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Synnat Pharma is one of the leading active pharmaceutical ingredients and intermediates manufacturers.
Papaverine hydrochloride BP/EP/USP
Date of Issue : 2021-06-03
Valid Till : 2024-02-07
Written Confirmation Number : WC-301n
Address of the Firm : Plot No 60A, Jawaharlal Nehru Pharma City, Parawada Mandal, Vishakhapatnam, Andh...
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Synnat Pharma is one of the leading active pharmaceutical ingredients and intermediates manufacturers.
About the Company : Synnat Pharma is a fast-growing pharmaceutical company dedicated to the identification, development, production and distribution of potent phytochemicals and botanical extracts. AP...
Temad- We think of world-class quality.
About the Company : Established in 1997, Temad Co. is one of the largest producers of APIs in Iran & an innovative manufacturer of narcotic and non-narcotic products of world-class quality in the Midd...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
About the Company : DKSH, founded with the goal of improving people's lives, assists businesses with market expansion and business growth in both existing and emerging markets. It has been fostering g...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
About the Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs)...
Parand Darou is a knowledge-based company, focused on the production of Narcotic APIs.
About the Company : Parand Daro Pharmaceutical Company is a knowledge-based company that commenced operations in 2015, focusing on the production of narcotic medicinal substances. Parand Daro holds th...
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ABOUT THIS PAGE
A Papaverine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Papaverine, including repackagers and relabelers. The FDA regulates Papaverine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Papaverine 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 Papaverine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Papaverine supplier is an individual or a company that provides Papaverine active pharmaceutical ingredient (API) or Papaverine finished formulations upon request. The Papaverine suppliers may include Papaverine API manufacturers, exporters, distributors and traders.
click here to find a list of Papaverine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Papaverine DMF (Drug Master File) is a document detailing the whole manufacturing process of Papaverine active pharmaceutical ingredient (API) in detail. Different forms of Papaverine DMFs exist exist since differing nations have different regulations, such as Papaverine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Papaverine DMF submitted to regulatory agencies in the US is known as a USDMF. Papaverine USDMF includes data on Papaverine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Papaverine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Papaverine 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 Papaverine Drug Master File in Japan (Papaverine JDMF) empowers Papaverine 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 Papaverine JDMF during the approval evaluation for pharmaceutical products. At the time of Papaverine 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 Papaverine suppliers with JDMF on PharmaCompass.
A Papaverine written confirmation (Papaverine WC) is an official document issued by a regulatory agency to a Papaverine manufacturer, verifying that the manufacturing facility of a Papaverine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Papaverine APIs or Papaverine finished pharmaceutical products to another nation, regulatory agencies frequently require a Papaverine WC (written confirmation) as part of the regulatory process.
click here to find a list of Papaverine 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 Papaverine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Papaverine 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 Papaverine 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 Papaverine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Papaverine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Papaverine suppliers with NDC on PharmaCompass.
Papaverine 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 Papaverine 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 Papaverine GMP manufacturer or Papaverine GMP API supplier for your needs.
A Papaverine CoA (Certificate of Analysis) is a formal document that attests to Papaverine's compliance with Papaverine specifications and serves as a tool for batch-level quality control.
Papaverine CoA mostly includes findings from lab analyses of a specific batch. For each Papaverine 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.
Papaverine may be tested according to a variety of international standards, such as European Pharmacopoeia (Papaverine EP), Papaverine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Papaverine USP).
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