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Looking for 106463-17-6 / Tamsulosin API manufacturers, exporters & distributors?

Tamsulosin manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Tamsulosin

Synonyms

106463-17-6, Flomax, Tamsulosin hcl, Omnic, Pradif, Harnal

Cas Number

106463-17-6

Unique Ingredient Identifier (UNII)

11SV1951MR

About Tamsulosin

A sulfonamide derivative and adrenergic alpha-1 receptor antagonist that is used to relieve symptoms of urinary obstruction caused by BENIGN PROSTATIC HYPERPLASIA.

Tamsulosin Manufacturers

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

Tamsulosin Suppliers

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

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

Tamsulosin USDMF

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

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

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

Tamsulosin JDMF

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 Tamsulosin Drug Master File in Japan (Tamsulosin JDMF) empowers Tamsulosin 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 Tamsulosin JDMF during the approval evaluation for pharmaceutical products. At the time of Tamsulosin 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 Tamsulosin suppliers with JDMF on PharmaCompass.

Tamsulosin KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Tamsulosin Drug Master File in Korea (Tamsulosin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tamsulosin. The MFDS reviews the Tamsulosin KDMF as part of the drug registration process and uses the information provided in the Tamsulosin KDMF to evaluate the safety and efficacy of the drug.

After submitting a Tamsulosin 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 Tamsulosin API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Tamsulosin suppliers with KDMF on PharmaCompass.

Tamsulosin CEP

A Tamsulosin CEP of the European Pharmacopoeia monograph is often referred to as a Tamsulosin Certificate of Suitability (COS). The purpose of a Tamsulosin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Tamsulosin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Tamsulosin to their clients by showing that a Tamsulosin CEP has been issued for it. The manufacturer submits a Tamsulosin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Tamsulosin CEP holder for the record. Additionally, the data presented in the Tamsulosin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Tamsulosin DMF.

A Tamsulosin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Tamsulosin CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Tamsulosin suppliers with CEP (COS) on PharmaCompass.

Tamsulosin WC

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

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

Tamsulosin 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 Tamsulosin as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Tamsulosin 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 Tamsulosin 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 Tamsulosin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tamsulosin NDC to their finished compounded human drug products, they may choose to do so.

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

Tamsulosin GMP

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

Tamsulosin CoA

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

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

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