Form-1'S INFORMATION:
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Name of the Formulation *
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Manufacturer/Importer Name*
Please Enter Manufacturer/Importer Name
Manufacturer/Importer Address*
Please Enter Manufacturer/Importer Address
Name of Marketing Company,if any:
Please Enter Name of Marketing Company
Address of Marketing Company,if any:
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Composition as per label claimed and approved by Drug Control Authorities:*
Please Enter Composition as per label approved by DCA
UPLOAD FROM-I'S RELEVANT 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
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Upload Choosed Document*
Current valid SDC License having both the names of Manufacturing and Marketing Company *
Agreement / contract between manufacturer and marketer
If Manufacture and Marketing companies are different then enter both
Any other document(s)
DRUG CONTROL AUTHORITY
Permission Number
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Permission Date*
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Date of commencement of production/import
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Type of formulation *
Please Enter Formulation Type such as (Tablets/ Capsules/ Syrup/ Injection/ Ointment/ Powder etc.)
Size of Packs*
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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The Retail Price claimed for approval *
Please Enter Retail Price claimed for approval
Reason for submission of application for price fixation/ revision *
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Any other information relevant to product and its process of manufacturing/ packaging/distribution. *
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AUTHORITY SIGNATORY
Name *
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Name Of Company *
Please Enter Signatory Company Name
Designation*
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Email Id *
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Mobile No.*
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Place *
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Captcha Code :
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