Synopsis
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VMF
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
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API SUPPLIERS
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
Temad- We think of world-class quality.
Jai Radhe Sales is your partner for all your sourcing needs.
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
With Virupaksha, you get a quality product with on-time delivery.
CEP/COS 
EU-WC
NDC
KDMF
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
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USDMF
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41226
Submission : 2025-09-26
Status :
Type : II
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39533
Submission : 2024-02-29
Status :
Type : II
With Virupaksha, you get a quality product with on-time delivery.
GDUFA
DMF Review : Complete
Rev. Date : 2018-08-01
Pay. Date : 2018-02-20
DMF Number : 30504
Submission : 2016-04-22
Status :
Type : II
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Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
About the Company : Supriya Lifescience Limited, established in 1987 and headquartered in Mumbai, is a globally recognized, technology-driven manufacturer of APIs, CDMO, and formulations. Its faciliti...
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...
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
About the Company : Nuray Chemicals Pvt Ltd, established in 2012 near Chennai, is an API manufacturer for highly regulated markets. Its state-of-the-art R&D facility specializes in synthesizing NCEs, ...
IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
About the Company : Inabata France, established in 1990 and part of the Inabata Group, acquired Pharmasynthèse in 2006. Today, Inabata-Pharmasynthèse offers sourcing, manufacturing, and development ...
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...
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...
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
About the Company : Rusan Pharma is a global pharmaceutical company specializing in addiction and pain management, manufacturing APIs and formulations for controlled substances. Its facilities are GMP...
With Virupaksha, you get a quality product with on-time delivery.
About the Company : Virupaksha Organics, founded in 2003, is a leading manufacturer of APIs and intermediates. Its FDA-audited, ISO-certified facilities in Kazipally and Pashamylaram produce high-qual...
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...
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DOSAGE - TABLET;ORAL - 100MG **Federal Regist...DOSAGE - TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20281
DOSAGE - TABLET;ORAL - 50MG **Federal Registe...DOSAGE - TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20281
DOSAGE - TABLET;ORAL - 325MG;37.5MG **Federal...DOSAGE - TABLET;ORAL - 325MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21123
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 100M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21692
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 200M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21692
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 300M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21692
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 100M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21745
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 200M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21745
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 300M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21745
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 100...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 100MG
USFDA APPLICATION NUMBER - 22370
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 150...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 150MG
USFDA APPLICATION NUMBER - 22370
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 200...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 200MG
USFDA APPLICATION NUMBER - 22370
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 300...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 300MG
USFDA APPLICATION NUMBER - 22370
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REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
ABOUT THIS PAGE
68
PharmaCompass offers a list of Tramadol Hydrochloride 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 Tramadol Hydrochloride manufacturer or Tramadol Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tramadol Hydrochloride manufacturer or Tramadol Hydrochloride supplier.
A Tadol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tadol, including repackagers and relabelers. The FDA regulates Tadol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tadol 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 Tadol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Tadol supplier is an individual or a company that provides Tadol active pharmaceutical ingredient (API) or Tadol finished formulations upon request. The Tadol suppliers may include Tadol API manufacturers, exporters, distributors and traders.
click here to find a list of Tadol suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Tadol DMF (Drug Master File) is a document detailing the whole manufacturing process of Tadol active pharmaceutical ingredient (API) in detail. Different forms of Tadol DMFs exist exist since differing nations have different regulations, such as Tadol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tadol DMF submitted to regulatory agencies in the US is known as a USDMF. Tadol USDMF includes data on Tadol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tadol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tadol 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 Tadol Drug Master File in Japan (Tadol JDMF) empowers Tadol 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 Tadol JDMF during the approval evaluation for pharmaceutical products. At the time of Tadol 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 Tadol 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 Tadol Drug Master File in Korea (Tadol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tadol. The MFDS reviews the Tadol KDMF as part of the drug registration process and uses the information provided in the Tadol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tadol 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 Tadol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tadol suppliers with KDMF on PharmaCompass.
A Tadol CEP of the European Pharmacopoeia monograph is often referred to as a Tadol Certificate of Suitability (COS). The purpose of a Tadol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Tadol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Tadol to their clients by showing that a Tadol CEP has been issued for it. The manufacturer submits a Tadol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Tadol CEP holder for the record. Additionally, the data presented in the Tadol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Tadol DMF.
A Tadol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Tadol 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 Tadol suppliers with CEP (COS) on PharmaCompass.
A Tadol written confirmation (Tadol WC) is an official document issued by a regulatory agency to a Tadol manufacturer, verifying that the manufacturing facility of a Tadol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tadol APIs or Tadol finished pharmaceutical products to another nation, regulatory agencies frequently require a Tadol WC (written confirmation) as part of the regulatory process.
click here to find a list of Tadol 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 Tadol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tadol 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 Tadol 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 Tadol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tadol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tadol suppliers with NDC on PharmaCompass.
Tadol 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 Tadol GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Tadol GMP manufacturer or Tadol GMP API supplier for your needs.
A Tadol CoA (Certificate of Analysis) is a formal document that attests to Tadol's compliance with Tadol specifications and serves as a tool for batch-level quality control.
Tadol CoA mostly includes findings from lab analyses of a specific batch. For each Tadol 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.
Tadol may be tested according to a variety of international standards, such as European Pharmacopoeia (Tadol EP), Tadol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tadol USP).
