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VMF
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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API SUPPLIERS
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USDMF
SWATI - Transforming science into solutions with 60+ years of expertise, global accreditations, and pioneering biotech innovation.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36934
Submission : 2022-03-30
Status :
Type : II
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-23
Pay. Date : 2015-08-27
DMF Number : 28648
Submission : 2014-09-15
Status :
Type : II
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SWATI - Transforming science into solutions with 60+ years of expertise, global accreditations, and pioneering biotech innovation.
Tamsulosin Hydrochloride BP/IP/EP/USP
Date of Issue : 2025-09-24
Valid Till : 2028-07-07
Written Confirmation Number : WC-0165
Address of the Firm : Plot No. A-1/2102 & 2103, Phase-III, G.I.D.C Vapi-396195, Valsad, Gujarat, India
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Tamsulosin Hydrochloride IP/USP/Ph. Eur
Date of Issue : 2025-07-24
Valid Till : 2028-07-21
Written Confirmation Number : WC-0150N
Address of the Firm : API Unit-l, R.S. No. 50/1, Mukteswarapuram Village,\r\nJaggaiahpet Mandal, NTR D...
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SWATI - Transforming science into solutions with 60+ years of expertise, global accreditations, and pioneering biotech innovation.
About the Company : Swati Spentose Pvt. Ltd. (SSPL), part of the 60-year-old V Group, is a globally trusted pharmaceutical manufacturer supplying to 70+ countries. We specialize in high-quality APIs a...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
Temad- We think of world-class quality.
About the Company : Temad Co., established in 1997, is one of Iran's largest API producers and an innovative manufacturer of narcotic and non-narcotic products in the Middle East. It complies with Ira...
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
About the Company : Cohance Lifesciences is a leading CDMO and API platform delivering products and services across the full molecule lifecycle, from development to commercialization. With strong expe...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and r...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
About the Company : Octavius Pharma is a global leader in Directly Compressible Granules with over 45 years of experience in formulation development, manufacturing, and commercialization. Its portfoli...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
Cerata Pharmaceuticals LLP: WHO-GMP Certified Leading Manufacturer & Exporter of Steroid-Hormone & Peptide APIs From India.
About the Company : Cerata Pharmaceuticals LLP is a WHO-GMP certified pharmaceutical API manufacturer based in Gujarat, India. We specialize in the development and manufacturing of high-quality APIs a...
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DOSAGE - CAPSULE;ORAL - 0.4MG
USFDA APPLICATION NUMBER - 20579
DOSAGE - CAPSULE;ORAL - 0.5MG;0.4MG
USFDA APPLICATION NUMBER - 22460
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REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
ABOUT THIS PAGE
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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, 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.
A Harnalidge OCAS manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Harnalidge OCAS, including repackagers and relabelers. The FDA regulates Harnalidge OCAS manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Harnalidge OCAS 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 Harnalidge OCAS manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Harnalidge OCAS supplier is an individual or a company that provides Harnalidge OCAS active pharmaceutical ingredient (API) or Harnalidge OCAS finished formulations upon request. The Harnalidge OCAS suppliers may include Harnalidge OCAS API manufacturers, exporters, distributors and traders.
click here to find a list of Harnalidge OCAS suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Harnalidge OCAS DMF (Drug Master File) is a document detailing the whole manufacturing process of Harnalidge OCAS active pharmaceutical ingredient (API) in detail. Different forms of Harnalidge OCAS DMFs exist exist since differing nations have different regulations, such as Harnalidge OCAS USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Harnalidge OCAS DMF submitted to regulatory agencies in the US is known as a USDMF. Harnalidge OCAS USDMF includes data on Harnalidge OCAS's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Harnalidge OCAS USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Harnalidge OCAS 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 Harnalidge OCAS Drug Master File in Japan (Harnalidge OCAS JDMF) empowers Harnalidge OCAS 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 Harnalidge OCAS JDMF during the approval evaluation for pharmaceutical products. At the time of Harnalidge OCAS 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 Harnalidge OCAS 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 Harnalidge OCAS Drug Master File in Korea (Harnalidge OCAS KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Harnalidge OCAS. The MFDS reviews the Harnalidge OCAS KDMF as part of the drug registration process and uses the information provided in the Harnalidge OCAS KDMF to evaluate the safety and efficacy of the drug.
After submitting a Harnalidge OCAS 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 Harnalidge OCAS API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Harnalidge OCAS suppliers with KDMF on PharmaCompass.
A Harnalidge OCAS CEP of the European Pharmacopoeia monograph is often referred to as a Harnalidge OCAS Certificate of Suitability (COS). The purpose of a Harnalidge OCAS CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Harnalidge OCAS EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Harnalidge OCAS to their clients by showing that a Harnalidge OCAS CEP has been issued for it. The manufacturer submits a Harnalidge OCAS CEP (COS) as part of the market authorization procedure, and it takes on the role of a Harnalidge OCAS CEP holder for the record. Additionally, the data presented in the Harnalidge OCAS CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Harnalidge OCAS DMF.
A Harnalidge OCAS CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Harnalidge OCAS 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 Harnalidge OCAS suppliers with CEP (COS) on PharmaCompass.
A Harnalidge OCAS written confirmation (Harnalidge OCAS WC) is an official document issued by a regulatory agency to a Harnalidge OCAS manufacturer, verifying that the manufacturing facility of a Harnalidge OCAS active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Harnalidge OCAS APIs or Harnalidge OCAS finished pharmaceutical products to another nation, regulatory agencies frequently require a Harnalidge OCAS WC (written confirmation) as part of the regulatory process.
click here to find a list of Harnalidge OCAS 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 Harnalidge OCAS as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Harnalidge OCAS 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 Harnalidge OCAS 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 Harnalidge OCAS and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Harnalidge OCAS NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Harnalidge OCAS suppliers with NDC on PharmaCompass.
Harnalidge OCAS 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 Harnalidge OCAS GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Harnalidge OCAS GMP manufacturer or Harnalidge OCAS GMP API supplier for your needs.
A Harnalidge OCAS CoA (Certificate of Analysis) is a formal document that attests to Harnalidge OCAS's compliance with Harnalidge OCAS specifications and serves as a tool for batch-level quality control.
Harnalidge OCAS CoA mostly includes findings from lab analyses of a specific batch. For each Harnalidge OCAS 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.
Harnalidge OCAS may be tested according to a variety of international standards, such as European Pharmacopoeia (Harnalidge OCAS EP), Harnalidge OCAS JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Harnalidge OCAS USP).
