Synopsis
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CEP/COS
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JDMF
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EU WC
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VMF
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Europe
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Australia
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South Africa
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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API SUPPLIERS
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USDMF
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Veranova: A CDMO that manages complexity with confidence.
About the Company : Veranova is a global leader in the development and manufacturing of specialist and complex APIs for pharma and biotech customers. We have over 50 years of experience navigating the...
Temad- We think of world-class quality.
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 quality in the Midd...
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
About the Company : Rusan Pharma is a fully integrated global pharmaceutical company specializing in the treatment of addiction & pain management. We manufacture & market a wide range of APIs & formul...
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
About the Company : Founded in 1979, Noramco specializes in the development and manufacturing of APIs for both opioid and non-opioid products. With expertise in controlled substance development and ma...
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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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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Hydrocodone Bitartrate 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 Hydrocodone Bitartrate manufacturer or Hydrocodone Bitartrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Hydrocodone Bitartrate manufacturer or Hydrocodone Bitartrate supplier.
PharmaCompass also assists you with knowing the Hydrocodone Bitartrate API Price utilized in the formulation of products. Hydrocodone Bitartrate API Price is not always fixed or binding as the Hydrocodone Bitartrate Price is obtained through a variety of data sources. The Hydrocodone Bitartrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Hycon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hycon, including repackagers and relabelers. The FDA regulates Hycon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hycon 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 Hycon manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hycon supplier is an individual or a company that provides Hycon active pharmaceutical ingredient (API) or Hycon finished formulations upon request. The Hycon suppliers may include Hycon API manufacturers, exporters, distributors and traders.
click here to find a list of Hycon suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Hycon DMF (Drug Master File) is a document detailing the whole manufacturing process of Hycon active pharmaceutical ingredient (API) in detail. Different forms of Hycon DMFs exist exist since differing nations have different regulations, such as Hycon USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hycon DMF submitted to regulatory agencies in the US is known as a USDMF. Hycon USDMF includes data on Hycon's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hycon USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hycon 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 Hycon Drug Master File in Korea (Hycon KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Hycon. The MFDS reviews the Hycon KDMF as part of the drug registration process and uses the information provided in the Hycon KDMF to evaluate the safety and efficacy of the drug.
After submitting a Hycon 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 Hycon API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Hycon 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 Hycon as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Hycon 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 Hycon 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 Hycon and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Hycon NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Hycon suppliers with NDC on PharmaCompass.
Hycon 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 Hycon 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 Hycon GMP manufacturer or Hycon GMP API supplier for your needs.
A Hycon CoA (Certificate of Analysis) is a formal document that attests to Hycon's compliance with Hycon specifications and serves as a tool for batch-level quality control.
Hycon CoA mostly includes findings from lab analyses of a specific batch. For each Hycon 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.
Hycon may be tested according to a variety of international standards, such as European Pharmacopoeia (Hycon EP), Hycon JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Hycon USP).
