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API SUPPLIERS
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
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EU-WC
NDC
KDMF
ASMF
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 : 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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Certificate Number : CEP 2023-203 - Rev 00
Status : Valid
Issue Date : 2025-05-09
Type : Chemical
Substance Number : 1681
With Virupaksha, you get a quality product with on-time delivery.
Certificate Number : R1-CEP 2015-203 - Rev 02
Status : Valid
Issue Date : 2023-07-25
Type : Chemical
Substance Number : 1681
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Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Registrant Name : Shinyoung Biotech Co., Ltd.
Registration Date : 2022-01-19
Registration Number : 20141203-161-I-436-13(7)
Manufacturer Name : Supriya Lifescience Ltd.
Manufacturer Address : A-5/2, Lote Parshuram Industrial Area, MIDC Tal-Khed, Dist- Ratnagiri Ratnagiri 41572...
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Registrant Name : Toru Co., Ltd.
Registration Date : 2025-09-17
Registration Number : 20141203-161-I-436-13(12)
Manufacturer Name : Supriya Lifescience Ltd.
Manufacturer Address : A-5/2, Lote Parshuram Industrial Area, MIDC Tal-Khed, Dist- Ratnagiri Ratnagiri 41572...
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Registrant Name : Hiple Co., Ltd.
Registration Date : 2019-12-16
Registration Number : 20141203-161-I-436-13(3)
Manufacturer Name : Supriya Lifescience Ltd.
Manufacturer Address : A-5/2, Lote Parshuram Industrial Area, MIDC Tal-Khed, Dist- Ratnagiri Ratnagiri 41572...
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Registrant Name : Base Farm Co., Ltd.
Registration Date : 2019-11-20
Registration Number : 20141203-161-I-436-13(2)
Manufacturer Name : Supriya Lifescience Ltd.
Manufacturer Address : A-5/2, Lote Parshuram Industrial Area, MIDC Tal-Khed, Dist- Ratnagiri Ratnagiri 41572...
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Registrant Name : Huseeed Co., Ltd.
Registration Date : 2021-12-24
Registration Number : 20141203-161-I-436-13(6)
Manufacturer Name : Supriya Lifescience Ltd.
Manufacturer Address : A-5/2, Lote Parshuram Industrial Area, MIDC Tal.-Khed, Dist.-Ratnagiri, Pin- 415 722,...
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Registrant Name : Nuri Pharmtech
Registration Date : 2020-03-26
Registration Number : 20141203-161-I-436-13(4)
Manufacturer Name : Supriya Lifescience Ltd.
Manufacturer Address : A-5/2, Lote Parshuram Industrial Area, MIDC Tal-Khed, Dist- Ratnagiri Ratnagiri 41572...
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Registrant Name : Wonpung Pharmaceutical Co., Ltd.
Registration Date : 2020-07-14
Registration Number : 20141203-161-I-436-13(5)
Manufacturer Name : Supriya Lifescience Ltd.
Manufacturer Address : A-5/2, Lote Parshuram Industrial Area, MIDC Tal-Khed, Dist- Ratnagiri Ratnagiri 41572...
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Registrant Name : IMCD Korea Co., Ltd.
Registration Date : 2024-07-17
Registration Number : 20141203-161-I-436-13(10)
Manufacturer Name : Supriya Lifescience Ltd
Manufacturer Address : A-5/2, Lote Parshuram Industrial Area, MIDC, Tal-Khed, Dist.-Ratnagiri, 415722, Mahar...
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Registrant Name : Daeshin Pharmaceutical Co., Ltd.
Registration Date : 2024-01-05
Registration Number : 20141203-161-I-436-13(8)
Manufacturer Name : Supriya Lifescience Ltd
Manufacturer Address : A-5/2, Lote Parshuram Industrial Area, MIDC, Tal-Khed, Dist-Ratnagiri, 415722 Maharas...
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Registrant Name : Sanil Pharmaceutical Co., Ltd.
Registration Date : 2024-06-28
Registration Number : 20141203-161-I-436-13(9)
Manufacturer Name : Supriya Lifescience Limited
Manufacturer Address : A-5/2, Lote-Parshuram Industrial Area, MIDC, Tal-Khed, Dist-Ratnagiri, Maharashtra, 4...
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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 is a globally recognized, technology-driven manufacturer of APIs , CDMO & formulations, established in 1987. Headquartered in Mumbai, India, we operate ...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
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 : Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in th...
IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
About the Company : Established in 1990, Inabata France, a part of the Inabata Group, used to export chemical and pharmaceutical products to Japan. In 2006, it acquired Pharmasynthèse. Today, Inabata...
