Synopsis
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CEP/COS
0
JDMF
0
EU WC
0
VMF
0
Europe
0
Australia
0
South Africa
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
Veranova: A CDMO that manages complexity with confidence.
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Temad- We think of world-class quality.
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
NDC
Parand Darou is a knowledge-based company, focused on the production of Narcotic APIs.
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
NDC
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USDMF
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-23
Pay. Date : 2013-04-09
DMF Number : 19848
Submission : 2006-10-03
Status :
Type : II
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-31
Pay. Date : 2014-03-20
DMF Number : 23681
Submission : 2010-03-31
Status :
Type : II
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-08
Pay. Date : 2012-11-23
DMF Number : 21158
Submission : 2007-12-18
Status :
Type : II
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Temad- We think of world-class quality.
CAS Number : 3861-72-1
End Use API : Hydrocodone Bitartrate
About The Company : Established in 1997, Temad Co. is one of the largest producers of APIs in Iran & an innovative manufacturer of narcotic and non-narcotic products of world-class...
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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 10M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 10MG
USFDA APPLICATION NUMBER - 202880
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 15M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 15MG
USFDA APPLICATION NUMBER - 202880
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 20M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 20MG
USFDA APPLICATION NUMBER - 202880
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 30M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 30MG
USFDA APPLICATION NUMBER - 202880
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 40M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 40MG
USFDA APPLICATION NUMBER - 202880
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 50M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 50MG
USFDA APPLICATION NUMBER - 202880
DOSAGE - SOLUTION;ORAL - 4MG/5ML;5MG/5ML
USFDA APPLICATION NUMBER - 204307
DOSAGE - SOLUTION;ORAL - 200MG/5ML;2.5MG/5ML
USFDA APPLICATION NUMBER - 205474
DOSAGE - SOLUTION;ORAL - 200MG/5ML;2.5MG/5ML;...DOSAGE - SOLUTION;ORAL - 200MG/5ML;2.5MG/5ML;30MG/5ML
USFDA APPLICATION NUMBER - 22279
DOSAGE - SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG...DOSAGE - SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22439
DOSAGE - SOLUTION;ORAL - 5MG/5ML;60MG/5ML **F...DOSAGE - SOLUTION;ORAL - 5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22442
DOSAGE - TABLET;ORAL - 1.5MG;5MG
USFDA APPLICATION NUMBER - 5213
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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
Coating Systems & Additives
Direct Compression
Controlled & Modified Release
Disintegrants & Superdisintegrants
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 : Croscarmellose Sodium
Application : Disintegrants & Superdisintegrants
Excipient Details : Croscarmellose sodium is used as a super disintegrant in various oral solid dosage forms, such as tablets and ODTs.
Boai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.
Dosage Form : Tablet
Grade : Oral (Pharma Grade)
Brand Name : PolyKoVidone Ultra XL
Application : Disintegrants & Superdisintegrants
Excipient Details : PolyKoVidone Ultra XL is used as a superdisintegrant and solid dispersant aid in solid dosage forms such as tablets.
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Capsule, Granule / Pellet, Tablet
Grade : Oral
Application : Direct Compression, Disintegrants & Superdisintegrants
Excipient Details : Solvostar (Sodium Starch Glycolate) is used as a superdisintegrant and directly compressible excipient in tablets, capsules, suspensions, and pellets.
Pharmacopoeia Ref : IP/BP/EP/USP-NF
Technical Specs : Solvostar 2% to 8%
Ingredient(s) : Sodium Starch Glycolate
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Brand Name : Innogel 9000/9500
Application : Disintegrants & Superdisintegrants, Fillers, Diluents & Binders
Excipient Details : Innogel 9000/9500 (Pregelatinized Starch) is used as filler, binder, disintegrant, and superdisintegrant in tablets and capsules.
Pharmacopoeia Ref : IP/BP/EP/USP-NF
Technical Specs : NA
Ingredient(s) : Corn Starch, Pregelatinized
Boai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.
