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List of Drug Master Files (JDMF) for 08J Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

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01 Wavelength Enterprises Ltd (1)

02 Cambrex Profarmaco Milano S. r. l. (1)

03 F. I. S. Fabrica Italiana Sintetici S. p. A. (1)

04 SUN PHARMACEUTICAL INDUSTRIES LIMITED. (1)

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01 Midazolam (4)

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01 France (1)

02 India (1)

03 Italy (1)

04 U.S.A (1)

URL Supplier Web Content
223MF10029
Via Curiel 34, 20067 Paulo, Milano,...
2016-10-31
2011-02-25
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URL Supplier Web Content
229MF10108
Viale Milano 26 36075 Montecchio Ma...
2017-06-21
2017-06-21
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URL Supplier Web Content
219MF10137
SUN HOUSE, Plot No. 201 B/1, Wester...
2012-08-13
2007-04-18
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Looking for 59467-70-8 / Midazolam API manufacturers, exporters & distributors?

Midazolam manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Midazolam

Synonyms

Dormicum, 59467-70-8, Versed, 8-chloro-6-(2-fluorophenyl)-1-methyl-4h-imidazo[1,5-a][1,4]benzodiazepine, Midazolamum, Buccolam

Cas Number

59467-70-8

Unique Ingredient Identifier (UNII)

R60L0SM5BC

About Midazolam

A short-acting hypnotic-sedative drug with anxiolytic and amnestic properties. It is used in dentistry, cardiac surgery, endoscopic procedures, as preanesthetic medication, and as an adjunct to local anesthesia. The short duration and cardiorespiratory stability makes it useful in poor-risk, elderly, and cardiac patients. It is water-soluble at pH less than 4 and lipid-soluble at physiological pH.

08J Manufacturers

A 08J manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 08J, including repackagers and relabelers. The FDA regulates 08J manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 08J 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 08J manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

08J Suppliers

A 08J supplier is an individual or a company that provides 08J active pharmaceutical ingredient (API) or 08J finished formulations upon request. The 08J suppliers may include 08J API manufacturers, exporters, distributors and traders.

click here to find a list of 08J suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

08J JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The 08J Drug Master File in Japan (08J JDMF) empowers 08J API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the 08J JDMF during the approval evaluation for pharmaceutical products. At the time of 08J JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of 08J suppliers with JDMF on PharmaCompass.

08J Manufacturers | Traders | Suppliers

08J Manufacturers, Traders, Suppliers 1
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We have 4 companies offering 08J

Get in contact with the supplier of your choice:

  1. Seqens
  2. Cambrex Corporation
  3. F.I.S. Fabbrica Italiana Sintetici
  4. RANBAXY LABORATORIES LIMITED
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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