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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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Ethypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.
Regulatory Info :
Registration Country : Italy
Brand Name : TWICE
Dosage Form : Extended Release Hard Capsules
Dosage Strength : 10 mg
Packaging : 16 UNITS 10 MG - ORAL USE EXTENDED RELEASE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Ethypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.
Regulatory Info :
Registration Country : Italy
Brand Name : TWICE
Dosage Form : Extended Release Hard Capsules
Dosage Strength : 100 mg
Packaging : 16 UNITS 100 MG - ORAL USE EXTENDED RELEASE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Ethypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.
Regulatory Info :
Registration Country : Italy
Brand Name : TWICE
Dosage Form : Extended Release Hard Capsules
Dosage Strength : 30 mg
Packaging : 16 UNITS 30 MG - ORAL USE PROLONGED RELEASE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Ethypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.
Regulatory Info :
Registration Country : Italy
Brand Name : TWICE
Dosage Form : Extended Release Hard Capsules
Dosage Strength : 60 mg
Packaging : 16 UNITS 60 MG - ORAL USE PROLONGED RELEASE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 100M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 100MG
USFDA APPLICATION NUMBER - 19516
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 15MG
USFDA APPLICATION NUMBER - 19516
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 200M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 200MG
USFDA APPLICATION NUMBER - 19516
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 30MG
USFDA APPLICATION NUMBER - 19516
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 60MG
USFDA APPLICATION NUMBER - 19516
DOSAGE - INJECTABLE;INJECTION - 1MG/ML **Fede...DOSAGE - INJECTABLE;INJECTION - 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19916
DOSAGE - INJECTABLE;INJECTION - 5MG/ML **Fede...DOSAGE - INJECTABLE;INJECTION - 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19916
DOSAGE - SOLUTION;INTRAMUSCULAR - 10MG/0.7ML ...DOSAGE - SOLUTION;INTRAMUSCULAR - 10MG/0.7ML (10MG/0.7ML)
USFDA APPLICATION NUMBER - 19999
DOSAGE - INJECTABLE;INJECTION - 10MG/ML
USFDA APPLICATION NUMBER - 202515
DOSAGE - INJECTABLE;INJECTION - 15MG/ML **Fed...DOSAGE - INJECTABLE;INJECTION - 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 202515
DOSAGE - INJECTABLE;INJECTION - 2MG/ML
USFDA APPLICATION NUMBER - 202515
DOSAGE - INJECTABLE;INJECTION - 4MG/ML
USFDA APPLICATION NUMBER - 202515
DOSAGE - INJECTABLE;INJECTION - 50MG/ML
USFDA APPLICATION NUMBER - 202515
DOSAGE - INJECTABLE;INJECTION - 8MG/ML
USFDA APPLICATION NUMBER - 202515
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 100...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 100MG
USFDA APPLICATION NUMBER - 20616
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 10M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 10MG
USFDA APPLICATION NUMBER - 20616
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 130...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 130MG
USFDA APPLICATION NUMBER - 20616
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 150...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 150MG
USFDA APPLICATION NUMBER - 20616
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 200...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 200MG
USFDA APPLICATION NUMBER - 20616
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 20M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 20MG
USFDA APPLICATION NUMBER - 20616
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 30M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 30MG
USFDA APPLICATION NUMBER - 20616
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 40M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 40MG
USFDA APPLICATION NUMBER - 20616
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 50M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 50MG
USFDA APPLICATION NUMBER - 20616
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 60M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 60MG
USFDA APPLICATION NUMBER - 20616
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 70M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 70MG
USFDA APPLICATION NUMBER - 20616
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 80M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 80MG
USFDA APPLICATION NUMBER - 20616
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 100M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 100MG
USFDA APPLICATION NUMBER - 206544
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 15MG
USFDA APPLICATION NUMBER - 206544
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 30MG
USFDA APPLICATION NUMBER - 206544
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 60MG
USFDA APPLICATION NUMBER - 206544
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 15MG
USFDA APPLICATION NUMBER - 208603
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 30MG
USFDA APPLICATION NUMBER - 208603
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 60MG
USFDA APPLICATION NUMBER - 208603
DOSAGE - SOLUTION;ORAL - 100MG/5ML
USFDA APPLICATION NUMBER - 22195
DOSAGE - SOLUTION;ORAL - 10MG/5ML
USFDA APPLICATION NUMBER - 22195
DOSAGE - SOLUTION;ORAL - 20MG/5ML
USFDA APPLICATION NUMBER - 22195
DOSAGE - TABLET;ORAL - 15MG
USFDA APPLICATION NUMBER - 22207
DOSAGE - TABLET;ORAL - 30MG
USFDA APPLICATION NUMBER - 22207
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 100...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22321
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 20M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22321
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 30M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22321
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 50M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22321
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 60M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22321
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 80M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22321
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ABOUT THIS PAGE
18
PharmaCompass offers a list of Morphine Sulfate 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 Morphine Sulfate manufacturer or Morphine Sulfate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Morphine Sulfate manufacturer or Morphine Sulfate supplier.
