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List of Korea Drug Master Files (KDMF) for Azelastine Hydrochloride Active Pharmaceutical Ingredient submitted to the Review Authority in Korea and listed on PharmaCompass.com

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Flag Germany
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Bukwang Pharmaceutical Co., Ltd.
2008-08-29
20080829-44-C-224-06
Evonik Operations GmbH
Germany
Rodenbacher Chaussee 4 63...
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Hallym Pharmaceutical Co., Ltd.
2011-10-21
20050915-44-C-200-03(5)
Daito Pharmaceutical Co.,...
Japan
326 Yokamachi, Toyama-shi...
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Bukwang Pharmaceutical Co., Ltd.
2011-09-15
20050915-44-C-200-03(6)
DAITO Pharmaceutical Co.,...
Japan
326 Yokamachi, Toyama-shi...
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Samo Pharmaceutical Co., Ltd.
2018-03-09
20050915-44-C-200-03(8)
DAITO Pharmaceutical Co.,...
Japan
326 Yokamachi, Toyama-shi...
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Samo Pharmaceutical Co., Ltd.
2005-09-15
20050915-44-C-200-03
DAITO Pharmaceutical Co.,...
Japan
326 Yokamachi, Toyama-shi...
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Taejun Pharmaceutical Co., Ltd.
2011-08-12
20050915-44-C-200-03(1)
DAITO Pharmaceutical Co.,...
Japan
326 Yokamachi, Toyama-shi...
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Hwail Pharmaceutical Co., Ltd.
2011-08-12
20050915-44-C-200-03(2)
DAITO Pharmaceutical Co.,...
Japan
326 Yokamachi, Toyama-shi...
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Ilhwa Co., Ltd.
2011-08-05
20050915-44-C-200-03(3)
Daito Pharmaceutical Co.,...
Japan
326 Yokamachi, Toyama-shi...
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Korea Biochem Pharmaceutical Co., Ltd.
2014-06-30
20140630-44-C-331-10
Korea Biochem Pharmaceuti...
South Korea
204 Sandan-gil, Jeonui-my...
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Korea United Pharmaceutical Co., Ltd.
2005-09-30
20050930-44-C-150-04
Korea United Pharmaceutic...
South Korea
107, Gongdan-ro, Yeonseo-...
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Sungjin Exim Co., Ltd.
2017-02-15
20170215-44-C-359-11
Urquima S.A.
Spain
Arnau de Vilanova, 22-42,...
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Hwail Pharmaceutical Co., Ltd.
2013-02-14
20120919-44-C-296-08(1)
Cadila Healthcare Limited
India
Plot No.: 26 to 29 & 31, ...
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Hallym Pharmaceutical Co., Ltd.
2020-06-15
20120919-44-C-296-08(3)
Zydus Lifesciences Limite...
India
Plot No.: 26 to 29 & 31, ...
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Goodwills Co., Ltd.
2012-09-19
20120919-44-C-296-08
Zydus Lifesciences Limite...
India
Plot No.: 26 to 29 & 31, ...
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Pharmapia Co., Ltd.
2014-04-10
20120919-44-C-296-08(2)
Zydus Lifesciences Limite...
India
Plot No.: 26 to 29 & 31, ...
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  • SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SPRAY, METERED;NASAL - 0.137MG/SPRAY;0.05MG/SPRAY
  • SOLUTION/DROPS;OPHTHALMIC - 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Looking for 79307-93-0 / Azelastine Hydrochloride API manufacturers, exporters & distributors?

Azelastine Hydrochloride manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Azelastine Hydrochloride

Synonyms

Azelastine hcl, 79307-93-0, Optivar, Astelin, Allergodil, Rhinolast

Cas Number

79307-93-0

Unique Ingredient Identifier (UNII)

0L591QR10I

About Azelastine Hydrochloride

Azelastine Hydrochloride is the hydrochloride salt form of azelastine, a phthalazinone derivative with antihistaminergic activity. Azelastine hydrochloride competes with histamine for the H1 receptor, thereby diminishing the actions of histamine on effector cells and decreasing the histamine-mediated symptoms of allergic reaction, such as bronchoconstriction, vasodilation, increased capillary permeability and spasmodic contractions of gastrointestinal smooth muscle.

Azelastine Hydrochloride Manufacturers

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

Azelastine Hydrochloride Suppliers

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

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

Azelastine Hydrochloride KDMF

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

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

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

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

Azelastine Hydrochloride Manufacturers | Traders | Suppliers

Azelastine Hydrochloride Manufacturers, Traders, Suppliers 1
68

We have 6 companies offering Azelastine Hydrochloride

Get in contact with the supplier of your choice:

  1. Evonik
  2. Daito Pharmaceutical Co.,Ltd.
  3. Korea Biochem Pharm
  4. Korea United Pharm. Inc.
  5. Urquima S.A. Grupo Uriach
  6. Zydus Lifesciences
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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