Synopsis
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VMF
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FDF
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Australia
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
US Medicaid
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Annual Reports
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Finished Drug Prices
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API SUPPLIERS
Atman Pharmaceuticals: A One Stop Solution Provider to All Your API Needs.
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
CEP/COS 
EU-WC
NDC
KDMF
ASMF, RO...
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Jai Radhe Sales is your partner for all your sourcing needs.
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USDMF
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20998
Submission : 2007-10-31
Status :
Type : II
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-19
Pay. Date : 2014-03-11
DMF Number : 14372
Submission : 1999-08-30
Status :
Type : II
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4989
Submission : 1983-06-28
Status :
Type : II
Synthokem Labs specializes in producing APIs and intermediates for the global pharma industry.
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-08
Pay. Date : 2013-09-12
DMF Number : 10413
Submission : 1993-08-13
Status :
Type : II
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14234
Submission : 1999-06-24
Status :
Type : II
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Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Certificate Number : R0-CEP 2021-332 - Rev 00
Status : Valid
Issue Date : 2021-12-10
Type : Chemical
Substance Number : 615
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Certificate Number : R1-CEP 2009-201 - Rev 03
Status : Valid
Issue Date : 2018-11-27
Type : Chemical
Substance Number : 615
Synthokem Labs specializes in producing APIs and intermediates for the global pharma industry.
Certificate Number : R1-CEP 1999-088 - Rev 05
Status : Valid
Issue Date : 2018-06-26
Type : Chemical
Substance Number : 615
Synthokem Labs specializes in producing APIs and intermediates for the global pharma industry.
Certificate Number : R0-CEP 2019-065 - Rev 00
Status : Valid
Issue Date : 2019-11-27
Type : Chemical
Substance Number : 615
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Date of Issue : 2022-06-30
Valid Till : 2025-07-02
Written Confirmation Number : WC-0028
Address of the Firm : 15A/1, IDA, Phase-III, Jeedimetla, Quthbullapur Mandai, Medchal-Malkajgiri Distr...
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Date of Issue : 2022-06-29
Valid Till : 2025-07-02
Written Confirmation Number : WC-0116
Address of the Firm : H. No. 6-5 & 6-11, Temple Road, Bonthapalli, Jinnaram Mandal, Medak Dist., Hyder...
Synthokem Labs specializes in producing APIs and intermediates for the global pharma industry.
Date of Issue : 2022-07-07
Valid Till : 2025-07-21
Written Confirmation Number : WC-0020n
Address of the Firm : B-5, Industrial Estate, Sanath Nagar, Hyderabad District -500018, Telangana, Ind...
Synthokem Labs specializes in producing APIs and intermediates for the global pharma industry.
Date of Issue : 2022-06-29
Valid Till : 2025-07-14
Written Confirmation Number : WC-0358
Address of the Firm : Unit II, Plot No. 222 to 224 and 235 to 237 Phase II IDA, Pashamylaram, Patanche...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Registrant Name : Insung Trading Co., Ltd.
Registration Date : 2021-03-09
Registration Number : 20210309-211-J-857
Manufacturer Name : Granules India Limited
Manufacturer Address : 15A/1, IDA, Phase-III, Jeedimetla, Quthbullapur Mandal, Malkajgiri Dist – 500055, T...
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Registrant Name : Daeshin Pharmaceutical Co., Ltd.
Registration Date : 2021-07-05
Registration Number : 20210309-211-J-857(2)
Manufacturer Name : Granules India Limited
Manufacturer Address : 15A/1, IDA, Phase-III, Jeedimetla, Quthbullapur Mandal, Malkajgiri Dist – 500055, T...
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Registrant Name : IMCD Korea Co., Ltd.
Registration Date : 2021-06-04
Registration Number : 20210309-211-J-857(1)
Manufacturer Name : Granules India Limited
Manufacturer Address : 15A/1, IDA, Phase-III, Jeedimetla, Quthbullapur Mandal, Malkajgiri Dist-500 055.,Tela...
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2021-11-30
Registration Number : 20210309-211-J-857(3)
Manufacturer Name : Granules India Limited
Manufacturer Address : 15A/1, IDA, Phase-III, Jeedimetla, Quthbullapur Mandal, Malkajgiri Dist – 500055, T...
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
Atman Pharmaceuticals: A One Stop Solution Provider to All Your API Needs.
About the Company : Atman Pharmaceuticals is a fully integrated pharmaceutical company that has distinguished itself as a leader in Bulk Drugs (API) marketing both domestically in India and overseas. ...
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
About the Company : Pharm-Rx has earned an outstanding reputation since its establishment in 1991, serving as a reputable importer and distributor of active ingredients to the pharmaceutical, nutritio...
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
About the Company : Granules is a vertically integrated fast-growing Pharmaceutical company headquartered in Hyderabad with best-in-class facilities & a commitment to operational excellence, quality, ...
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
About the Company : Transo-Pharm, a fully licensed and certified distributor, specializes in pharmaceutical components for the health and veterinary industries. It offers support to clients throughout...
