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List of Drug Master Files (JDMF) for Duloxetine Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

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01 MOEHS IBERICA, S. L. (1)

02 Assia Chemical Industries Ltd. (1)

03 ESTECHPHARMA CO. , LTD. (1)

04 Fuji Chemical Industry Co., Ltd. (1)

05 HANMI FINE CHEMICAL CO. , LTD. (1)

06 HETERO DRUGS LIMITED. (2)

07 INIST ST CO. , LTD. (1)

08 LUPIN LIMITED. (1)

09 MSN Laboratories Private Limited. (1)

10 Organic Synthetic Pharmaceutical Industry Co., Ltd. (1)

11 SCI Pharmtech, Inc. (1)

12 UBE Co., Ltd. (1)

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01 Duloxetine Hydrochloride (8)

02 Duloxetine Hydrochloride (for manufacturing use only) (1)

03 Duloxetine hydrochloride (2)

04 Duloxetine hydrochloride "K" (1)

05 Duloxetine hydrochloride "Teva" (1)

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01 India (4)

02 Israel (1)

03 Japan (3)

04 South Korea (3)

05 Spain (1)

06 Taiwan (1)

URL Supplier Web Content
302MF10024
Neot-Hovav Eco-Industrial Park, Eme...
2020-02-06
2020-02-06
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302MF10002
25, Barangongdan-ro, Hyangnam-eup, ...
2020-01-07
2020-01-07
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305MF10047
55 Yokohoonji, Kamiichi-cho, Nakash...
2023-04-05
2023-04-05
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301MF10085
57, Gyeongje-ro, Siheung-si, Gyeong...
2019-11-27
2019-10-25
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302MF10022
7-2-A2, Hetero Corporate, Industria...
2020-02-06
2020-02-06
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302MF10025
Kalpataru Inspire, 3rd Floor, Off W...
2020-11-18
2020-02-06
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229MF10088
Plot No: C-24, Sanath Nagar Industr...
2022-11-16
2017-04-26
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302MF10003
96, 1978 Kogushi, Ube City, Yamaguc...
2020-01-07
2020-01-07
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302MF10015
3-10-4 Nihonbashi Ningyocho, Chuo-k...
2020-01-27
2020-01-27
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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 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 Duloxetine Drug Master File in Japan (Duloxetine JDMF) empowers Duloxetine 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 Duloxetine JDMF during the approval evaluation for pharmaceutical products. At the time of Duloxetine 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 Duloxetine suppliers with JDMF on PharmaCompass.

Duloxetine Manufacturers | Traders | Suppliers

Duloxetine 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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