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JDMF
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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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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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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 Hydrocodone Bitartrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hydrocodone Bitartrate, including repackagers and relabelers. The FDA regulates Hydrocodone Bitartrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hydrocodone Bitartrate 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 Bitartrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hydrocodone Bitartrate supplier is an individual or a company that provides Hydrocodone Bitartrate active pharmaceutical ingredient (API) or Hydrocodone Bitartrate finished formulations upon request. The Hydrocodone Bitartrate suppliers may include Hydrocodone Bitartrate API manufacturers, exporters, distributors and traders.
click here to find a list of Hydrocodone Bitartrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Hydrocodone Bitartrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Hydrocodone Bitartrate active pharmaceutical ingredient (API) in detail. Different forms of Hydrocodone Bitartrate DMFs exist exist since differing nations have different regulations, such as Hydrocodone Bitartrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hydrocodone Bitartrate DMF submitted to regulatory agencies in the US is known as a USDMF. Hydrocodone Bitartrate USDMF includes data on Hydrocodone Bitartrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hydrocodone Bitartrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hydrocodone Bitartrate 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 Bitartrate Drug Master File in Korea (Hydrocodone Bitartrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Hydrocodone Bitartrate. The MFDS reviews the Hydrocodone Bitartrate KDMF as part of the drug registration process and uses the information provided in the Hydrocodone Bitartrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Hydrocodone Bitartrate 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 Bitartrate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Hydrocodone Bitartrate 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 Bitartrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Hydrocodone Bitartrate 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 Bitartrate 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 Bitartrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Hydrocodone Bitartrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Hydrocodone Bitartrate suppliers with NDC on PharmaCompass.
Hydrocodone Bitartrate 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 Bitartrate 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 Bitartrate GMP manufacturer or Hydrocodone Bitartrate GMP API supplier for your needs.
A Hydrocodone Bitartrate CoA (Certificate of Analysis) is a formal document that attests to Hydrocodone Bitartrate's compliance with Hydrocodone Bitartrate specifications and serves as a tool for batch-level quality control.
Hydrocodone Bitartrate CoA mostly includes findings from lab analyses of a specific batch. For each Hydrocodone Bitartrate 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 Bitartrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Hydrocodone Bitartrate EP), Hydrocodone Bitartrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Hydrocodone Bitartrate USP).
