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Synnat Pharma is one of the leading active pharmaceutical ingredients and intermediates manufacturers.
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Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Papaverine 60
Dosage Form : INJ
Dosage Strength : 60mg/2 ml
Packaging : 2X5mg/2 ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
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PharmaCompass offers a list of Papaverine Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Papaverine Hydrochloride manufacturer or Papaverine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Papaverine Hydrochloride manufacturer or Papaverine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Papaverine Hydrochloride API Price utilized in the formulation of products. Papaverine Hydrochloride API Price is not always fixed or binding as the Papaverine Hydrochloride Price is obtained through a variety of data sources. The Papaverine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Pavased manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pavased, including repackagers and relabelers. The FDA regulates Pavased manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pavased 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 Pavased manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pavased supplier is an individual or a company that provides Pavased active pharmaceutical ingredient (API) or Pavased finished formulations upon request. The Pavased suppliers may include Pavased API manufacturers, exporters, distributors and traders.
click here to find a list of Pavased suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pavased DMF (Drug Master File) is a document detailing the whole manufacturing process of Pavased active pharmaceutical ingredient (API) in detail. Different forms of Pavased DMFs exist exist since differing nations have different regulations, such as Pavased USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pavased DMF submitted to regulatory agencies in the US is known as a USDMF. Pavased USDMF includes data on Pavased's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pavased USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pavased 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 Pavased Drug Master File in Japan (Pavased JDMF) empowers Pavased 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 Pavased JDMF during the approval evaluation for pharmaceutical products. At the time of Pavased 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 Pavased 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 Pavased Drug Master File in Korea (Pavased KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Pavased. The MFDS reviews the Pavased KDMF as part of the drug registration process and uses the information provided in the Pavased KDMF to evaluate the safety and efficacy of the drug.
After submitting a Pavased 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 Pavased API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Pavased suppliers with KDMF on PharmaCompass.
A Pavased written confirmation (Pavased WC) is an official document issued by a regulatory agency to a Pavased manufacturer, verifying that the manufacturing facility of a Pavased active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Pavased APIs or Pavased finished pharmaceutical products to another nation, regulatory agencies frequently require a Pavased WC (written confirmation) as part of the regulatory process.
click here to find a list of Pavased 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 Pavased as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Pavased 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 Pavased 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 Pavased and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pavased NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Pavased suppliers with NDC on PharmaCompass.
Pavased 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 Pavased 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 Pavased GMP manufacturer or Pavased GMP API supplier for your needs.
A Pavased CoA (Certificate of Analysis) is a formal document that attests to Pavased's compliance with Pavased specifications and serves as a tool for batch-level quality control.
Pavased CoA mostly includes findings from lab analyses of a specific batch. For each Pavased 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.
Pavased may be tested according to a variety of international standards, such as European Pharmacopoeia (Pavased EP), Pavased JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pavased USP).
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