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

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01 ACIC Europe API & Pharmaceuticals (1)

02 Dipharma (1)

03 F. Hoffmann-La Roche (1)

04 Industriale Chimica s.r.l. (2)

05 Mankind Pharma (1)

06 R L Fine Chem (1)

07 Siegfried AG (1)

08 Sifavitor srl (1)

09 Sun Pharmaceutical Industries Limited (1)

10 Teva API (1)

11 Vasudha Pharma Chem (1)

12 Blank (2)

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01 AMITRIPTYLINE HCL (3)

02 AMITRIPTYLINE HCL B.P. 88/USP (1)

03 AMITRIPTYLINE HCL USP DRUG SUBSTANCE (1)

04 AMITRIPTYLINE HYDROCHLORIDE (3)

05 AMITRIPTYLINE HYDROCHLORIDE USP (4)

06 AMITRYPTILINE HCL (1)

07 PROCEDURES FOR (1)

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01 Cyprus (1)

02 India (4)

03 Israel (1)

04 Italy (4)

05 Switzerland (2)

06 Blank (2)

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01 Active (7)

02 Inactive (7)

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01 Complete (4)

02 Blank (10)

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2908
Active
1977-03-18
N/A
II
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2413
Inactive
1975-03-10
N/A
II
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2535
Inactive
1975-10-06
N/A
II
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33565
Active
2019-07-24
Complete
2019-09-16
2019-07-15
II
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18111
Active
2005-02-10
Complete
2017-03-22
2016-09-26
II
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3008
Inactive
1977-07-17
N/A
II
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2598
Active
1976-01-28
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19589
Active
2006-07-12
N/A
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2719
Active
1976-08-09
Complete
2017-03-17
2017-03-02
II
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19635
Active
2006-07-28
Complete
2015-09-28
2015-09-21
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Looking for 549-18-8 / Amitriptyline Hydrochloride API manufacturers, exporters & distributors?

Amitriptyline Hydrochloride manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Amitriptyline Hydrochloride

Synonyms

549-18-8, Amitriptyline hcl, Annoyltin, Tryptizol, Domical, Syneudon

Cas Number

549-18-8

Unique Ingredient Identifier (UNII)

26LUD4JO9K

About Amitriptyline Hydrochloride

Tricyclic antidepressant with anticholinergic and sedative properties. It appears to prevent the re-uptake of norepinephrine and serotonin at nerve terminals, thus potentiating the action of these neurotransmitters. Amitriptyline also appears to antagonize cholinergic and alpha-1 adrenergic responses to bioactive amines.

Amitriptyline Hydrochloride Manufacturers

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

Amitriptyline Hydrochloride Suppliers

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

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

Amitriptyline Hydrochloride USDMF

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

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

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

Amitriptyline Hydrochloride Manufacturers | Traders | Suppliers

Amitriptyline Hydrochloride 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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