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, ...
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
About the Company : Founded in 1987, Transo-Pharm is a fully licensed and certified global distributor of pharmaceutical components for the health and veterinary industries. The company supports its c...
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...
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
About the Company : DKSH, founded with the goal of improving people's lives, assists businesses with market expansion and business growth in both existing and emerging markets. It has been fostering g...
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 ...
Synthokem Labs specializes in producing APIs and intermediates for the global pharma industry.
About the Company : Synthokem Labs Pvt Ltd is a privately owned company established in 1978, specializing in the production of Active Pharmaceutical Ingredients and Drug Intermediates. Operating acros...
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API Imports and Exports
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Drugs in Development
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DOSAGE - SOLUTION;ORAL - 200MG/5ML;2.5MG/5ML
USFDA APPLICATION NUMBER - 205474
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1.2G...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1.2GM
USFDA APPLICATION NUMBER - 21282
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 600M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 600MG
USFDA APPLICATION NUMBER - 21282
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1.2G...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1.2GM;120MG
USFDA APPLICATION NUMBER - 21585
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 600M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 600MG;60MG
USFDA APPLICATION NUMBER - 21585
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 30MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 30MG;600MG
USFDA APPLICATION NUMBER - 21620
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 60MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 60MG;1.2GM
USFDA APPLICATION NUMBER - 21620
DOSAGE - SOLUTION;ORAL - 200MG/5ML;2.5MG/5ML;...DOSAGE - SOLUTION;ORAL - 200MG/5ML;2.5MG/5ML;30MG/5ML
USFDA APPLICATION NUMBER - 22279
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Dosage Form : Cream / Lotion / Ointment, Emulsion, Gel, Solution, Tablet
Grade : Topical, Oral
Application : API Stability Enhancers, Emulsifying Agents, Fillers, Diluents & Binders
Excipient Details : Acacia, also known as gum arabic, is used in the pharmaceutical industry as an emulsifier, stabilizing agent, & tablet binder in various formulations.
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
Brand Name : Mannogem® XL Opal
Application : Direct Compression, Fillers, Diluents & Binders, Taste Masking
Excipient Details : Mannogem® XL Opal, directly compressible 160 µm spray-dried mannitol provides superior binding properties and tabletability.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking
Excipient Details : Pharmaburst® 500 is a directly compressible pharmaceutical excipient used to create orally disintegrating tablets quickly and easily.
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 : CALCITEC PURO PH V/40S HT
Application : Fillers, Diluents & Binders
Excipient Details : Calcitec Puro PHV/40S HT is used as filler and binder in oral solid dosage forms including tablets, capsules, granules, and pellets.
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 : PIG SKIN GELATIN 140B 20M
Application : Fillers, Diluents & Binders, Thickeners and Stabilizers
Excipient Details : Pig skin gelatin 140B 20M is used as a binder and filler in pellets, granules, capsules, and tablets and as a stabilizer in parenteral products.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Dosage Form : Tablet
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : Maltodextrin is used in tablet formulations as a binder and diluent, and is particularly useful in tablet formulations.
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.
Thickeners and Stabilizers
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Dosage Form : Cream / Lotion / Ointment, Suspension
Grade : Topical
Application : API Stability Enhancers, Thickeners and Stabilizers
Excipient Details : Xanthan gum, a polysaccharide widely used in many industries as a food additive, thickening agent and stabilizer in topical formulations.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Dosage Form : Capsule, Granule / Pellet, Suspension, Syrup, Tablet
Grade : Oral
Application : Coating Systems & Additives, Fillers, Diluents & Binders, Taste Masking, Thickeners and Stabilizers
Excipient Details : Maltitol is widely used as a coating agent, diluent, sweetener and bulking agent in various dosage forms such as tablets, capsules, granules & syrups.
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Suspension
Grade : Oral
Application : Rheology Modifiers, Thickeners and Stabilizers
Excipient Details : Blanose CMC 7MF is used as a thickener and viscosity modifier in liquid formulations such as suspensions.
Pharmacopoeia Ref : EP, USP/NF
Technical Specs : N/A
Ingredient(s) : Sodium Carboxymethyl Cellulose Excipient
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
Dosage Form : Cream / Lotion / Ointment, Capsule, Gel, Tablet
Grade : Oral, Topical
Application : API Stability Enhancers, Thickeners and Stabilizers
Excipient Details : Xanthan Gum is widely used in oral dosage forms as a suspending and thickening agent. It is also used in topical formulations as stabilizer.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Dosage Form : Tablet
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : Maltodextrin is used in tablet formulations as a binder and diluent, and is particularly useful in tablet formulations.
Boai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.
Dosage Form : Capsule, Suspension, Tablet
Grade : Oral (Pharma Grade)
Application : Fillers, Diluents & Binders, Thickeners and Stabilizers
Excipient Details : KoVidone® K90 acts as a binder for tablets and capsules. It is also used as thickener and stabilizer in liquid dosage forms such as suspension.
