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List of Korea Drug Master Files (KDMF) for erlotinib HCl Active Pharmaceutical Ingredient submitted to the Review Authority in Korea and listed on PharmaCompass.com

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Korea United Pharmaceutical Co., Ltd.
2012-06-26
Number 4838-11-ND(3)
Cipla Limited
India
Plot No. 285, 286 and 287...
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Ildong Pharmaceutical Co., Ltd.
2011-06-30
Number 4838-11-ND(1)
Cipla Limited.
India
Plot No. 285, 286 and 287...
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UNUST Co., Ltd.
2010-12-30
Number 4838-11-ND
Cipla Limited
India
Plot No. 285, 286 and 287...
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Chong Kun Dang Co., Ltd.
2016-08-09
Number 4838-11-ND(4)
Cipla Limited.
India
Plot No. 285, 286 and 287...
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Boryeong Co., Ltd.
2011-08-12
Number 4838-11-ND(2)
Cipla Limited
India
Plot No. 285, 286 and 287...
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Korea Roche Co., Ltd.
2005-07-28
Number 184-2-ND
F. Hoffmann-La Roche Ltd
Switzerland
Grenzacherstrasse 124 CH-...
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Jeil Pharmaceutical Co., Ltd.
2012-08-14
21-8-ND
Jeil Pharmaceutical Co., ...
South Korea
7, Cheongganggachang-ro, ...
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Kyungbo Pharmaceutical Co., Ltd.
2018-11-16
1673-29-ND
Kyungbo Pharmaceutical Co...
South Korea
174, Silok-ro, Asan-si, C...
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Masung LS Co., Ltd.
2023-05-19
Wed163-31-ND
MSN Laboratories Private ...
India
Unit-II, Sy. No. 50, Kard...
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Handok Teva Co., Ltd.
2016-02-01
Number 6414-1-ND
Natco Pharma Ltd., Chemic...
India
Mekaguda(Village), Nandig...
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Masung LS Co., Ltd.
2017-02-15
Wed163-12-ND
Shilpa Pharma Lifescience...
India
Plot Nos. 33, 33a, 40-47,...
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Pharma Science Korea Co., Ltd.
2017-03-29
Number 711-16-ND(1)
Sicor de Mexico S.A. de C...
Mexico
Av. San Rafael No. 35, Pa...
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Samo Pharmaceutical Co., Ltd.
2013-12-04
Number 711-16-ND
Sicor de Mexico S.A. De C...
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Av. San Rafael No. 35, Pa...
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Sungjin Exim Co., Ltd.
2012-09-12
Number 5556-1-ND
Uquifa Mexico S.A. de CV
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Calle 37 Este No 126, CIV...
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  • TABLET;ORAL - EQ 100MG BASE
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  • TABLET;ORAL - EQ 25MG BASE

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 KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a erlotinib HCl Drug Master File in Korea (erlotinib HCl KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of erlotinib HCl. The MFDS reviews the erlotinib HCl KDMF as part of the drug registration process and uses the information provided in the erlotinib HCl KDMF to evaluate the safety and efficacy of the drug.

After submitting a erlotinib HCl 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 erlotinib HCl API can apply through the Korea Drug Master File (KDMF).

click here to find a list of erlotinib HCl suppliers with KDMF on PharmaCompass.

erlotinib HCl Manufacturers | Traders | Suppliers

erlotinib HCl Manufacturers, Traders, Suppliers 1
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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