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

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01 Curia Italy S. r. l. (1)

02 Teva Czech Industries s. r. o. (3)

03 CONCORD BIOTECH LIMITED. (1)

04 Hangzhou Zhongmei Huadong Pharmaceutical Co. , Ltd. (1)

05 Joyang Laboratories (1)

06 North China Pharmaceutical Huasheng Co. , Ltd. (1)

07 Novartis Pharma AG (1)

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01 Ciclosporin JP (1)

02 Cyclosporine (4)

03 Cyclosporine (2)

04 Japanese Pharmacopoeia cyclosporine (1)

05 Japanese Pharmacopoeia cyclosporine (production only) (1)

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01 China (3)

02 India (1)

03 Israel (3)

04 Switzerland (1)

05 U.S.A (1)

URL Supplier Web Content
218MF10617
Via del Vecchio Politecnico n. 9, 2...
2006-11-15
2006-07-03
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305MF10110
Ostravska 305/29, Komarov, 747 70 O...
2023-09-20
2023-09-20
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305MF10106
Ostravska 305/29, Komarov, 747 70 O...
2023-09-06
2023-09-06
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220MF10190
Ostravska 29/305,747 70 Opava-Komar...
2016-03-29
2008-08-18
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226MF10056
1482-1486, Trasad Road, Dholka, Dis...
2021-08-16
2014-03-06
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217MF11017
Xiangfu Bridge, No. 866 Morganshan ...
2014-09-30
2005-11-21
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302MF10130
No. 9, Haidu North Road, Sheyang Ec...
2020-10-21
2020-10-21
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305MF10032
No. 8 Yangzi Road, Shijiazhuang, Ec...
2023-03-07
2023-03-07
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222MF10083
Lichtstrasse 35, CH-4056 Basel, Swi...
2010-03-09
2010-03-09
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Looking for 59865-13-3 / Cyclosporine API manufacturers, exporters & distributors?

Cyclosporine manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Cyclosporine

Synonyms

Ciclosporin, 59865-13-3, Cyclosporine a, Sandimmune, Neoral, Sandimmun

Cas Number

59865-13-3

Unique Ingredient Identifier (UNII)

83HN0GTJ6D

About Cyclosporine

A cyclic undecapeptide from an extract of soil fungi. It is a powerful immunosupressant with a specific action on T-lymphocytes. It is used for the prophylaxis of graft rejection in organ and tissue transplantation. (From Martindale, The Extra Pharmacopoeia, 30th ed).

Restasis Manufacturers

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

Restasis Suppliers

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

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

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

Restasis Manufacturers | Traders | Suppliers

Restasis Manufacturers, Traders, Suppliers 1
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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