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

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Flag Czech Republic
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Korea Pharmaceutical Co., Ltd.
2021-03-09
20200515-209-J-477(2)
Farmak, as
Czech Republic
Na vlcinci 16/3, Klastern...
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Hwanin Pharmaceutical Co., Ltd.
2020-09-04
20200515-209-J-477(1)
Farmak, as
Czech Republic
Na vlcinci 16/3, Klastern...
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Sungjin Exim Co., Ltd.
2020-05-15
20200515-209-J-477
Farmak, as
Czech Republic
Na vlcinci 16/3, Klastern...
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Handok Co., Ltd.
2021-03-22
20210322-209-J-901
Sanofi Chimie
France
45, chemin de Météline ...
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Hwanin Pharmaceutical Co., Ltd.
2023-02-03
20210727-209-J-1081(2)
Centaur Pharmaceuticals P...
India
Plot No. 75, 76 & 76/1, C...
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Hanmi Pharmaceutical Co., Ltd.
2021-07-27
20210727-209-J-1081
Centaur Pharmaceuticals P...
India
Plot No. 75, 76 & 76/1, C...
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Hana Pharmaceutical Co., Ltd.
2024-01-05
20210727-209-J-1081(A)
Centaur Pharmaceuticals P...
India
Plot no. 75,76 & 76/1, Ch...
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Hana Pharmaceutical Co., Ltd.
2022-01-12
20210727-209-J-1081(1)
Centaur Pharmaceuticals P...
India
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Korea Pharma Co., Ltd.
2021-05-13
20210513-209-J-986
Mylan Laboratories Limite...
India
Survey No. 10, Gaddapotha...
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  • TABLET;ORAL - 10MG
  • TABLET;ORAL - 5MG
  • TABLET, EXTENDED RELEASE;ORAL - 12.5MG
  • TABLET, EXTENDED RELEASE;ORAL - 6.25MG
  • SPRAY, METERED;ORAL - 5MG/SPRAY
  • TABLET;SUBLINGUAL - 1.75MG
  • TABLET;SUBLINGUAL - 3.5MG

Looking for 99294-93-6 / Zolpidem Tartrate API manufacturers, exporters & distributors?

Zolpidem Tartrate manufacturers, exporters & distributors 1

30

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

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

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

API | Excipient name

Zolpidem Tartrate

Synonyms

99294-93-6, Zolpidem tartarate, Schembl40721, Mls001401453, N,n-dimethyl-2-(6-methyl-2-(p-tolyl)imidazo[1,2-a]pyridin-3-yl)acetamide 2,3-dihydroxysuccinate, Chembl1723343

Cas Number

99294-93-6

About Zolpidem Tartrate

An imidazopyridine derivative and short-acting GABA-A receptor agonist that is used for the treatment of INSOMNIA.

Zolpidem Tartrate Manufacturers

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

Zolpidem Tartrate Suppliers

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

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

Zolpidem Tartrate KDMF

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

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

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

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

Zolpidem Tartrate Manufacturers | Traders | Suppliers

Zolpidem Tartrate Manufacturers, Traders, Suppliers 1
67

We have 4 companies offering Zolpidem Tartrate

Get in contact with the supplier of your choice:

  1. FARMAK, a.s
  2. EUROAPI
  3. Centaur Pharmaceuticals
  4. Viatris
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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