Dosage Form : Tablet
Grade : Oral (Pharma Grade)
Brand Name : PolyKoVidone Ultra XL-10
Application : Disintegrants & Superdisintegrants
Excipient Details : PolyKoVidone Ultra XL-10 is used as a superdisintegrant and solid dispersant aid in solid dosage forms such as tablets.
Boai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.
Dosage Form : Tablet
Grade : Oral (Pharma Grade)
Application : Disintegrants & Superdisintegrants
Excipient Details : PolyKoVidone XL is used as a superdisintegrant and solid dispersant aid in solid dosage forms such as tablets.
Boai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.
Dosage Form : Tablet
Grade : Oral (Pharma Grade)
Brand Name : PolyKoVidone XL-10
Application : Disintegrants & Superdisintegrants
Excipient Details : PolyKoVidone XL-10 is used as a superdisintegrant and solid dispersant aid in solid dosage forms such as tablets.
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Capsule, Granule / Pellet, Tablet
Grade : Oral
Application : Disintegrants & Superdisintegrants
Excipient Details : Sallyso (Croscarmellose Sodium) is used as a disintegrating agent in tablets, capsules & granules for enhancing API dissolution and bioavailability.
Pharmacopoeia Ref : IP/BP/EP/USP-NF
Technical Specs : Sallyso 0.5 to 3.0%
Ingredient(s) : Croscarmellose Sodium
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Application : Co-Processed Excipients, Direct Compression, Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Lubricants & Glidants
Excipient Details : ProBlend (Microcrystalline Cellulose) is used as a filler, binder, glidant, DC & co-processed excipient in tablets, capsules, and MUPS formulations.
Thickeners and Stabilizers
Granulation
Film Formers & Plasticizers
Solubilizers
Taste Masking
Parenteral
Topical
Lubricants & Glidants
Co-Processed Excipients
Chewable & Orodispersible Aids
Emulsifying Agents
Empty Capsules
API Stability Enhancers
Rheology Modifiers
Coloring Agents
Vegetarian Capsules
Surfactant & Foaming Agents
Soft Gelatin
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Hydrocodone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hydrocodone, including repackagers and relabelers. The FDA regulates Hydrocodone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hydrocodone 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 Hydrocodone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hydrocodone supplier is an individual or a company that provides Hydrocodone active pharmaceutical ingredient (API) or Hydrocodone finished formulations upon request. The Hydrocodone suppliers may include Hydrocodone API manufacturers, exporters, distributors and traders.
click here to find a list of Hydrocodone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Hydrocodone DMF (Drug Master File) is a document detailing the whole manufacturing process of Hydrocodone active pharmaceutical ingredient (API) in detail. Different forms of Hydrocodone DMFs exist exist since differing nations have different regulations, such as Hydrocodone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hydrocodone DMF submitted to regulatory agencies in the US is known as a USDMF. Hydrocodone USDMF includes data on Hydrocodone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hydrocodone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hydrocodone 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 Hydrocodone Drug Master File in Korea (Hydrocodone KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Hydrocodone. The MFDS reviews the Hydrocodone KDMF as part of the drug registration process and uses the information provided in the Hydrocodone KDMF to evaluate the safety and efficacy of the drug.
After submitting a Hydrocodone 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 Hydrocodone API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Hydrocodone suppliers with KDMF 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 Hydrocodone as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Hydrocodone 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 Hydrocodone 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 Hydrocodone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Hydrocodone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Hydrocodone suppliers with NDC on PharmaCompass.
Hydrocodone 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 Hydrocodone 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 Hydrocodone GMP manufacturer or Hydrocodone GMP API supplier for your needs.
A Hydrocodone CoA (Certificate of Analysis) is a formal document that attests to Hydrocodone's compliance with Hydrocodone specifications and serves as a tool for batch-level quality control.
Hydrocodone CoA mostly includes findings from lab analyses of a specific batch. For each Hydrocodone 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.
Hydrocodone may be tested according to a variety of international standards, such as European Pharmacopoeia (Hydrocodone EP), Hydrocodone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Hydrocodone USP).
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