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

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01 PCAS (1)

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01 Samo Pharmaceutical Co., Ltd. (1)

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01 Oxybutynin hydrochloride (1)

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01 France (1)

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Samo Pharmaceutical Co., Ltd.
2022-01-13
20220113-209-J-1211
PCAS
France
19 route de Meulan, LIMAY...
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Looking for 1508-65-2 / Oxybutynin Hydrochloride API manufacturers, exporters & distributors?

Oxybutynin Hydrochloride manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Oxybutynin Hydrochloride

Synonyms

1508-65-2, Oxybutynin hcl, Tropax, Oxybutynin (chloride), Ditropan xl, Pollakisu

Cas Number

1508-65-2

Unique Ingredient Identifier (UNII)

L9F3D9RENQ

About Oxybutynin Hydrochloride

Oxybutynin Chloride is the chloride salt form of oxybutynin, a tertiary amine and anticholinergic agent with antispasmodic activity. Oxybutynin chloride exerts its antimuscarinic effect on bladder smooth muscle by blocking muscarinic receptors in smooth muscle, thereby inhibiting acetylcholine binding. This results in a relaxation of bladder smooth muscle, a reduction of involuntary muscle contractions and delays the initial desire to void.

Oxybutynin Chloride Manufacturers

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

Oxybutynin Chloride Suppliers

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

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

Oxybutynin Chloride KDMF

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

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

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

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

Oxybutynin Chloride Manufacturers | Traders | Suppliers

Oxybutynin Chloride Manufacturers, Traders, Suppliers 1
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We have 1 companies offering Oxybutynin Chloride

Get in contact with the supplier of your choice:

  1. PCAS
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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