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

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01 JSC OlainFarm (1)

02 Megafine Pharma (P) Ltd. (1)

03 Alembic Pharmaceuticals Limited (API Unit-1) (2)

04 Hetero Drugs Limited (Unit-IX) (8)

05 Lundbeck Pharmaceuticals Italy SPA (1)

06 Olon SpA (2)

07 PLIVA Croatia Ltd (3)

08 Procos SpA (1)

09 Unichem Laboratories Ltd., (2)

10 ZCL Chemicals Limited (4)

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01 Ace Biopharm Co., Ltd. (1)

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

03 Base Farm Co., Ltd. (1)

04 Ecell Bio Co., Ltd. (2)

05 Eltech Pharmachem Co., Ltd. (1)

06 Hansol Pharma Co., Ltd. (1)

07 Hwail Pharmaceutical Co., Ltd. (1)

08 IMCD Korea Co., Ltd. (1)

09 Korea Lundbeck Co., Ltd. (1)

10 Korea Pharmaceutical Co., Ltd. (1)

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

12 Leesung International Co., Ltd. (1)

13 Myungin Pharmaceutical Co., Ltd. (1)

14 Northeast Farm Korea Co., Ltd. (1)

15 Pharmapia Co., Ltd. (2)

16 Samo Pharmaceutical Co., Ltd. (1)

17 Sangjin Trading Co., Ltd. (1)

18 Seongui Bio Co., Ltd. (1)

19 Sungjin Exim Co., Ltd. (1)

20 Sungwoo Chemical Co., Ltd. (1)

21 Wonpoong Pharmaceutical Co., Ltd. (1)

22 Youngjin Pharmaceutical Co., Ltd. (2)

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01 Memantine hydrochloride (25)

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01 Croatia (3)

02 Denmark (1)

03 India (17)

04 Italy (3)

05 Latvia (1)

Eltech Pharmachem Co., Ltd.
2020-05-22
20200522-209-J-377
JSC OlainFarm
Latvia
5, Rupnicu Street, Olaine...
IMCD Korea Co., Ltd.
2020-09-04
20200904-209-J-373
Megafine Pharma (P) Ltd.
India
Plot No. 1 to 5, 31 to 35...
Megafine Pharma CB

RDD 2024

Not Confirmed

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Youngjin Pharmaceutical Co., Ltd.
2020-08-20
20190326-209-J-197(1)
Alembic Pharmaceuticals L...
India
AT-Panelav, Tal-Halol, Ci...
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Ecell Bio Co., Ltd.
2023-05-26
20181018-209-J-124(7)
Hetero Drugs Limited (Uni...
India
Plot No. 1, Hetero Infras...
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Base Farm Co., Ltd.
2021-07-11
20210303-209-J-853(1)
Olon SpA
Italy
Via Milano, 186 20024 gar...
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Sangjin Trading Co., Ltd.
2021-03-03
20210303-209-J-853
Olon SpA
Italy
Via Milano, 186 20024 gar...
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Sungjin Exim Co., Ltd.
2021-10-05
20211005-209-J-1116
Procos SpA
Italy
Via Matteotti, 249 - 2806...
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Ace Biopharm Co., Ltd.
2021-05-18
20210518-209-J-917
Unichem Laboratories Ltd....
India
Plot No. 197, Sector-1, P...
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Northeast Farm Korea Co., Ltd.
2022-07-26
20210518-209-J-917(1)
Unichem Laboratories Ltd....
India
Plot No. 197, Sector-1, P...
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Pharmapia Co., Ltd.
2022-01-13
20200304-209-J-395(3)
ZCL Chemicals Limited
India
3102/B GIDC, Industrial E...
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Looking for 41100-52-1 / Memantine Hydrochloride API manufacturers, exporters & distributors?

Memantine Hydrochloride manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Memantine Hydrochloride

Synonyms

41100-52-1, Memantine hcl, Namenda, 3,5-dimethyl-1-adamantanamine hydrochloride, 3,5-dimethyladamantan-1-amine hydrochloride, Akatinol

Cas Number

41100-52-1

Unique Ingredient Identifier (UNII)

JY0WD0UA60

About Memantine Hydrochloride

AMANTADINE derivative that has some dopaminergic effects. It has been proposed as an antiparkinson agent.

Ebixa Manufacturers

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

Ebixa Suppliers

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

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

Ebixa KDMF

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

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

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

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

Ebixa Manufacturers | Traders | Suppliers

Ebixa 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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