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Find Darifenacin Hydrobromide manufacturers, exporters & distributors on PharmaCompass

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  • TABLET, EXTENDED RELEASE;ORAL - EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, EXTENDED RELEASE;ORAL - EQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Looking for 133099-07-7 / Darifenacin Hydrobromide API manufacturers, exporters & distributors?

Darifenacin Hydrobromide manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Darifenacin Hydrobromide 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 Darifenacin Hydrobromide manufacturer or Darifenacin Hydrobromide supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Darifenacin Hydrobromide manufacturer or Darifenacin Hydrobromide supplier.

PharmaCompass also assists you with knowing the Darifenacin Hydrobromide API Price utilized in the formulation of products. Darifenacin Hydrobromide API Price is not always fixed or binding as the Darifenacin Hydrobromide Price is obtained through a variety of data sources. The Darifenacin Hydrobromide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Darifenacin Hydrobromide

Synonyms

Darifenacin hbr, 133099-07-7, Emselex, Darifenacin (hydrobromide), Darifenacin hydrobromide [usan], Cr02eyq8gv

Cas Number

133099-07-7

Unique Ingredient Identifier (UNII)

CR02EYQ8GV

Darifenacin Manufacturers

A Darifenacin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Darifenacin, including repackagers and relabelers. The FDA regulates Darifenacin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Darifenacin 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 Darifenacin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Darifenacin Suppliers

A Darifenacin supplier is an individual or a company that provides Darifenacin active pharmaceutical ingredient (API) or Darifenacin finished formulations upon request. The Darifenacin suppliers may include Darifenacin API manufacturers, exporters, distributors and traders.

click here to find a list of Darifenacin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Darifenacin USDMF

A Darifenacin DMF (Drug Master File) is a document detailing the whole manufacturing process of Darifenacin active pharmaceutical ingredient (API) in detail. Different forms of Darifenacin DMFs exist exist since differing nations have different regulations, such as Darifenacin USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Darifenacin DMF submitted to regulatory agencies in the US is known as a USDMF. Darifenacin USDMF includes data on Darifenacin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Darifenacin USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Darifenacin suppliers with USDMF on PharmaCompass.

Darifenacin WC

A Darifenacin written confirmation (Darifenacin WC) is an official document issued by a regulatory agency to a Darifenacin manufacturer, verifying that the manufacturing facility of a Darifenacin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Darifenacin APIs or Darifenacin finished pharmaceutical products to another nation, regulatory agencies frequently require a Darifenacin WC (written confirmation) as part of the regulatory process.

click here to find a list of Darifenacin suppliers with Written Confirmation (WC) on PharmaCompass.

Darifenacin NDC

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 Darifenacin as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Darifenacin API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Darifenacin 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Darifenacin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Darifenacin NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Darifenacin suppliers with NDC on PharmaCompass.

Darifenacin GMP

Darifenacin 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 Darifenacin 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 Darifenacin GMP manufacturer or Darifenacin GMP API supplier for your needs.

Darifenacin CoA

A Darifenacin CoA (Certificate of Analysis) is a formal document that attests to Darifenacin's compliance with Darifenacin specifications and serves as a tool for batch-level quality control.

Darifenacin CoA mostly includes findings from lab analyses of a specific batch. For each Darifenacin 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.

Darifenacin may be tested according to a variety of international standards, such as European Pharmacopoeia (Darifenacin EP), Darifenacin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Darifenacin USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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