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

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Samo Pharmaceutical Co., Ltd.
2020-11-03
20201103-211-J-782
INKE S.A.
Spain
C/Argent 1, Area Industri...
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AstraZeneca Korea Co., Ltd.
2022-09-08
20220908-211-J-1360
PCAS Finland Oy@AstraZene...
France
Messukentankatu 8, 20210 ...
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AstraZeneca Korea Co., Ltd.
2021-07-05
20210705-211-J-1053
PCAS Finland Oy@AstraZene...
France
Messukentankatu 8, 20210 ...
Seqens Company Banner

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Aging Life Science Co., Ltd.
2022-01-12
20220112-211-J-1206
Harman Finochem Limited
India
Plot No. E-7, E-8 & E-9, ...
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Masung LS Co., Ltd.
2020-06-03
20200603-210-J-438
Suven Pharmaceuticals Lim...
India
Plot Nos. 262 to 271, IDA...
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  • TABLET;ORAL - 1MG
  • TABLET;ORAL - 2MG
  • INJECTABLE;INJECTION - 0.2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • POWDER;INHALATION - 15.6MCG/INH
  • POWDER;INHALATION - 15.6MCG/INH;27.5MCG/INH
  • SOLUTION;INHALATION - 25MCG/ML

Looking for 596-51-0 / Glycopyrronium Bromide API manufacturers, exporters & distributors?

Glycopyrronium Bromide manufacturers, exporters & distributors 1

15

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

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

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

API | Excipient name

Glycopyrronium Bromide

Synonyms

596-51-0, Glycopyrrolate bromide, Robinul, Gastrodyn, Nodapton, Tarodyl

Cas Number

596-51-0

About Glycopyrronium Bromide

A muscarinic antagonist used as an antispasmodic, in some disorders of the gastrointestinal tract, and to reduce salivation with some anesthetics.

Glycopyrronium Bromide Manufacturers

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

Glycopyrronium Bromide Suppliers

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

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

Glycopyrronium Bromide KDMF

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

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

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

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

Glycopyrronium Bromide Manufacturers | Traders | Suppliers

Glycopyrronium Bromide Manufacturers, Traders, Suppliers 1
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We have 4 companies offering Glycopyrronium Bromide

Get in contact with the supplier of your choice:

  1. Inke S.A
  2. PCAS
  3. Harman Finochem
  4. Suven Pharmaceuticals
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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