Synopsis
0
CEP/COS
0
VMF
DRUG PRODUCT COMPOSITIONS
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
About the Company : ChemWerth, established in 1982, is a US-headquartered full-service generic API company. It supplies cGMP-quality APIs to regulated markets worldwide, with exclusive partnerships fo...
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 specializing in small molecule APIs, HPAPIs, and steroids. Its highly skilled R&D teams, supported by strong analytical and regulatory service...
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 APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...
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 ...
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Rochem, established in 1994, is a global distributor of pharmaceutical, food, nutritional, and animal health ingredients, sourcing high-quality products from China. Headquartered i...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : Shanghai Minbiotech is specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square meters of R&D centers in...
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. Founded by young entrepreneurs and experienced research and manufac...
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...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
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, founded in 1980 by Mr. M L N Sastry, is a leader in manufacturing ephedrine and pseudoephedrine salts. It is now the top AP...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Boai NKY Pharmaceuticals Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kirsch Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Dr. Paul Lohmann GmbH & Co. KGaA
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ACG Worldwide
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ashland
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Corel Pharma Chem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Esteem Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gloria Interchem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Keval Exports
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kima Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Bold Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Neelkanth MineChem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nitika Pharmaceutical Specialities
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nomisma Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qianhao Chemical (Hebei) Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qualicaps
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Silverline Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Coating Systems & Additives
Fillers, Diluents & Binders
Solubilizers
Controlled & Modified Release
Thickeners and Stabilizers
Granulation
Disintegrants & Superdisintegrants
Direct Compression
Topical
Lubricants & Glidants
Film Formers & Plasticizers
Co-Processed Excipients
Parenteral
Emulsifying Agents
Empty Capsules
API Stability Enhancers
Taste Masking
Chewable & Orodispersible Aids
Vegetarian Capsules
Surfactant & Foaming Agents
Rheology Modifiers
Coloring Agents
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
35
PharmaCompass offers a list of Lapatinib Ditosylate 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 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.
A Lapatinib Ditosylate,Tykerb manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lapatinib Ditosylate,Tykerb, including repackagers and relabelers. The FDA regulates Lapatinib Ditosylate,Tykerb manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lapatinib Ditosylate,Tykerb 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 Lapatinib Ditosylate,Tykerb manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Lapatinib Ditosylate,Tykerb supplier is an individual or a company that provides Lapatinib Ditosylate,Tykerb active pharmaceutical ingredient (API) or Lapatinib Ditosylate,Tykerb finished formulations upon request. The Lapatinib Ditosylate,Tykerb suppliers may include Lapatinib Ditosylate,Tykerb API manufacturers, exporters, distributors and traders.
click here to find a list of Lapatinib Ditosylate,Tykerb suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Lapatinib Ditosylate,Tykerb DMF (Drug Master File) is a document detailing the whole manufacturing process of Lapatinib Ditosylate,Tykerb active pharmaceutical ingredient (API) in detail. Different forms of Lapatinib Ditosylate,Tykerb DMFs exist exist since differing nations have different regulations, such as Lapatinib Ditosylate,Tykerb USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lapatinib Ditosylate,Tykerb DMF submitted to regulatory agencies in the US is known as a USDMF. Lapatinib Ditosylate,Tykerb USDMF includes data on Lapatinib Ditosylate,Tykerb's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lapatinib Ditosylate,Tykerb USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lapatinib Ditosylate,Tykerb 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 Lapatinib Ditosylate,Tykerb Drug Master File in Japan (Lapatinib Ditosylate,Tykerb JDMF) empowers Lapatinib Ditosylate,Tykerb 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 Lapatinib Ditosylate,Tykerb JDMF during the approval evaluation for pharmaceutical products. At the time of Lapatinib Ditosylate,Tykerb 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 Lapatinib Ditosylate,Tykerb 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 Lapatinib Ditosylate,Tykerb Drug Master File in Korea (Lapatinib Ditosylate,Tykerb KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lapatinib Ditosylate,Tykerb. The MFDS reviews the Lapatinib Ditosylate,Tykerb KDMF as part of the drug registration process and uses the information provided in the Lapatinib Ditosylate,Tykerb KDMF to evaluate the safety and efficacy of the drug.
After submitting a Lapatinib Ditosylate,Tykerb 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 Lapatinib Ditosylate,Tykerb API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Lapatinib Ditosylate,Tykerb suppliers with KDMF on PharmaCompass.
A Lapatinib Ditosylate,Tykerb written confirmation (Lapatinib Ditosylate,Tykerb WC) is an official document issued by a regulatory agency to a Lapatinib Ditosylate,Tykerb manufacturer, verifying that the manufacturing facility of a Lapatinib Ditosylate,Tykerb active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Lapatinib Ditosylate,Tykerb APIs or Lapatinib Ditosylate,Tykerb finished pharmaceutical products to another nation, regulatory agencies frequently require a Lapatinib Ditosylate,Tykerb WC (written confirmation) as part of the regulatory process.
click here to find a list of Lapatinib Ditosylate,Tykerb 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 Lapatinib Ditosylate,Tykerb as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Lapatinib Ditosylate,Tykerb 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 Lapatinib Ditosylate,Tykerb 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 Lapatinib Ditosylate,Tykerb and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lapatinib Ditosylate,Tykerb NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Lapatinib Ditosylate,Tykerb suppliers with NDC on PharmaCompass.
Lapatinib Ditosylate,Tykerb 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 Lapatinib Ditosylate,Tykerb GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Lapatinib Ditosylate,Tykerb GMP manufacturer or Lapatinib Ditosylate,Tykerb GMP API supplier for your needs.
A Lapatinib Ditosylate,Tykerb CoA (Certificate of Analysis) is a formal document that attests to Lapatinib Ditosylate,Tykerb's compliance with Lapatinib Ditosylate,Tykerb specifications and serves as a tool for batch-level quality control.
Lapatinib Ditosylate,Tykerb CoA mostly includes findings from lab analyses of a specific batch. For each Lapatinib Ditosylate,Tykerb 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.
Lapatinib Ditosylate,Tykerb may be tested according to a variety of international standards, such as European Pharmacopoeia (Lapatinib Ditosylate,Tykerb EP), Lapatinib Ditosylate,Tykerb JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lapatinib Ditosylate,Tykerb USP).
