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API SUPPLIERS
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Delivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.
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Symbiotica delivers high-quality APIs through advanced R&D, GMP-certified manufacturing, & trusted global pharmaceutical partnerships.
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Flavoxate Hydrochloride BP/USP
Date of Issue : 2025-08-05
Valid Till : 2028-06-25
Written Confirmation Number : WC-0054
Address of the Firm : Block No. 82/B, ECP Road, At & Post Karakhadi, Tal - Padra, Dist. Baroda, Gujara...
Symbiotica delivers high-quality APIs through advanced R&D, GMP-certified manufacturing, & trusted global pharmaceutical partnerships.
Date of Issue : 2025-05-20
Valid Till : 2028-05-22
Written Confirmation Number : 3923/25
Address of the Firm : No. 518, Jalan Waja 4, Taman Industri Waja, 09000 Kulim, Kedah, Malaysia
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Flavoxate 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 Flavoxate manufacturer or Flavoxate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Flavoxate manufacturer or Flavoxate supplier.
PharmaCompass also assists you with knowing the Flavoxate API Price utilized in the formulation of products. Flavoxate API Price is not always fixed or binding as the Flavoxate Price is obtained through a variety of data sources. The Flavoxate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Urispas manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Urispas, including repackagers and relabelers. The FDA regulates Urispas manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Urispas 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 Urispas manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Urispas supplier is an individual or a company that provides Urispas active pharmaceutical ingredient (API) or Urispas finished formulations upon request. The Urispas suppliers may include Urispas API manufacturers, exporters, distributors and traders.
click here to find a list of Urispas suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Urispas DMF (Drug Master File) is a document detailing the whole manufacturing process of Urispas active pharmaceutical ingredient (API) in detail. Different forms of Urispas DMFs exist exist since differing nations have different regulations, such as Urispas USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Urispas DMF submitted to regulatory agencies in the US is known as a USDMF. Urispas USDMF includes data on Urispas's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Urispas USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Urispas 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 Urispas Drug Master File in Japan (Urispas JDMF) empowers Urispas 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 Urispas JDMF during the approval evaluation for pharmaceutical products. At the time of Urispas 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 Urispas 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 Urispas Drug Master File in Korea (Urispas KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Urispas. The MFDS reviews the Urispas KDMF as part of the drug registration process and uses the information provided in the Urispas KDMF to evaluate the safety and efficacy of the drug.
After submitting a Urispas 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 Urispas API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Urispas suppliers with KDMF on PharmaCompass.
A Urispas written confirmation (Urispas WC) is an official document issued by a regulatory agency to a Urispas manufacturer, verifying that the manufacturing facility of a Urispas active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Urispas APIs or Urispas finished pharmaceutical products to another nation, regulatory agencies frequently require a Urispas WC (written confirmation) as part of the regulatory process.
click here to find a list of Urispas 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 Urispas as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Urispas 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 Urispas 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 Urispas and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Urispas NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Urispas suppliers with NDC on PharmaCompass.
Urispas 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 Urispas 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 Urispas GMP manufacturer or Urispas GMP API supplier for your needs.
A Urispas CoA (Certificate of Analysis) is a formal document that attests to Urispas's compliance with Urispas specifications and serves as a tool for batch-level quality control.
Urispas CoA mostly includes findings from lab analyses of a specific batch. For each Urispas 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.
Urispas may be tested according to a variety of international standards, such as European Pharmacopoeia (Urispas EP), Urispas JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Urispas USP).
