Digitization of clearance: Price Approval for New Drug - Form I of DPCO 2013
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FORM-I:PROFORMA FOR APPLICATION FOR PRICE FIXATION / REVISION OF A NEW DRUG FORMULATION RELATED TO NLEM FORMULATION
Form-1'S INFORMATION:
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Name of the Formulation
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Please Enter Formulation
Manufacturer/Importer Name
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Please Enter Manufacturer/Importer Name
Manufacturer/Importer Address
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Please Enter Manufacturer/Importer Address
Name of Marketing Company,if any:
Please Enter Name of Marketing Company
Address of Marketing Company,if any:
Please Enter Address of Marketing Company
Composition as per label claimed and approved by Drug Control Authorities:
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Please Enter Composition as per label approved by DCA
Upload Form-I's Relevent Documents
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DCGI's Approval
The Manufacturing Permission granted by the State Lecensing Authority having both the names of manufacturing and marketing company in case of approvals before the cut-off date of 01/10/2012
Inclusion of formulation in India Pharmacopoeia/National Formulatory of India
Please choose Document Catagory
Upload Choosed Document
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Current valid SDC License having both the names of Manufacturing and Marketing Company
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Agreement / contract between manufacturer and marketer
Any other document(s)
Drug Control Authority
Permission Number
*
Please Enter Permission Number
Permission Date
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Please Enter Permission Date
Date of commencement of production/import
Please Enter Date of commencement of production/import
Type of formulation
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Please Enter Formulation Type such as (Tablets/ Capsules/ Syrup/ Injection/ Ointment/ Powder etc.)
Size of Packs
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Please Enter Pack Size such as (10’s/ 100’s/ 1 ml/ 2 ml/ 10 ml/ 5 gms/ 10 gms etc.)
Therapeutic category/ use of the formulation
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Please Enter Therapeutic Catagory
The Retail Price claimed for approval
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Please Enter Retail Price claimed for approval
Reason for submission of application for price fixation/ revision
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Please Enter Reason for submission of application for price fixation/ revision
Any other information relevant to product and its process of manufacturing/ packaging/distribution.
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Please Enter Any other information relevant to product
Authorized Signatory
Name
*
Please Enter Signatory Name
Name Of Company
*
Please Enter Signatory Company Name
Designation
*
Please Enter Signatory Designation
Email Id
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Please Enter Signatory Email Id
Mobile No.
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Please Enter Signatory Mobile No.
Place
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Please Enter Signatory Place
Captcha Code :
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