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API SUPPLIERS
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USDMF
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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
About the Company : Transo-Pharm, founded in 1987, is a fully licensed global distributor of pharmaceutical components for health and veterinary industries. It supports customers throughout the API li...
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 ...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
About the Company : Inabata France, established in 1990 and part of the Inabata Group, acquired Pharmasynthèse in 2006. Today, Inabata-Pharmasynthèse offers sourcing, manufacturing, and development ...
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...
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
About the Company : Malladi Drugs & Pharmaceuticals Ltd, founded in 1980 by Mr. M L N Sastry, is a leader in manufacturing ephedrine and pseudoephedrine salts. It is now the top API manufacturer in th...
AMI Lifesciences is Driven by Chemistry. Powered by People.
About the Company : Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory thera...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...
Lifecare Labs has been developing innovative products in specialist areas of medicine.
About the Company : Lifecare Labs manufactures bulk drugs (APIs) and intermediates in line with stringent quality standards. The company focuses on delivering cost-effective solutions while meeting cu...
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) : Tranexamic Acid,Levonorgestrel
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Tranexamic Acid is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Uterine Hemorrhage.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 14, 2011
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Apex Healthcare Limited: ISO 9001:2008, WHO-GMP, US FDA-audited manufacturer & exporter of APIs, bulk drugs, and formulations.
CAS Number : 56-91-7
End Use API : Tranexamic Acid
About The Company : Apex Healthcare Limited, established in 2002 in Ankleshwar, India, is a trusted manufacturer and exporter of APIs, bulk drugs, and formulations. Its US FDA-audi...
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DOSAGE - INJECTABLE;INJECTION - 100MG/ML
USFDA APPLICATION NUMBER - 19281
DOSAGE - TABLET;ORAL - 650MG
USFDA APPLICATION NUMBER - 22430
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Tranexamic Acid 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 Tranexamic Acid manufacturer or Tranexamic Acid supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tranexamic Acid manufacturer or Tranexamic Acid supplier.
A 08455_FLUKA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 08455_FLUKA, including repackagers and relabelers. The FDA regulates 08455_FLUKA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 08455_FLUKA 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 08455_FLUKA manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A 08455_FLUKA supplier is an individual or a company that provides 08455_FLUKA active pharmaceutical ingredient (API) or 08455_FLUKA finished formulations upon request. The 08455_FLUKA suppliers may include 08455_FLUKA API manufacturers, exporters, distributors and traders.
click here to find a list of 08455_FLUKA suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A 08455_FLUKA DMF (Drug Master File) is a document detailing the whole manufacturing process of 08455_FLUKA active pharmaceutical ingredient (API) in detail. Different forms of 08455_FLUKA DMFs exist exist since differing nations have different regulations, such as 08455_FLUKA USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 08455_FLUKA DMF submitted to regulatory agencies in the US is known as a USDMF. 08455_FLUKA USDMF includes data on 08455_FLUKA's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 08455_FLUKA USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 08455_FLUKA 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 08455_FLUKA Drug Master File in Japan (08455_FLUKA JDMF) empowers 08455_FLUKA 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 08455_FLUKA JDMF during the approval evaluation for pharmaceutical products. At the time of 08455_FLUKA 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 08455_FLUKA suppliers with JDMF 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 08455_FLUKA Drug Master File in Korea (08455_FLUKA KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 08455_FLUKA. The MFDS reviews the 08455_FLUKA KDMF as part of the drug registration process and uses the information provided in the 08455_FLUKA KDMF to evaluate the safety and efficacy of the drug.
After submitting a 08455_FLUKA 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 08455_FLUKA API can apply through the Korea Drug Master File (KDMF).
click here to find a list of 08455_FLUKA suppliers with KDMF on PharmaCompass.
A 08455_FLUKA CEP of the European Pharmacopoeia monograph is often referred to as a 08455_FLUKA Certificate of Suitability (COS). The purpose of a 08455_FLUKA CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 08455_FLUKA EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 08455_FLUKA to their clients by showing that a 08455_FLUKA CEP has been issued for it. The manufacturer submits a 08455_FLUKA CEP (COS) as part of the market authorization procedure, and it takes on the role of a 08455_FLUKA CEP holder for the record. Additionally, the data presented in the 08455_FLUKA CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 08455_FLUKA DMF.
A 08455_FLUKA CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 08455_FLUKA 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 08455_FLUKA suppliers with CEP (COS) on PharmaCompass.
A 08455_FLUKA written confirmation (08455_FLUKA WC) is an official document issued by a regulatory agency to a 08455_FLUKA manufacturer, verifying that the manufacturing facility of a 08455_FLUKA active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 08455_FLUKA APIs or 08455_FLUKA finished pharmaceutical products to another nation, regulatory agencies frequently require a 08455_FLUKA WC (written confirmation) as part of the regulatory process.
click here to find a list of 08455_FLUKA 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 08455_FLUKA as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 08455_FLUKA 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 08455_FLUKA 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 08455_FLUKA and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 08455_FLUKA NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of 08455_FLUKA suppliers with NDC on PharmaCompass.
08455_FLUKA 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 08455_FLUKA GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right 08455_FLUKA GMP manufacturer or 08455_FLUKA GMP API supplier for your needs.
A 08455_FLUKA CoA (Certificate of Analysis) is a formal document that attests to 08455_FLUKA's compliance with 08455_FLUKA specifications and serves as a tool for batch-level quality control.
08455_FLUKA CoA mostly includes findings from lab analyses of a specific batch. For each 08455_FLUKA 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.
08455_FLUKA may be tested according to a variety of international standards, such as European Pharmacopoeia (08455_FLUKA EP), 08455_FLUKA JP (Japanese Pharmacopeia) and the US Pharmacopoeia (08455_FLUKA USP).
