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API SUPPLIERS
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USDMF
Evonik Health Care is the innovation hub for leading life science companies
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35044
Submission : 2020-08-19
Status :
Type : II
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Anlon Healthcare manufactures high-quality Pharmaceutical Bulk Drugs & Intermediates compliant with FDA, PMDA, KFDA, cGMP & WHO-GMP.
About the Company : Anlon Healthcare is a research-focused pharmaceutical manufacturer based in Rajkot, specializing in bulk drugs and intermediates. The company’s products comply with international...
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PharmaCompass offers a list of L-Ornithine L-aspartate 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 L-Ornithine L-aspartate manufacturer or L-Ornithine L-aspartate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred L-Ornithine L-aspartate manufacturer or L-Ornithine L-aspartate supplier.
A L-Ornithine L-aspartate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-Ornithine L-aspartate, including repackagers and relabelers. The FDA regulates L-Ornithine L-aspartate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-Ornithine L-aspartate 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 L-Ornithine L-aspartate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A L-Ornithine L-aspartate supplier is an individual or a company that provides L-Ornithine L-aspartate active pharmaceutical ingredient (API) or L-Ornithine L-aspartate finished formulations upon request. The L-Ornithine L-aspartate suppliers may include L-Ornithine L-aspartate API manufacturers, exporters, distributors and traders.
click here to find a list of L-Ornithine L-aspartate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A L-Ornithine L-aspartate DMF (Drug Master File) is a document detailing the whole manufacturing process of L-Ornithine L-aspartate active pharmaceutical ingredient (API) in detail. Different forms of L-Ornithine L-aspartate DMFs exist exist since differing nations have different regulations, such as L-Ornithine L-aspartate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A L-Ornithine L-aspartate DMF submitted to regulatory agencies in the US is known as a USDMF. L-Ornithine L-aspartate USDMF includes data on L-Ornithine L-aspartate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The L-Ornithine L-aspartate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of L-Ornithine L-aspartate suppliers with USDMF on PharmaCompass.
L-Ornithine L-aspartate 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 L-Ornithine L-aspartate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right L-Ornithine L-aspartate GMP manufacturer or L-Ornithine L-aspartate GMP API supplier for your needs.
A L-Ornithine L-aspartate CoA (Certificate of Analysis) is a formal document that attests to L-Ornithine L-aspartate's compliance with L-Ornithine L-aspartate specifications and serves as a tool for batch-level quality control.
L-Ornithine L-aspartate CoA mostly includes findings from lab analyses of a specific batch. For each L-Ornithine L-aspartate 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.
L-Ornithine L-aspartate may be tested according to a variety of international standards, such as European Pharmacopoeia (L-Ornithine L-aspartate EP), L-Ornithine L-aspartate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (L-Ornithine L-aspartate USP).
