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DRUG PRODUCT COMPOSITIONS
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Data Compilation #PharmaFlow
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API SUPPLIERS
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USDMF
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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Date of Issue : 2024-04-03
Valid Till : 2027-01-21
Written Confirmation Number : WC-0493
Address of the Firm : Unit-IV, Plot No: 34B, 40B & 60B, J.N. Pharma City, Thanam (V), Parawada (M), An...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 2022-07-28
Valid Till : 2025-12-30
Written Confirmation Number : WC-0390
Address of the Firm : Devunipalavalasa Village, Ranasthalam Mandal, Srikakulam District -532409, Andhr...
Lee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.
Date of Issue : 2022-06-15
Valid Till : 2025-07-28
Written Confirmation Number : WC-0186
Address of the Firm : Sy. No. 10/G-1, Gaddapotharam (V), Jinnaram (M), Sangareddy District, Pincode 50...
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Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
About the Company : MINAKEM is a cGMP custom manufacturer of small molecule API, HPAPI and steroids. All development and manufacturing activities are supported by highly skilled R&D teams, supported b...
Minakem is manufacturing small molecules APIs including corticosteroids
About the Company : Minakem Montreal is developing and manufacturing small molecules APIs and advanced intermediates, including corticosteroids. Following efficient processes and methodologies, our em...
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...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
About the Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, corticosteroids, cyto...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological API...
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 ...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
About the Company : Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for critical and high-g...
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...
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Rochem International Inc
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ABOUT THIS PAGE
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PharmaCompass offers a list of Tofacitinib Citrate 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 Tofacitinib Citrate manufacturer or Tofacitinib Citrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tofacitinib Citrate manufacturer or Tofacitinib Citrate supplier.
PharmaCompass also assists you with knowing the Tofacitinib Citrate API Price utilized in the formulation of products. Tofacitinib Citrate API Price is not always fixed or binding as the Tofacitinib Citrate Price is obtained through a variety of data sources. The Tofacitinib Citrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Tofacitinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tofacitinib, including repackagers and relabelers. The FDA regulates Tofacitinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tofacitinib 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 Tofacitinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tofacitinib supplier is an individual or a company that provides Tofacitinib active pharmaceutical ingredient (API) or Tofacitinib finished formulations upon request. The Tofacitinib suppliers may include Tofacitinib API manufacturers, exporters, distributors and traders.
click here to find a list of Tofacitinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tofacitinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Tofacitinib active pharmaceutical ingredient (API) in detail. Different forms of Tofacitinib DMFs exist exist since differing nations have different regulations, such as Tofacitinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tofacitinib DMF submitted to regulatory agencies in the US is known as a USDMF. Tofacitinib USDMF includes data on Tofacitinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tofacitinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tofacitinib 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 Tofacitinib Drug Master File in Japan (Tofacitinib JDMF) empowers Tofacitinib 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 Tofacitinib JDMF during the approval evaluation for pharmaceutical products. At the time of Tofacitinib 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 Tofacitinib 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 Tofacitinib Drug Master File in Korea (Tofacitinib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tofacitinib. The MFDS reviews the Tofacitinib KDMF as part of the drug registration process and uses the information provided in the Tofacitinib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tofacitinib 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 Tofacitinib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tofacitinib suppliers with KDMF on PharmaCompass.
A Tofacitinib written confirmation (Tofacitinib WC) is an official document issued by a regulatory agency to a Tofacitinib manufacturer, verifying that the manufacturing facility of a Tofacitinib active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tofacitinib APIs or Tofacitinib finished pharmaceutical products to another nation, regulatory agencies frequently require a Tofacitinib WC (written confirmation) as part of the regulatory process.
click here to find a list of Tofacitinib 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 Tofacitinib as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tofacitinib 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 Tofacitinib 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 Tofacitinib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tofacitinib NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tofacitinib suppliers with NDC on PharmaCompass.
Tofacitinib 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 Tofacitinib 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 Tofacitinib GMP manufacturer or Tofacitinib GMP API supplier for your needs.
A Tofacitinib CoA (Certificate of Analysis) is a formal document that attests to Tofacitinib's compliance with Tofacitinib specifications and serves as a tool for batch-level quality control.
Tofacitinib CoA mostly includes findings from lab analyses of a specific batch. For each Tofacitinib 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.
Tofacitinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Tofacitinib EP), Tofacitinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tofacitinib USP).
