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

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01 ESTECHPHARMA CO. , LTD. (2)

02 KYUNG DONG PHARM. C.O. , LTD. (2)

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

04 Permakem Asia Co., Ltd. (1)

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01 Hydrochloric acid roxatidine acetate (1)

02 Roxatidine Acetate Hydrochloride (1)

03 Roxatidine acetate hydrochloride (3)

04 Roxatidine acetate hydrochloride (prepared only) (1)

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01 Japan (2)

02 South Korea (4)

URL Supplier Web Content
218MF10789
25, Barangongdan-ro, Hyangnam-eup, ...
2014-04-02
2006-09-22
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228MF10110
25, Barangongdan-ro, Hyangnam-eup, ...
2016-06-08
2016-06-08
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226MF10169
9FL, KyungDong Pharm Bldg, 1926, Na...
2014-09-01
2014-09-01
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301MF10100
3F SMART-K Bldg. B, 26, Gwacheon-da...
2019-11-27
2019-11-27
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217MF10722
1-10-11 Nihonbashi Horidome-cho, Ch...
2009-01-13
2005-10-07
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219MF10219
3-10-4 Nihonbashi Ningyocho, Chuo-k...
2007-07-06
2007-07-06
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Looking for 93793-83-0 / Roxatidine Acetate Hydrochloride API manufacturers, exporters & distributors?

Roxatidine Acetate Hydrochloride manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Roxatidine Acetate Hydrochloride

Synonyms

93793-83-0, Roxatidine acetate hcl, Altat, Gastralgin, Hoe 760, Tzu-0460

Cas Number

93793-83-0

Unique Ingredient Identifier (UNII)

60426GOR1E

Roxatidine Acetate Hydrochloride Manufacturers

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

Roxatidine Acetate Hydrochloride Suppliers

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

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

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

Roxatidine Acetate Hydrochloride Manufacturers | Traders | Suppliers

Roxatidine Acetate Hydrochloride Manufacturers, Traders, Suppliers 1
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We have 4 companies offering Roxatidine Acetate Hydrochloride

Get in contact with the supplier of your choice:

  1. Estechpharma
  2. KyungDong Pharm
  3. Permachem Asia, Ltd
  4. Yuki Gosei Kogyo Co., Ltd.
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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