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List of Japan Drug Master File (JDMF) for erlotinib HCl Active Pharmaceutical Ingredient submitted to the Review Authority in Japan (PMDA) and listed on PharmaCompass.com

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7-2-A2,Hetero Corporate,Industrial ...
2022-11-09
2022-02-17
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Looking for 183319-69-9 / Erlotinib Hydrochloride API manufacturers, exporters & distributors?

Erlotinib Hydrochloride manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Erlotinib 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 Erlotinib Hydrochloride manufacturer or Erlotinib Hydrochloride supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Erlotinib Hydrochloride manufacturer or Erlotinib Hydrochloride supplier.

PharmaCompass also assists you with knowing the Erlotinib Hydrochloride API Price utilized in the formulation of products. Erlotinib Hydrochloride API Price is not always fixed or binding as the Erlotinib Hydrochloride Price is obtained through a variety of data sources. The Erlotinib Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Erlotinib Hydrochloride

Synonyms

183319-69-9, Erlotinib hcl, Tarceva, Osi-774, N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine hydrochloride, Osi 774

Cas Number

183319-69-9

Unique Ingredient Identifier (UNII)

DA87705X9K

About Erlotinib Hydrochloride

A quinazoline derivative and ANTINEOPLASTIC AGENT that functions as a PROTEIN KINASE INHIBITOR for EGFR associated tyrosine kinase. It is used in the treatment of NON-SMALL CELL LUNG CANCER.

erlotinib HCl Manufacturers

A erlotinib HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of erlotinib HCl, including repackagers and relabelers. The FDA regulates erlotinib HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. erlotinib HCl 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 erlotinib HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

erlotinib HCl Suppliers

A erlotinib HCl supplier is an individual or a company that provides erlotinib HCl active pharmaceutical ingredient (API) or erlotinib HCl finished formulations upon request. The erlotinib HCl suppliers may include erlotinib HCl API manufacturers, exporters, distributors and traders.

click here to find a list of erlotinib HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

erlotinib HCl JDMF

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 erlotinib HCl Drug Master File in Japan (erlotinib HCl JDMF) empowers erlotinib HCl 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 erlotinib HCl JDMF during the approval evaluation for pharmaceutical products. At the time of erlotinib HCl 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 erlotinib HCl suppliers with JDMF on PharmaCompass.

erlotinib HCl Manufacturers | Traders | Suppliers

erlotinib HCl Manufacturers, Traders, Suppliers 1
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We have 1 companies offering erlotinib HCl

Get in contact with the supplier of your choice:

  1. Hetero Drugs
Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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