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Drugs in Development
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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**Fede...DOSAGE - INJECTABLE;INJECTION - 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**Fede...DOSAGE - INJECTABLE;INJECTION - 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**Fed...DOSAGE - INJECTABLE;INJECTION - 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
A Morphine Sulfate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Morphine Sulfate, including repackagers and relabelers. The FDA regulates Morphine Sulfate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Morphine Sulfate 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 Morphine Sulfate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Morphine Sulfate supplier is an individual or a company that provides Morphine Sulfate active pharmaceutical ingredient (API) or Morphine Sulfate finished formulations upon request. The Morphine Sulfate suppliers may include Morphine Sulfate API manufacturers, exporters, distributors and traders.
click here to find a list of Morphine Sulfate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Morphine Sulfate DMF (Drug Master File) is a document detailing the whole manufacturing process of Morphine Sulfate active pharmaceutical ingredient (API) in detail. Different forms of Morphine Sulfate DMFs exist exist since differing nations have different regulations, such as Morphine Sulfate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Morphine Sulfate DMF submitted to regulatory agencies in the US is known as a USDMF. Morphine Sulfate USDMF includes data on Morphine Sulfate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Morphine Sulfate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Morphine Sulfate 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 Morphine Sulfate Drug Master File in Korea (Morphine Sulfate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Morphine Sulfate. The MFDS reviews the Morphine Sulfate KDMF as part of the drug registration process and uses the information provided in the Morphine Sulfate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Morphine Sulfate 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 Morphine Sulfate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Morphine Sulfate suppliers with KDMF on PharmaCompass.
A Morphine Sulfate CEP of the European Pharmacopoeia monograph is often referred to as a Morphine Sulfate Certificate of Suitability (COS). The purpose of a Morphine Sulfate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Morphine Sulfate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Morphine Sulfate to their clients by showing that a Morphine Sulfate CEP has been issued for it. The manufacturer submits a Morphine Sulfate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Morphine Sulfate CEP holder for the record. Additionally, the data presented in the Morphine Sulfate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Morphine Sulfate DMF.
A Morphine Sulfate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Morphine Sulfate 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 Morphine Sulfate 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 Morphine Sulfate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Morphine Sulfate 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 Morphine Sulfate 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 Morphine Sulfate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Morphine Sulfate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Morphine Sulfate suppliers with NDC on PharmaCompass.
Morphine Sulfate 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 Morphine Sulfate 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 Morphine Sulfate GMP manufacturer or Morphine Sulfate GMP API supplier for your needs.
A Morphine Sulfate CoA (Certificate of Analysis) is a formal document that attests to Morphine Sulfate's compliance with Morphine Sulfate specifications and serves as a tool for batch-level quality control.
Morphine Sulfate CoA mostly includes findings from lab analyses of a specific batch. For each Morphine Sulfate 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.
Morphine Sulfate may be tested according to a variety of international standards, such as European Pharmacopoeia (Morphine Sulfate EP), Morphine Sulfate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Morphine Sulfate USP).
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