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List of Korea Drug Master Files (KDMF) for Alzac 20 Active Pharmaceutical Ingredient submitted to the Review Authority in Korea and listed on PharmaCompass.com

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SERVICES
Flag Finland
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Pharma Science Korea Co., Ltd.
2014-10-14
20141014-51-C-327-10
Fermion Oy
Finland
Orioninkatu 2, 10900 Hank...
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Samo Pharmaceutical Co., Ltd.
2005-08-31
20050831-51-C-171-02
Apotechnia S.A.
Spain
Ctra De Zeneta, 149-Apdo....
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Samo Pharmaceutical Co., Ltd.
2005-09-30
20050930-51-C-170-05
Asia Chemical Industries ...
Israel
Neot-Hovav Eco-Industrial...
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Shinpoong Pharmaceutical Co., Ltd.
2011-07-29
20050930-51-C-170-05(1)
Assia Chemical Industries...
Israel
Neot-Hovav Eco-Industrial...
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Pharma Science Korea Co., Ltd.
2023-12-27
20231227-51-C-405-12
Apitoria Pharma Private L...
India
Sy. No.10 & 13, Gaddapoth...
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Korea Lily Co., Ltd.
2009-08-21
20090821-51-C-262-09
Siegfried Ltd
Switzerland
Untere Bruhlstrasse 4 CH-...
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Myungin Pharmaceutical Co., Ltd.
2012-06-26
20050831-51-C-175-04(7)
Union Quimico Farmaceutic...
Spain
Union quimico farmaceutic...
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Unimed Pharmaceutical Co., Ltd.
2012-06-25
20050831-51-C-175-04(8)
UNION QUIMICO FARMACEUTIC...
Spain
Poligon Industrial El Pla...
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Daewon Pharmaceutical Co., Ltd.
2015-09-15
20050831-51-C-175-04(12)
Union quimico farmaceutic...
Spain
Union quimico farmaceutic...
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Sungjin Exim Co., Ltd.
2005-08-31
20050831-51-C-175-04
Union quimico farmaceutic...
Spain
Union quimico farmaceutic...
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Mpeak Korea Co., Ltd.
2017-12-08
20050831-51-C-175-04(14)
Union Quimico Farmaceutic...
Spain
Poli Industrial E1 Pla Av...
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Korea United Pharmaceutical Co., Ltd.
2012-06-01
20050831-51-C-175-04(6)
Union Quimico Farmaceutic...
Spain
Union Quimico Farmaceutic...
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IMCD Korea Co., Ltd.
2012-11-08
20050831-51-C-175-04(9)
Union Quimico Farmaceutic...
Spain
Poli Industrial El Pla Av...
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Daehan New Farm Co., Ltd.
2016-04-19
20050831-51-C-175-04(13)
Union Quimico Farmaceutic...
Spain
Poli Industrial E1 Pla Av...
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Hansol Pharma Co., Ltd.
2014-09-24
20050831-51-C-175-04(11)
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Spain
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Binex Co., Ltd.
2012-04-13
20050831-51-C-175-04(5)
Union Quimico Farmaceutic...
Spain
Poli Industrial El Pla Av...
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Alvogen Korea Co., Ltd.
2012-03-23
20050831-51-C-175-04(2)
UNION QUIMICOFARMACEUTICA...
Spain
Poligon Industrial El Pla...
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Sampoong Pharmachem Co., Ltd.
2013-06-04
20050831-51-C-175-04(10)
Union Quimico Farmaceutic...
Spain
Poligon Industrial El Pla...
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Anguk Pharmaceutical Co., Ltd.
2012-03-09
20050831-51-C-175-04(4)
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Spain
Poli Industrial El Pla Av...
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Seoul Pharmaceutical Co., Ltd.
2012-03-09
20050831-51-C-175-04(3)
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Spain
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Bahnsen Co., Ltd.
2018-06-25
20050831-51-C-175-04(15)
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Hwail Pharmaceutical Co., Ltd.
2012-10-25
20081031-51-C-246-08(1)
Cadila Pharmaceuticals Li...
India
294,GIDC Industrial Estat...
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Pharmapia Co., Ltd.
2016-03-30
20081031-51-C-246-08(4)
Cadila Pharmaceutical Ltd...
India
294, GIDC Industrial Esta...
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Narsha Farm Co., Ltd.
2020-01-30
20081031-51-C-246-08(A)
Cadila Pharmaceuticals Li...
India
294, GIDC Industrial Esta...
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Ace Biopharm Co., Ltd.
2015-06-26
20081031-51-C-246-08(2)
Cadila Pharmaceuticals Li...
India
294,GIDC Industrial Estat...
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Aging Life Science Co., Ltd.
2008-10-31
20081031-51-C-246-08
Cadila Pharmaceuticals Li...
India
294, GIDC Industrial Esta...
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Hiple Co., Ltd.
2015-11-12
20081031-51-C-246-08(3)
Cadila Pharmaceuticals Li...
India
294, GIDC Industrial Esta...
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Bahnsen Co., Ltd.
2018-06-25
20081031-51-C-246-08(8)
Cadila Pharmaceuticals Li...
China
294, GIDC Industrial Esta...
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Daehan New Farm Co., Ltd.
2018-01-16
20081031-51-C-246-08(6)
Cadila Pharmaceuticals Li...
India
294, GIDC Industrial Esta...
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  • CAPSULE;ORAL - EQ 10MG BASE
  • CAPSULE;ORAL - EQ 20MG BASE
  • CAPSULE;ORAL - EQ 40MG BASE
  • TABLET;ORAL - EQ 60MG BASE
  • CAPSULE, DELAYED REL PELLETS;ORAL - EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Looking for 56296-78-7 / Fluoxetine API manufacturers, exporters & distributors?

Fluoxetine manufacturers, exporters & distributors 1

49

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

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

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

API | Excipient name

Fluoxetine

Synonyms

56296-78-7, Fluoxetine hcl, Prozac, 59333-67-4, Sarafem, Fluoxeren

Cas Number

56296-78-7

Unique Ingredient Identifier (UNII)

I9W7N6B1KJ

About Fluoxetine

The first highly specific serotonin uptake inhibitor. It is used as an antidepressant and often has a more acceptable side-effects profile than traditional antidepressants.

Alzac 20 Manufacturers

A Alzac 20 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alzac 20, including repackagers and relabelers. The FDA regulates Alzac 20 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alzac 20 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 Alzac 20 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Alzac 20 Suppliers

A Alzac 20 supplier is an individual or a company that provides Alzac 20 active pharmaceutical ingredient (API) or Alzac 20 finished formulations upon request. The Alzac 20 suppliers may include Alzac 20 API manufacturers, exporters, distributors and traders.

click here to find a list of Alzac 20 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Alzac 20 KDMF

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

Pharmaceutical companies submit a Alzac 20 Drug Master File in Korea (Alzac 20 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Alzac 20. The MFDS reviews the Alzac 20 KDMF as part of the drug registration process and uses the information provided in the Alzac 20 KDMF to evaluate the safety and efficacy of the drug.

After submitting a Alzac 20 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 Alzac 20 API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Alzac 20 suppliers with KDMF on PharmaCompass.

Alzac 20 Manufacturers | Traders | Suppliers

Alzac 20 Manufacturers, Traders, Suppliers 1
27

We have 7 companies offering Alzac 20

Get in contact with the supplier of your choice:

  1. Fermion Oy
  2. APOTECNIA SA
  3. Assia Chemical Industries Ltd
  4. Aurobindo Pharma Limited
  5. Siegfried AG
  6. UQUIFA
  7. 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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