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API SUPPLIERS
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USDMF
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34836
Submission : 2021-02-05
Status :
Type : II
Minakem is manufacturing small molecules APIs including corticosteroids
GDUFA
DMF Review : Complete
Rev. Date : 2018-12-03
Pay. Date : 2018-01-24
DMF Number : 32266
Submission : 2018-01-17
Status :
Type : II
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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
About the Company : Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs ...
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, ...
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...
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...
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...
Sumar Biotech work together to Innovate & Manufacture Semi-synthetic, Synthetic & Fermentation API.
About the Company : Sumar Biotech LLP, registered in January 2018, is a startup approved by the Gujarat State Biotechnology Mission. It was founded by emerging entrepreneurs and a team of young yet ex...
Lee Fine Chem: Advancing Innovation and Quality in Intermediates, APIs, and Dosage Forms for Superior Pharmaceutical Solutions.
About the Company : Lee Fine Chem Private Limited specializes in Advanced Intermediates, Active Pharmaceutical Ingredients (APIs), and Finished Dosage Forms. With a strong focus on quality and innovat...
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Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
3-Chloro-4[(3-fluorobenzyl)oxy]aniline
CAS Number : 202197-26-0
End Use API : Lapatinib Ditosylate
About The Company : Malladi Drugs & Pharmaceuticals Ltd was founded in 1980 by microbiologist Mr. M L N Sastry. Within a few years, Malladi established itself as a leader in manufa...
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Lapatinib Ditosylate 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 Lapatinib Ditosylate manufacturer or Lapatinib Ditosylate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lapatinib Ditosylate manufacturer or Lapatinib Ditosylate supplier.
PharmaCompass also assists you with knowing the Lapatinib Ditosylate API Price utilized in the formulation of products. Lapatinib Ditosylate API Price is not always fixed or binding as the Lapatinib Ditosylate Price is obtained through a variety of data sources. The Lapatinib Ditosylate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate, including repackagers and relabelers. The FDA regulates Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate 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 Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate supplier is an individual or a company that provides Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate active pharmaceutical ingredient (API) or Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate finished formulations upon request. The Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate suppliers may include Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate API manufacturers, exporters, distributors and traders.
click here to find a list of Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate active pharmaceutical ingredient (API) in detail. Different forms of Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate DMFs exist exist since differing nations have different regulations, such as Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate DMF submitted to regulatory agencies in the US is known as a USDMF. Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate USDMF includes data on Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate 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 Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate Drug Master File in Japan (Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate JDMF) empowers Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate 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 Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate JDMF during the approval evaluation for pharmaceutical products. At the time of Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate 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 Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate 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 Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate Drug Master File in Korea (Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate. The MFDS reviews the Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate KDMF as part of the drug registration process and uses the information provided in the Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate 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 Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate suppliers with KDMF on PharmaCompass.
A Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate written confirmation (Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate WC) is an official document issued by a regulatory agency to a Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate manufacturer, verifying that the manufacturing facility of a Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate APIs or Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate finished pharmaceutical products to another nation, regulatory agencies frequently require a Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate WC (written confirmation) as part of the regulatory process.
click here to find a list of Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate 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 Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate 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 Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate 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 Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate suppliers with NDC on PharmaCompass.
Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate 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 Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate 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 Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate GMP manufacturer or Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate GMP API supplier for your needs.
A Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate CoA (Certificate of Analysis) is a formal document that attests to Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate's compliance with Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate specifications and serves as a tool for batch-level quality control.
Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate CoA mostly includes findings from lab analyses of a specific batch. For each Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate 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.
Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate may be tested according to a variety of international standards, such as European Pharmacopoeia (Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate EP), Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tykerb, Tyverb, GW-572016, Lapatinib Ditosylate USP).
