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API SUPPLIERS
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USDMF
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : Complete
Rev. Date : 2022-08-05
Pay. Date : 2022-08-03
DMF Number : 22245
Submission : 2008-12-01
Status :
Type : II
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Veranova: A CDMO that manages complexity with confidence.
About the Company : Veranova is a global leader in the development and manufacturing of specialist and complex APIs for pharma and biotech customers. We have over 50 years of experience navigating the...
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Drugs in Development
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Methamphetamine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Methamphetamine Hydrochloride, including repackagers and relabelers. The FDA regulates Methamphetamine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Methamphetamine Hydrochloride 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 Methamphetamine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Methamphetamine Hydrochloride supplier is an individual or a company that provides Methamphetamine Hydrochloride active pharmaceutical ingredient (API) or Methamphetamine Hydrochloride finished formulations upon request. The Methamphetamine Hydrochloride suppliers may include Methamphetamine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Methamphetamine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Methamphetamine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Methamphetamine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Methamphetamine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Methamphetamine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Methamphetamine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Methamphetamine Hydrochloride USDMF includes data on Methamphetamine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Methamphetamine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Methamphetamine Hydrochloride suppliers with USDMF 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 Methamphetamine Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Methamphetamine Hydrochloride 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 Methamphetamine Hydrochloride 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 Methamphetamine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Methamphetamine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Methamphetamine Hydrochloride suppliers with NDC on PharmaCompass.
Methamphetamine Hydrochloride 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 Methamphetamine Hydrochloride 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 Methamphetamine Hydrochloride GMP manufacturer or Methamphetamine Hydrochloride GMP API supplier for your needs.
A Methamphetamine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Methamphetamine Hydrochloride's compliance with Methamphetamine Hydrochloride specifications and serves as a tool for batch-level quality control.
Methamphetamine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Methamphetamine Hydrochloride 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.
Methamphetamine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Methamphetamine Hydrochloride EP), Methamphetamine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Methamphetamine Hydrochloride USP).
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