 G PHARM
Application : Rheology Modifiers
Excipient Details : Natrosol 250 G Pharm is used as thickener & viscosity modifier in tablets, capsules, granules, syrups, solutions & suspensions & in topical solutions.
Pharmacopoeia Ref : USP, EP, JP
Technical Specs : N/A
Ingredient(s) : Hydroxyethyl Cellulose Excipient
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Capsule
Grade : Oral, Topical
Brand Name : NATROSOL 250 H PHARM
Application : Rheology Modifiers
Excipient Details : Natrosol 250 H Pharm is used as a viscosity modifier and thickener in granules, pellets, tablets, capsules, and topical formulations.
Pharmacopoeia Ref : USP, EP, JP
Technical Specs : N/A
Ingredient(s) : Hydroxyethyl Cellulose Excipient
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Capsule
Grade : Oral, Topical
Brand Name : NATROSOL 250 HHX PHARM
Application : Rheology Modifiers
Excipient Details : Natrosol 250 HHX Pharm is used as a thickener and viscosity modifier in topical formulations, granules, pellets, tablets, and capsules.
Pharmacopoeia Ref : USP, EP, JP
Technical Specs : N/A
Ingredient(s) : Hydroxyethyl Cellulose Excipient
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 : 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) : Microcrystalline Cellulose Excipients
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nitika Pharmaceutical Specialities
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Silverline Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Thickeners and Stabilizers
Topical
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Capsule, Tablet, Solution, Suspension, Syrup
Grade : Oral, Topical
Brand Name : NATROSOL 250 G PHARM
Application : Rheology Modifiers, Thickeners and Stabilizers, Topical
Excipient Details : Natrosol 250 G Pharm is used as thickener & viscosity modifier in tablets, capsules, granules, syrups, solutions & suspensions & in topical solutions.
Pharmacopoeia Ref : USP, EP, JP
Technical Specs : N/A
Ingredient(s) : Hydroxyethyl Cellulose Excipient
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Tablet
Grade : Parenteral, Oral, Topical
Application : Parenteral, Solubilizers, Topical
Excipient Details : Benzyl alcohol is used as a bacteriostatic & preservative in parenteral & ophthalmic products. It is widely used in oral & topical formulations.
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Emulsion
Grade : Topical
Brand Name : Polyoxyl 25 Cetostearyl Ether
Application : Emulsifying Agents, Surfactant & Foaming Agents, Topical
Excipient Details : Cetostearyl alcohol polyoxyethylene (25) ether is used as a surfactant and emulsifying agent in topical formulations, mainly in emulsions.
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Softgels
Grade : Parenteral, Oral, Topical
Application : Film Formers & Plasticizers, Parenteral, Thickeners and Stabilizers, Topical
Excipient Details : Propylene glycol is used as a solvent & stabilizer in injections. It is also used in topical semi-solids & as a plasticizer in soft capsules.
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Capsule, Tablet, Solution, Suspension, Syrup
Grade : Oral, Topical
Brand Name : NATROSOL 250 H PHARM
Application : Rheology Modifiers, Thickeners and Stabilizers, Topical
Excipient Details : Natrosol 250 H Pharm is used as a viscosity modifier and thickener in granules, pellets, tablets, capsules, and topical formulations.
Pharmacopoeia Ref : USP, EP, JP
Technical Specs : N/A
Ingredient(s) : Hydroxyethyl Cellulose Excipient
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Capsule, Tablet, Solution, Suspension, Syrup
Grade : Oral, Topical
Brand Name : NATROSOL 250 HHX PHARM
Application : Rheology Modifiers, Thickeners and Stabilizers, Topical
Excipient Details : Natrosol 250 HHX Pharm is used as a thickener and viscosity modifier in topical formulations, granules, pellets, tablets, and capsules.
