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

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01 Evonik Corporation (1)

02 Moehs Cantabra SL_x000D_ (1)

03 Alembic Pharmaceuticals Limited (1)

04 Asia Chemical Industries Ltd. (1)

05 Dasan Pharmaceutical Co., Ltd. @[Manufacturer of starting material 'duloxetine hydrochloride'] SCI Pharmtech, Inc. (1)

06 Hanseochem Co., Ltd. (1)

07 Hetero Drugs Limited (2)

08 Hetero Drugs Limited. (1)

09 Ildong Pharmaceutical Co., Ltd. (1)

10 Inist ST Co., Ltd. (1)

11 Korea Biochem Pharmaceutical Co., Ltd. (1)

12 Kyungbo Pharmaceutical Co., Ltd. (1)

13 Lilly del Caribe, Inc. (1)

14 MSN Laboratories PVT LTD (1)

15 Macleods Pharmaceuticals Limited (2)

16 Nosch Labs Pvt. Ltd@[Manufacturer of starting material (duloxetine hydrochloride)] Nosch Labs Pvt. Ltd (4)

17 Nosch Labs private limited Unit-II (1)

18 SCI Pharmtech, Inc. (1)

19 Shodhana Laboratories Limited (1)

20 Titan Laboratories Pvt. Ltd. (2)

21 Union Quimico Farmaceutica, SA (1)

22 [Starting material (duloxetine hydrochloride) manufacturer] Nosch Labs Pvt. Ltd@Nosch Labs Pvt. Ltd (1)

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01 Aging Life Science Co., Ltd. (1)

02 Dasan Pharmaceutical Co., Ltd. (1)

03 Hanseochem Co., Ltd. (1)

04 Hwanin Pharmaceutical Co., Ltd. (1)

05 Iksoo Pharmaceutical Co., Ltd. (1)

06 Ildong Pharmaceutical Co., Ltd. (1)

07 Inist ST Co., Ltd. (1)

08 Kookjeon Pharmaceutical Co., Ltd. (1)

09 Korea Biochem Pharmaceutical Co., Ltd. (1)

10 Korea Lily Co., Ltd. (2)

11 Korea Pharmaceutical Co., Ltd. (2)

12 Kyungbo Pharmaceutical Co., Ltd. (1)

13 Myungin Pharmaceutical Co., Ltd. (2)

14 Pharmapia Co., Ltd. (2)

15 Saehan Pharmaceutical Co., Ltd. (1)

16 Samo Pharmaceutical Co., Ltd. (1)

17 Sandoz Korea Co., Ltd. (1)

18 Sangjin Trading Co., Ltd. (1)

19 Sungjin Exim Co., Ltd. (1)

20 UNUST Co., Ltd. (1)

21 Unimed Pharmaceutical Co., Ltd. (1)

22 Wonpoong Pharmaceutical Co., Ltd. (3)

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01 Duloxetine hydrochloride (2)

02 duloxetine hydrochloride (26)

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01 Germany (1)

02 India (16)

03 Israel (1)

04 South Korea (6)

05 Spain (2)

06 Taiwan (1)

07 U.S.A (1)

URL Supplier Web Content
Korea Lily Co., Ltd.
2007-01-25
Number 51-3-ND
Evonik Corporation
U.S.A
Tippecanoe Laboratories16...
Saehan Pharmaceutical Co., Ltd.
2015-07-27
Number 4098-3-ND
Moehs Cantabra SL_x000D_
Spain
Poligono Industrial Reque...
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Sandoz Korea Co., Ltd.
2016-01-14
Number 4480-1-ND
Alembic Pharmaceuticals L...
India
Plot No. 842-843, TAL-Pad...
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Myungin Pharmaceutical Co., Ltd.
2018-01-16
Number 3838-4-ND(2)
Hetero Drugs Limited
India
Sy. No.213. 214&255, Bont...
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Korea Biochem Pharmaceutical Co., Ltd.
2018-06-27
2152-5-ND
Korea Biochem Pharmaceuti...
South Korea
204 Sandan-gil, Jeonui-my...
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Kyungbo Pharmaceutical Co., Ltd.
2016-11-24
1673-21-ND
Kyungbo Pharmaceutical Co...
South Korea
174, Silok-ro, Asan-si, C...
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Pharmapia Co., Ltd.
2019-04-22
Number 3838-8-ND(4)
[Starting material (dulox...
India
Sy.No.14, Gaddapotharam V...
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Unimed Pharmaceutical Co., Ltd.
2015-03-11
Number 3838-8-ND(3)
Nosch Labs Pvt. Ltd@[Manu...
India
5-5-35/33/3, Prashanthi N...
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Korea Pharmaceutical Co., Ltd.
2016-05-27
Number 6580-22-ND(1)
Titan Laboratories Pvt. L...
India
Plot No. E27/1 & E27/2, M...
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Sangjin Trading Co., Ltd.
2016-01-22
Number 6580-22-ND
Titan Laboratories Pvt. L...
India
Plot No. E27/1 & E27/2, M...
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Looking for 136434-34-9 / Duloxetine API manufacturers, exporters & distributors?

Duloxetine manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Duloxetine

Synonyms

136434-34-9, Duloxetine hcl, Cymbalta, (s)-duloxetine hydrochloride, Ariclaim, Xeristar

Cas Number

136434-34-9

Unique Ingredient Identifier (UNII)

9044SC542W

About Duloxetine

A thiophene derivative and selective NEUROTRANSMITTER UPTAKE INHIBITOR for SEROTONIN and NORADRENALINE (SNRI). It is an ANTIDEPRESSIVE AGENT and ANXIOLYTIC, and is also used for the treatment of pain in patients with DIABETES MELLITUS and FIBROMYALGIA.

Duloxetine Manufacturers

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

Duloxetine Suppliers

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

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

Duloxetine KDMF

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

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

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

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

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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