PharmaCompass also assists you with knowing the Morphine Sulfate API Price utilized in the formulation of products. Morphine Sulfate API Price is not always fixed or binding as the Morphine Sulfate Price is obtained through a variety of data sources. The Morphine Sulfate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A MORPHABOND ER manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of MORPHABOND ER, including repackagers and relabelers. The FDA regulates MORPHABOND ER manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. MORPHABOND ER 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 MORPHABOND ER manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A MORPHABOND ER supplier is an individual or a company that provides MORPHABOND ER active pharmaceutical ingredient (API) or MORPHABOND ER finished formulations upon request. The MORPHABOND ER suppliers may include MORPHABOND ER API manufacturers, exporters, distributors and traders.
click here to find a list of MORPHABOND ER suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A MORPHABOND ER DMF (Drug Master File) is a document detailing the whole manufacturing process of MORPHABOND ER active pharmaceutical ingredient (API) in detail. Different forms of MORPHABOND ER DMFs exist exist since differing nations have different regulations, such as MORPHABOND ER USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A MORPHABOND ER DMF submitted to regulatory agencies in the US is known as a USDMF. MORPHABOND ER USDMF includes data on MORPHABOND ER's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The MORPHABOND ER USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of MORPHABOND ER 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 MORPHABOND ER Drug Master File in Korea (MORPHABOND ER KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of MORPHABOND ER. The MFDS reviews the MORPHABOND ER KDMF as part of the drug registration process and uses the information provided in the MORPHABOND ER KDMF to evaluate the safety and efficacy of the drug.
After submitting a MORPHABOND ER 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 MORPHABOND ER API can apply through the Korea Drug Master File (KDMF).
click here to find a list of MORPHABOND ER suppliers with KDMF on PharmaCompass.
A MORPHABOND ER CEP of the European Pharmacopoeia monograph is often referred to as a MORPHABOND ER Certificate of Suitability (COS). The purpose of a MORPHABOND ER CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of MORPHABOND ER EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of MORPHABOND ER to their clients by showing that a MORPHABOND ER CEP has been issued for it. The manufacturer submits a MORPHABOND ER CEP (COS) as part of the market authorization procedure, and it takes on the role of a MORPHABOND ER CEP holder for the record. Additionally, the data presented in the MORPHABOND ER CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the MORPHABOND ER DMF.
A MORPHABOND ER CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. MORPHABOND ER 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 MORPHABOND ER suppliers with CEP (COS) 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 MORPHABOND ER as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for MORPHABOND ER 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 MORPHABOND ER 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 MORPHABOND ER and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a MORPHABOND ER NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of MORPHABOND ER suppliers with NDC on PharmaCompass.
MORPHABOND ER 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 MORPHABOND ER 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 MORPHABOND ER GMP manufacturer or MORPHABOND ER GMP API supplier for your needs.
A MORPHABOND ER CoA (Certificate of Analysis) is a formal document that attests to MORPHABOND ER's compliance with MORPHABOND ER specifications and serves as a tool for batch-level quality control.
MORPHABOND ER CoA mostly includes findings from lab analyses of a specific batch. For each MORPHABOND ER 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.
MORPHABOND ER may be tested according to a variety of international standards, such as European Pharmacopoeia (MORPHABOND ER EP), MORPHABOND ER JP (Japanese Pharmacopeia) and the US Pharmacopoeia (MORPHABOND ER USP).