Pharmacopoeia Ref : USP, EP, JP
Technical Specs : N/A
Ingredient(s) : Hydroxyethyl Cellulose Excipient
Disintegrants & Superdisintegrants
Lubricants & Glidants
Direct Compression
Co-Processed Excipients
Granulation
Emulsifying Agents
Rheology Modifiers
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Capsule, Tablet, Solution, Suspension, Syrup
Grade : Oral, Topical
Brand Name : NATROSOL 250 G PHARM
Application : Rheology Modifiers, Thickeners and Stabilizers, Topical
Excipient Details : Natrosol 250 G Pharm is used as thickener & viscosity modifier in tablets, capsules, granules, syrups, solutions & suspensions & in topical solutions.
Pharmacopoeia Ref : USP, EP, JP
Technical Specs : N/A
Ingredient(s) : Hydroxyethyl Cellulose Excipient
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Capsule, Tablet, Solution, Suspension, Syrup
Grade : Oral, Topical
Brand Name : NATROSOL 250 H PHARM
Application : Rheology Modifiers, Thickeners and Stabilizers, Topical
Excipient Details : Natrosol 250 H Pharm is used as a viscosity modifier and thickener in granules, pellets, tablets, capsules, and topical formulations.
Pharmacopoeia Ref : USP, EP, JP
Technical Specs : N/A
Ingredient(s) : Hydroxyethyl Cellulose Excipient
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Capsule, Tablet, Solution, Suspension, Syrup
Grade : Oral, Topical
Brand Name : NATROSOL 250 HHX PHARM
Application : Rheology Modifiers, Thickeners and Stabilizers, Topical
Excipient Details : Natrosol 250 HHX Pharm is used as a thickener and viscosity modifier in topical formulations, granules, pellets, tablets, and capsules.
Pharmacopoeia Ref : USP, EP, JP
Technical Specs : N/A
Ingredient(s) : Hydroxyethyl Cellulose Excipient
Controlled & Modified Release
Chewable & Orodispersible Aids
Film Formers & Plasticizers
Solubilizers
Coating Systems & Additives
Parenteral
Taste Masking
Surfactant & Foaming Agents
API Stability Enhancers
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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ABOUT THIS PAGE
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PharmaCompass offers a list of Spinosyn D 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 Spinosyn D manufacturer or Spinosyn D supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Spinosyn D manufacturer or Spinosyn D supplier.
PharmaCompass also assists you with knowing the Spinosyn D API Price utilized in the formulation of products. Spinosyn D API Price is not always fixed or binding as the Spinosyn D Price is obtained through a variety of data sources. The Spinosyn D Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Spinosad manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Spinosad, including repackagers and relabelers. The FDA regulates Spinosad manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Spinosad 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 Spinosad manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Spinosad supplier is an individual or a company that provides Spinosad active pharmaceutical ingredient (API) or Spinosad finished formulations upon request. The Spinosad suppliers may include Spinosad API manufacturers, exporters, distributors and traders.
click here to find a list of Spinosad suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Spinosad DMF (Drug Master File) is a document detailing the whole manufacturing process of Spinosad active pharmaceutical ingredient (API) in detail. Different forms of Spinosad DMFs exist exist since differing nations have different regulations, such as Spinosad USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Spinosad DMF submitted to regulatory agencies in the US is known as a USDMF. Spinosad USDMF includes data on Spinosad's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Spinosad USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Spinosad suppliers with USDMF 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 Spinosad as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Spinosad 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 Spinosad 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 Spinosad and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Spinosad NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Spinosad suppliers with NDC on PharmaCompass.
Spinosad 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 Spinosad 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 Spinosad GMP manufacturer or Spinosad GMP API supplier for your needs.
A Spinosad CoA (Certificate of Analysis) is a formal document that attests to Spinosad's compliance with Spinosad specifications and serves as a tool for batch-level quality control.
Spinosad CoA mostly includes findings from lab analyses of a specific batch. For each Spinosad 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.
Spinosad may be tested according to a variety of international standards, such as European Pharmacopoeia (Spinosad EP), Spinosad JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Spinosad USP).
