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KDMF
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Australia
DRUG PRODUCT COMPOSITIONS0
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
Aspen API. More than just an API™
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
Aspen API. More than just an API™
About the Company : Aspen API is a cooperative entity formed by Aspen Oss in the Netherlands and Fine Chemicals Corporation in South Africa. The company supplies a broad portfolio of over 50 high-qual...
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
About the Company : Transo-Pharm is a licensed distributor of pharmaceutical components for human and veterinary markets. The company supports the full API life cycle, from development to sales, and a...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Rochem, established in 1994, is a global distributor of pharmaceutical, food, nutritional, and animal health ingredients, sourcing high-quality products from China. Headquartered i...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
Lead Product(s) : Oxytocin,Inapplicable
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Monash University
Deal Size : Undisclosed
Deal Type : Agreement
Details : Vectura will support the development of a single use device/formulation combination for evaluation in Phase I of inhaled oxytocin, and then expedite technical transfer to a commercial manufacturer to advance to Phase III and commercial launch.
Product Name : Undisclosed
Product Type : Hormone
Upfront Cash : Undisclosed
September 14, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
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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 - INJECTABLE;INJECTION - 100USP UNITS/...DOSAGE - INJECTABLE;INJECTION - 100USP UNITS/10ML (10USP UNITS/ML)
USFDA APPLICATION NUMBER - 18248
DOSAGE - INJECTABLE;INJECTION - 10USP UNITS/M...DOSAGE - INJECTABLE;INJECTION - 10USP UNITS/ML (10USP UNITS/ML)
USFDA APPLICATION NUMBER - 18248
DOSAGE - INJECTABLE;INJECTION - 300USP UNITS/...DOSAGE - INJECTABLE;INJECTION - 300USP UNITS/30ML (10USP UNITS/ML)
USFDA APPLICATION NUMBER - 18248
DOSAGE - INJECTABLE;INJECTION - 100USP UNITS/...DOSAGE - INJECTABLE;INJECTION - 100USP UNITS/10ML (10USP UNITS/ML)
USFDA APPLICATION NUMBER - 18261
DOSAGE - INJECTABLE;INJECTION - 10USP UNITS/M...DOSAGE - INJECTABLE;INJECTION - 10USP UNITS/ML (10USP UNITS/ML)
USFDA APPLICATION NUMBER - 18261
DOSAGE - INJECTABLE;INJECTION - 500USP UNITS/...DOSAGE - INJECTABLE;INJECTION - 500USP UNITS/50ML (10USP UNITS/ML)
USFDA APPLICATION NUMBER - 18261
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ABOUT THIS PAGE
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PharmaCompass offers a list of Oxytocin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Oxytocin manufacturer or Oxytocin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Oxytocin manufacturer or Oxytocin supplier.
A Orasthin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Orasthin, including repackagers and relabelers. The FDA regulates Orasthin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Orasthin 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 Orasthin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Orasthin supplier is an individual or a company that provides Orasthin active pharmaceutical ingredient (API) or Orasthin finished formulations upon request. The Orasthin suppliers may include Orasthin API manufacturers, exporters, distributors and traders.
click here to find a list of Orasthin suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Orasthin DMF (Drug Master File) is a document detailing the whole manufacturing process of Orasthin active pharmaceutical ingredient (API) in detail. Different forms of Orasthin DMFs exist exist since differing nations have different regulations, such as Orasthin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Orasthin DMF submitted to regulatory agencies in the US is known as a USDMF. Orasthin USDMF includes data on Orasthin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Orasthin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Orasthin suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Orasthin Drug Master File in Japan (Orasthin JDMF) empowers Orasthin API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Orasthin JDMF during the approval evaluation for pharmaceutical products. At the time of Orasthin JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Orasthin suppliers with JDMF on PharmaCompass.
A Orasthin CEP of the European Pharmacopoeia monograph is often referred to as a Orasthin Certificate of Suitability (COS). The purpose of a Orasthin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Orasthin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Orasthin to their clients by showing that a Orasthin CEP has been issued for it. The manufacturer submits a Orasthin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Orasthin CEP holder for the record. Additionally, the data presented in the Orasthin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Orasthin DMF.
A Orasthin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Orasthin 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 Orasthin suppliers with CEP (COS) on PharmaCompass.
A Orasthin written confirmation (Orasthin WC) is an official document issued by a regulatory agency to a Orasthin manufacturer, verifying that the manufacturing facility of a Orasthin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Orasthin APIs or Orasthin finished pharmaceutical products to another nation, regulatory agencies frequently require a Orasthin WC (written confirmation) as part of the regulatory process.
click here to find a list of Orasthin suppliers with Written Confirmation (WC) 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 Orasthin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Orasthin 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 Orasthin 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 Orasthin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Orasthin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Orasthin suppliers with NDC on PharmaCompass.
Orasthin 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 Orasthin GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Orasthin GMP manufacturer or Orasthin GMP API supplier for your needs.
A Orasthin CoA (Certificate of Analysis) is a formal document that attests to Orasthin's compliance with Orasthin specifications and serves as a tool for batch-level quality control.
Orasthin CoA mostly includes findings from lab analyses of a specific batch. For each Orasthin 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.
Orasthin may be tested according to a variety of international standards, such as European Pharmacopoeia (Orasthin EP), Orasthin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Orasthin USP).
