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List of Drug Master Files (DMF) of Lurasidone HCl Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Metrochem API Private Limited (1)

02 Veranova (1)

03 Dr. Reddy's Laboratories (1)

04 Neuland Laboratories (1)

05 ALP Pharm (1)

06 Alembic Pharmaceuticals Limited (1)

07 Amsa Spa (1)

08 Apotex Pharmachem (1)

09 Aurobindo Pharma Limited (1)

10 Glenmark Life Sciences (1)

11 Hetero Drugs (1)

12 Hisun Pharmaceutical Nantong Co., Ltd. (1)

13 Intas Pharmaceuticals (1)

14 Jubilant Generics (1)

15 Lee Pharma (1)

16 Lupin Ltd (1)

17 MSN Laboratories (2)

18 Macleods Pharmaceuticals Limited (1)

19 Piramal Pharma Solutions (1)

20 Procos (1)

21 Raks Pharma (1)

22 Recipharm AB (1)

23 Solara Active Pharma Sciences (1)

24 Sumitomo Pharma (1)

25 Sun Pharmaceutical Industries Limited (1)

26 Teva API (1)

27 Torrent Pharmaceuticals Limited (1)

28 Unichem Laboratories Limited (1)

29 Viatris (1)

30 ZCL Chemicals Limited (1)

31 Zydus Lifesciences (1)

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01 LURASIDONE (1)

02 LURASIDONE HCL (1)

03 LURASIDONE HYDROCHLORIDE (28)

04 LURASIDONE HYDROCHLORIDE [ROUTE CODE - LN"] (1)

05 SM-13496 (1)

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01 Canada (1)

02 China (2)

03 India (21)

04 Israel (1)

05 Italy (2)

06 Japan (1)

07 Sweden (1)

08 U.S.A (3)

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01 Active (31)

02 Inactive (1)

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01 Complete (20)

02 Blank (12)

34255
Active
2020-01-31
Complete
2020-04-07
2019-12-03
II
URL Supplier Web Content
27584
Active
2013-12-05
Complete
2017-05-11
2016-08-12
II
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URL Supplier Web Content
27898
Active
2014-04-30
Complete
2014-06-24
2014-01-24
II
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URL Supplier Web Content
27452
Active
2013-09-20
Complete
2014-04-03
2014-01-09
II
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URL Supplier Web Content
27963
Active
2014-04-11
Complete
2014-07-07
2014-04-29
II
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URL Supplier Web Content
27570
Active
2013-09-30
Complete
2014-07-07
2014-04-28
II
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URL Supplier Web Content
16059
Active
2002-07-15
N/A
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Looking for 367514-88-3 / Lurasidone API manufacturers, exporters & distributors?

Lurasidone manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Lurasidone

Synonyms

Lurasidone hcl, 367514-88-3, Latuda, Sm-13496, Lurasidone hydrochloride [usan], Sm 13496

Cas Number

367514-88-3

Unique Ingredient Identifier (UNII)

O0P4I5851I

About Lurasidone

A thiazole derivative and atypical ANTIPSYCHOTIC AGENT that functions as a DOPAMINE D2 RECEPTOR ANTAGONIST; SEROTONIN 5-HT2 RECEPTOR ANTAGONIST, serotonin 5-HT7 receptor antagonist, and antagonist of the adrenergic 2A and 2C receptors, as well as a partial SEROTONIN 5-HT1A RECEPTOR AGONIST. It is used in the treatment of SCHIZOPHRENIA and BIPOLAR DISORDER.

Lurasidone HCl Manufacturers

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

Lurasidone HCl Suppliers

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

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

Lurasidone HCl USDMF

A Lurasidone HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Lurasidone HCl active pharmaceutical ingredient (API) in detail. Different forms of Lurasidone HCl DMFs exist exist since differing nations have different regulations, such as Lurasidone HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Lurasidone HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Lurasidone HCl USDMF includes data on Lurasidone HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lurasidone HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Lurasidone HCl suppliers with USDMF on PharmaCompass.

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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