Temad- We think of world-class quality.
About the Company : Established in 1997, Temad Co. is one of the largest producers of APIs in Iran & an innovative manufacturer of narcotic and non-narcotic products of world-class quality in the Midd...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
About the Company : Rusan Pharma is a fully integrated global pharmaceutical company specializing in the treatment of addiction & pain management. We manufacture & market a wide range of APIs & formul...
With Virupaksha, you get a quality product with on-time delivery.
About the Company : Virupaksha Organics, founded in 2003 by G. Chandra Mouliswar Reddy, is committed to delivering products of the utmost quality to its customers. In a span of less than 20 years, the...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
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Drugs in Development
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Tramadol Zentiva
Dosage Form : Hard Capsule
Dosage Strength : 50mg
Packaging :
Approval Date : 25/06/1997
Application Number : 52900
Regulatory Info : Allowed
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Tramadol Zentiva; L?sung zum Einnehmen
Dosage Form : Oral Solution
Dosage Strength : 100mg/ml
Packaging :
Approval Date : 25/06/1997
Application Number : 52901
Regulatory Info : Allowed
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Tramadol retard Zentiva
Dosage Form : Film Coated Tablet
Dosage Strength : 100mg
Packaging :
Approval Date : 12/11/2004
Application Number : 56704
Regulatory Info : Allowed
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Tramadol retard Zentiva
Dosage Form : Film Coated Tablet
Dosage Strength : 150mg
Packaging :
Approval Date : 12/11/2004
Application Number : 56704
Regulatory Info : Allowed
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Tramadol retard Zentiva
Dosage Form : Film Coated Tablet
Dosage Strength : 200mg
Packaging :
Approval Date : 12/11/2004
Application Number : 56704
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info :
Registration Country : Norway
Tramadol Hydrochloride; Acetaminophen/Paracetamol
Brand Name : Tramadol/Acetaminophen Orion
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 37.5MG; 325MG
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Tramadol Hydrochloride; Acetaminophen/Paracetamol
Brand Name : Tramadol/Acetaminophen Orion
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 37.5MG; 325MG
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : Deregistered
Registration Country : Sweden
Paracetamol; Tramadolhydroklorid
Brand Name : Tramadol/Paracetamol Orion
Dosage Form : Film Coated Tablet
Dosage Strength : 37.5mg;325mg
Packaging :
Approval Date : 09/04/2015
Application Number : 20131102000019
Regulatory Info : Deregistered
Registration Country : Sweden
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info : Authorized
Registration Country : Spain
Paracetamol; Tramadol Hydrochloride
Brand Name : Tramadol/Paracetamol Pensa
Dosage Form : Tablet
Dosage Strength : 37.5MG; 325 MG
Packaging :
Approval Date : 2012-11-27
Application Number : 76252
Regulatory Info : Authorized
Registration Country : Spain
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Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Tramaspen SR 100mg
Dosage Form : SRT
Dosage Strength : 100mg
Packaging : 60X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Tramaspen SR 150mg
Dosage Form : SRT
Dosage Strength : 150mg
Packaging : 60X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Tramaspen SR 200mg
Dosage Form : SRT
Dosage Strength : 200mg
Packaging : 60X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Tramaspen Co
Dosage Form : FCT
Dosage Strength : 37.5mg
Packaging : 60X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Tramaspen 100 Mg/2 Ml
Dosage Form : INJ
Dosage Strength : 100mg/2 ml
Packaging : 2X5mg/2 ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Tramaspen 50 mg
Dosage Form : CAP
Dosage Strength : 50mg
Packaging : 100X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Tramaspen 50 mg
Dosage Form : CAP
Dosage Strength : 50mg
Packaging : 20X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Dossiers
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 50MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Extended Release Table...
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Extended Release Table...
Dosage Strength : 200MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Extended Release Table...
Dosage Strength : 300MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Regulatory Info :
Registration Country : India
Tramadol Hydrochloride; Paracetamol
Brand Name :
Dosage Form : Injection
Dosage Strength : 37.5MG; 325MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.
Regulatory Info :
Registration Country : France
Tramadol Hydrochloride; Paracetamol
Brand Name : Tramadol;Paracetamol
Dosage Form : Tablet
Dosage Strength : 37.5MG; 325MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : France
Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.
Regulatory Info :
Registration Country : France
Tramadol Hydrochloride; Paracetamol
Brand Name : Tramadol;Paracetamol
Dosage Form : Oro-Dispersible Tablet
Dosage Strength : 37.5MG; 325MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : France
Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.
