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

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01 Aspen API (1)

02 Megafine Pharma (P) Limited (1)

03 Medichem S.A (1)

04 Alembic Pharmaceuticals Limited (1)

05 CHEMO IBERICA SA (1)

06 Hisamitsu Pharmaceutical Co., Inc. (1)

07 Lupin Ltd (1)

08 MSN Laboratories (2)

09 Olon S.p.A (1)

10 Sigmapharm Laboratories, LLC (1)

11 Signa S.A. de C.V. (1)

12 Sun Pharmaceutical Industries Limited (1)

13 Viatris (1)

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01 ASENAPINE MALEATE (7)

02 ASENAPINE MALEATE (MICRONIZED) (1)

03 ASENAPINE MALEATE (NON-STERILE DRUG SUBSTANCE) (1)

04 ASENAPINE MALEATE AMORPHOUS (31.2%) PREMIX (1)

05 ASENAPINE MALEATE [ROUTE CODE "AOI"] (1)

06 ASENAPINE MALEATE [ROUTE CODE AN] (1)

07 HP-3070 TRANSDERMAL SYSTEM (1)

08 MED-200056/E (1)

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01 India (6)

02 Italy (1)

03 Japan (1)

04 Mexico (1)

05 Netherlands (1)

06 Spain (2)

07 U.S.A (2)

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01 Active (11)

02 Inactive (3)

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01 Complete (8)

02 Blank (6)

27292
Active
2013-06-30
Complete
2013-08-28
2013-07-30
II
Megafine Pharma CB

CPhI Japan

Not Confirmed

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27194
Active
2013-07-04
Complete
2013-09-19
2013-08-08
II
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URL Supplier Web Content
26973
Active
2013-03-23
Complete
2013-11-12
2013-06-12
II
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URL Supplier Web Content
26785
Active
2013-03-08
Complete
2013-10-09
2013-05-24
II
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URL Supplier Web Content
26104
Active
2012-05-30
N/A
II
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27300
Active
2013-08-08
Complete
2013-09-22
2013-08-13
II
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27185
Active
2013-07-17
Complete
2013-10-01
2013-06-25
II
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URL Supplier Web Content
27086
Active
2013-05-17
Complete
2013-09-14
2013-05-13
II
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Looking for 85650-56-2 / Asenapine Maleate API manufacturers, exporters & distributors?

Asenapine Maleate manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Asenapine Maleate

Synonyms

85650-56-2, Asenapine (maleate), Sycrest, Asenapine maleate [usan], Org 5222, Org-5222

Cas Number

85650-56-2

Unique Ingredient Identifier (UNII)

CU9463U2E2

Asenapine Manufacturers

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

Asenapine Suppliers

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

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

Asenapine USDMF

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

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

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

Asenapine Manufacturers | Traders | Suppliers

Asenapine 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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