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List of Drug Master Files (KDMF) for Irinotecan Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 Fermion Oy (1)

02 Jiangsu Hengrui Pharmaceuticals Co., Ltd (1)

03 Laurus Labs Private Limited (1)

04 Qilu Pharmaceutical Co., Ltd (1)

05 Qilu Pharmaceutical Co., Ltd. (5)

06 ScinoPharm Taiwan, Ltd. (1)

07 Shilpa Medicare Limited, Unit-1 (1)

08 Shilpa Pharma Lifesciences Limited (1)

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01 Boryeong Co., Ltd. (1)

02 Hiple Co., Ltd. (1)

03 Iksoo Pharmaceutical Co., Ltd. (1)

04 Kookjeon Pharmaceutical Co., Ltd. (2)

05 Kyungbo Pharmaceutical Co., Ltd. (1)

06 Masung LS Co., Ltd. (1)

07 Otran Farm Korea Co., Ltd. (1)

08 Pharmapia Co., Ltd. (2)

09 Sampoong Pharmachem Co., Ltd. (1)

10 T&S (1)

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01 Irinotecan hydrochloride (12)

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01 China (7)

02 Finland (1)

03 India (3)

04 Taiwan (1)

T&S
2022-01-13
20220113-210-J-1177
Fermion Oy
Finland
Laaketehtaantie 2, Oulu, ...
URL Supplier Web Content
Otran Farm Korea Co., Ltd.
2022-04-08
20220408-210-J-1262
Jiangsu Hengrui Pharmaceu...
China
Jinqiao Road, Dapu Indust...
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Iksoo Pharmaceutical Co., Ltd.
2021-03-16
20210316-210-J-880
Laurus Labs Private Limit...
India
Plot No. 21, Jawaharlal N...
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Kookjeon Pharmaceutical Co., Ltd.
2021-12-06
20201123-210-J-592(4)
Qilu Pharmaceutical Co., ...
China
No. 23999 Gong Ye Bei Roa...
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Pharmapia Co., Ltd.
2021-05-14
20201123-210-J-592(1)
Qilu Pharmaceutical Co., ...
China
No. 23999 Gong Ye Bei Roa...
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Boryeong Co., Ltd.
2021-07-20
20201123-210-J-592(2)
Qilu Pharmaceutical Co., ...
China
No. 23999 Gong Ye Bei Roa...
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Kookjeon Pharmaceutical Co., Ltd.
2021-07-20
20201123-210-J-592(3)
Qilu Pharmaceutical Co., ...
China
No. 243 Gongyebei Road, J...
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Kyungbo Pharmaceutical Co., Ltd.
2023-04-20
20201123-210-J-592(5)
Qilu Pharmaceutical Co., ...
China
No. 23999 Gong Ye Bei Roa...
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Hiple Co., Ltd.
2023-06-30
20230630-210-J-1513
ScinoPharm Taiwan, Ltd.
Taiwan
No. 1, Nan-Ke 8th Road, S...
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Pharmapia Co., Ltd.
2021-11-23
20210210-210-J-700(1)
Shilpa Medicare Limited, ...
India
1A & 1A'P', 1B, 2, 2A, 2B...
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Looking for 100286-90-6 / Irinotecan Hydrochloride API manufacturers, exporters & distributors?

Irinotecan Hydrochloride manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Irinotecan Hydrochloride

Synonyms

100286-90-6, Irinotecan hcl, Topotecin, Campto, Camptothecin 11 hydrochloride, Camptosar

Cas Number

100286-90-6

Unique Ingredient Identifier (UNII)

06X131E4OE

About Irinotecan Hydrochloride

A semisynthetic camptothecin derivative that inhibits DNA TOPOISOMERASE I to prevent nucleic acid synthesis during S PHASE. It is used as an antineoplastic agent for the treatment of COLORECTAL NEOPLASMS and PANCREATIC NEOPLASMS.

Irinotecan Manufacturers

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

Irinotecan Suppliers

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

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

Irinotecan KDMF

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

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

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

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

Irinotecan Manufacturers | Traders | Suppliers

Irinotecan Manufacturers, Traders, Suppliers 1
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We have 6 companies offering Irinotecan

Get in contact with the supplier of your choice:

  1. Fermion Oy
  2. Jiangsu Hengrui Medicine
  3. Laurus Labs
  4. Qilu Antibiotics Pharmaceutical Co., Ltd.
  5. ScinoPharm Taiwan, Ltd
  6. Shilpa Medicare
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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