Pharmacopoeia Ref : USP/NF, EP, JP, KP, IP, BP
Technical Specs : NA
Ingredient(s) : Polyvinylpyrrolidone K90
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Capsule, Emulsion, Suspension, Syrup, Tablet
Grade : Oral
Application : Solubilizers, Taste Masking, Thickeners and Stabilizers
Excipient Details : Complexol-B (Beta-Cyclodextrin) is used as a solubilizer, stabilizer & taste masking agent in oral syrups, suspensions, emulsions, tablets & capsules.
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Cream / Lotion / Ointment, Emulsion, Gel, Injectable / Parenteral, Suspension, Tablet
Grade : Parenteral, Oral, Topical
Application : Emulsifying Agents, Parenteral, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical
Excipient Details : Polysorbate 20 is used in parenteral products such as biologics. It is used as a solubilizer, surfactant, emulsifier & suspension stabilizer.
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.
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
Dosage Form : Injectable / Parenteral, Tablet
Grade : Parenteral, Oral
Application : Fillers, Diluents & Binders, Parenteral, Thickeners and Stabilizers
Excipient Details : D-mannitol protects proteins from denaturation & degradation. It is also used as a stabilizer in liquid formulations & as a bulking agent in tablets.
Solubilizers
Coating Systems & Additives
Direct Compression
Taste Masking
Topical
Controlled & Modified Release
Disintegrants & Superdisintegrants
Parenteral
Granulation
Film Formers & Plasticizers
Lubricants & Glidants
Chewable & Orodispersible Aids
Co-Processed Excipients
Emulsifying Agents
Rheology Modifiers
API Stability Enhancers
Surfactant & Foaming Agents
Empty Capsules
Coloring Agents
Vegetarian Capsules
Soft Gelatin
Digital Content
NEWS #PharmaBuzz
Market Place
US Patents
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ANALYTICAL
ABOUT THIS PAGE
A Guaifenesin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Guaifenesin, including repackagers and relabelers. The FDA regulates Guaifenesin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Guaifenesin 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 Guaifenesin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Guaifenesin supplier is an individual or a company that provides Guaifenesin active pharmaceutical ingredient (API) or Guaifenesin finished formulations upon request. The Guaifenesin suppliers may include Guaifenesin API manufacturers, exporters, distributors and traders.
click here to find a list of Guaifenesin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Guaifenesin DMF (Drug Master File) is a document detailing the whole manufacturing process of Guaifenesin active pharmaceutical ingredient (API) in detail. Different forms of Guaifenesin DMFs exist exist since differing nations have different regulations, such as Guaifenesin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Guaifenesin DMF submitted to regulatory agencies in the US is known as a USDMF. Guaifenesin USDMF includes data on Guaifenesin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Guaifenesin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Guaifenesin 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 Guaifenesin Drug Master File in Japan (Guaifenesin JDMF) empowers Guaifenesin 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 Guaifenesin JDMF during the approval evaluation for pharmaceutical products. At the time of Guaifenesin 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 Guaifenesin 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 Guaifenesin Drug Master File in Korea (Guaifenesin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Guaifenesin. The MFDS reviews the Guaifenesin KDMF as part of the drug registration process and uses the information provided in the Guaifenesin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Guaifenesin 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 Guaifenesin API can apply through the Korea Drug Master File (KDMF).
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A Guaifenesin CEP of the European Pharmacopoeia monograph is often referred to as a Guaifenesin Certificate of Suitability (COS). The purpose of a Guaifenesin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Guaifenesin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Guaifenesin to their clients by showing that a Guaifenesin CEP has been issued for it. The manufacturer submits a Guaifenesin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Guaifenesin CEP holder for the record. Additionally, the data presented in the Guaifenesin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Guaifenesin DMF.
A Guaifenesin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Guaifenesin 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 Guaifenesin suppliers with CEP (COS) on PharmaCompass.
A Guaifenesin written confirmation (Guaifenesin WC) is an official document issued by a regulatory agency to a Guaifenesin manufacturer, verifying that the manufacturing facility of a Guaifenesin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Guaifenesin APIs or Guaifenesin finished pharmaceutical products to another nation, regulatory agencies frequently require a Guaifenesin WC (written confirmation) as part of the regulatory process.
click here to find a list of Guaifenesin 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 Guaifenesin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Guaifenesin 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 Guaifenesin 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 Guaifenesin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Guaifenesin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Guaifenesin suppliers with NDC on PharmaCompass.
Guaifenesin 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 Guaifenesin 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 Guaifenesin GMP manufacturer or Guaifenesin GMP API supplier for your needs.
A Guaifenesin CoA (Certificate of Analysis) is a formal document that attests to Guaifenesin's compliance with Guaifenesin specifications and serves as a tool for batch-level quality control.
Guaifenesin CoA mostly includes findings from lab analyses of a specific batch. For each Guaifenesin 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.
Guaifenesin may be tested according to a variety of international standards, such as European Pharmacopoeia (Guaifenesin EP), Guaifenesin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Guaifenesin USP).
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