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

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01 Biocon Biologics Limited (1)

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01 Insulin glargine (gene recombination) (1)

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01 India (1)

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226MF10213
Biocon House, Ground Floor, Tower-3...
2019-01-24
2014-11-17
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Looking for / Insulin Glargine API manufacturers, exporters & distributors?

Insulin Glargine manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Insulin Glargine

Synonyms

Gtpl7572, Hoe901, Hoe-901

About Insulin Glargine

A recombinant LONG ACTING INSULIN and HYPOGLYCEMIC AGENT that is used to manage BLOOD GLUCOSE in patients with DIABETES MELLITUS.

Insulin Glargine Manufacturers

A Insulin Glargine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Insulin Glargine, including repackagers and relabelers. The FDA regulates Insulin Glargine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Insulin Glargine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

Insulin Glargine Suppliers

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

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

Insulin Glargine 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 Insulin Glargine Drug Master File in Japan (Insulin Glargine JDMF) empowers Insulin Glargine 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 Insulin Glargine JDMF during the approval evaluation for pharmaceutical products. At the time of Insulin Glargine 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 Insulin Glargine suppliers with JDMF on PharmaCompass.

Insulin Glargine Manufacturers | Traders | Suppliers

Insulin Glargine Manufacturers, Traders, Suppliers 1
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We have 1 companies offering Insulin Glargine

Get in contact with the supplier of your choice:

  1. Biocon
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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