Regulatory Info :
Registration Country : France
Tramadol Hydrochloride; Paracetamol
Brand Name : Tramadol;Paracetamol
Dosage Form : Taste Masked Granules ...
Dosage Strength : 37.5MG; 325MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : France
Temad- We think of world-class quality.
Regulatory Info :
Registration Country : Iran
Brand Name :
Dosage Form : Tablet
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
Temad- We think of world-class quality.
Regulatory Info :
Registration Country : Iran
Brand Name :
Dosage Form : Tablet
Dosage Strength : 200MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
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
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
USP reference standards; highly characterized specimens of drug substances, impurities, excipients, degradation products & more.
1,6-Dehydro Tramadol Hydrochloride
CAS Number : 66170-31-8
Quantity Per Vial :
Price ($) : 1200
Catalog Number : 1A07770
Current Lot :
Previous Lot :
NDC Code :
ANALYTICAL
ABOUT THIS PAGE
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PharmaCompass offers a list of Tramadol Hydrochloride 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 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.
PharmaCompass also assists you with knowing the Tramadol Hydrochloride API Price utilized in the formulation of products. Tramadol Hydrochloride API Price is not always fixed or binding as the Tramadol Hydrochloride Price is obtained through a variety of data sources. The Tramadol Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Xymel 50 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Xymel 50, including repackagers and relabelers. The FDA regulates Xymel 50 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Xymel 50 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 Xymel 50 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Xymel 50 supplier is an individual or a company that provides Xymel 50 active pharmaceutical ingredient (API) or Xymel 50 finished formulations upon request. The Xymel 50 suppliers may include Xymel 50 API manufacturers, exporters, distributors and traders.
click here to find a list of Xymel 50 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Xymel 50 DMF (Drug Master File) is a document detailing the whole manufacturing process of Xymel 50 active pharmaceutical ingredient (API) in detail. Different forms of Xymel 50 DMFs exist exist since differing nations have different regulations, such as Xymel 50 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Xymel 50 DMF submitted to regulatory agencies in the US is known as a USDMF. Xymel 50 USDMF includes data on Xymel 50's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Xymel 50 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Xymel 50 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 Xymel 50 Drug Master File in Japan (Xymel 50 JDMF) empowers Xymel 50 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 Xymel 50 JDMF during the approval evaluation for pharmaceutical products. At the time of Xymel 50 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 Xymel 50 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 Xymel 50 Drug Master File in Korea (Xymel 50 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Xymel 50. The MFDS reviews the Xymel 50 KDMF as part of the drug registration process and uses the information provided in the Xymel 50 KDMF to evaluate the safety and efficacy of the drug.
After submitting a Xymel 50 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 Xymel 50 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Xymel 50 suppliers with KDMF on PharmaCompass.
A Xymel 50 CEP of the European Pharmacopoeia monograph is often referred to as a Xymel 50 Certificate of Suitability (COS). The purpose of a Xymel 50 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Xymel 50 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Xymel 50 to their clients by showing that a Xymel 50 CEP has been issued for it. The manufacturer submits a Xymel 50 CEP (COS) as part of the market authorization procedure, and it takes on the role of a Xymel 50 CEP holder for the record. Additionally, the data presented in the Xymel 50 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Xymel 50 DMF.
A Xymel 50 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Xymel 50 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 Xymel 50 suppliers with CEP (COS) on PharmaCompass.
A Xymel 50 written confirmation (Xymel 50 WC) is an official document issued by a regulatory agency to a Xymel 50 manufacturer, verifying that the manufacturing facility of a Xymel 50 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Xymel 50 APIs or Xymel 50 finished pharmaceutical products to another nation, regulatory agencies frequently require a Xymel 50 WC (written confirmation) as part of the regulatory process.
click here to find a list of Xymel 50 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 Xymel 50 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Xymel 50 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 Xymel 50 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 Xymel 50 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Xymel 50 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Xymel 50 suppliers with NDC on PharmaCompass.
Xymel 50 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 Xymel 50 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 Xymel 50 GMP manufacturer or Xymel 50 GMP API supplier for your needs.
A Xymel 50 CoA (Certificate of Analysis) is a formal document that attests to Xymel 50's compliance with Xymel 50 specifications and serves as a tool for batch-level quality control.
Xymel 50 CoA mostly includes findings from lab analyses of a specific batch. For each Xymel 50 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.
Xymel 50 may be tested according to a variety of international standards, such as European Pharmacopoeia (Xymel 50 EP), Xymel 50 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Xymel 50 USP).
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