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

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01 Boehringer Ingelheim Pharma GmbH & Co. K.G. (1)

02 DNP Fine Chemical Utsunomiya Co., Ltd. (2)

03 Daito Co., Ltd. (1)

04 Daiwa Pharmaceutical Co., Ltd. (2)

05 Hubei Haosun Pharmaceutical Co. , Ltd. (1)

06 IcromS. r. l. (1)

07 JEIL PHARMACEUTICAL CO. , LTD. (4)

08 Permakem Asia Co., Ltd. (1)

09 Pharmacostech CO. ,LTD (2)

10 Sanyo Chemical Research Institute Co., Ltd. (1)

11 UK Chemipharm Co. , Ltd. (1)

12 YUIL PHARM TECH. C.O. , LTD. (1)

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01 Epinastine Hydrochloride (2)

02 Epinastine hydrochloride (8)

03 Epinastine hydrochloride "Sanyo" (1)

04 Epinastine hydrochloride (C) (production only) (1)

05 Epinastine hydrochloride (for manufacturing use only) (1)

06 Epinastine hydrochloride (production only) (2)

07 epinastine hydrochloride (3)

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01 China (1)

02 Egypt (1)

03 Gabon (1)

04 Germany (1)

05 India (1)

06 Italy (1)

07 Japan (6)

08 South Korea (6)

URL Supplier Web Content
224MF10100
Binger Strasse 173,55216 Ingelheim ...
2017-10-06
2012-05-23
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226MF10049
2-3-5 Shimookui, Toyama City, Toyam...
2014-02-27
2014-02-27
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305MF10001
1062-8 Honjo, Nishikata-cho, Tochig...
2023-10-04
2023-01-11
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221MF10218
1062-8 Honjo, Nishikata-cho, Tochig...
2023-06-14
2009-10-07
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227MF10217
No. 20 Juxian Road, Gedian Economic...
2015-08-31
2015-08-31
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226MF10231
Via Delle Arti 33, 20863 Concorezzo...
2020-06-11
2014-12-08
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302MF10008
47, Jeyakdanji-ro, Hyangnam-eup, Hw...
2020-01-10
2020-01-10
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302MF10108
47, Jeyakdanji-ro, Hyangnam-eup, Hw...
2020-09-08
2020-09-08
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229MF10196
2-3-5 Shimookui, Toyama City, Toyam...
2017-11-07
2017-11-07
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303MF10009
3, Mulmi-gil, Iwol-myeon, Jincheon-...
2021-01-20
2021-01-20
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Looking for 80012-44-8 / Epinastine Hydrochloride API manufacturers, exporters & distributors?

Epinastine Hydrochloride manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Epinastine Hydrochloride

Synonyms

Epinastine hcl, 108929-04-0, Alesion, Elestat, Wal-801cl, 80012-44-8

Cas Number

80012-44-8

Unique Ingredient Identifier (UNII)

GFM415S5XL

About Epinastine Hydrochloride

Epinastine Hydrochloride is an histamine H1 receptor antagonist without sedative activity. Epinastine hydrochloride blocks the histamine H1 receptor and inhibits the release of histamine from mast cells. This prevents the typical allergic symptoms that are caused by histamine activity on capillaries, skin, mucous membranes, and on gastrointestinal and bronchial smooth muscles. Typical histamine activities include vasodilation, bronchoconstriction, increased vascular permeability, pain, itching, and spasmodic contractions of gastrointestinal smooth muscles. Epinastine also has affinity for the histamine H2, 5-HT2, and the alpha-1, alpha-2 adrenergic receptors.

Epinastine Hydrochloride Manufacturers

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

Epinastine Hydrochloride Suppliers

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

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

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

Epinastine Hydrochloride Manufacturers | Traders | Suppliers

Epinastine Hydrochloride 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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