State approvals / Andhra Pradesh / Drug Control Administration
License for manufacture of bulk drugs / formulations
This approval is provided by Andhra Pradesh
DepartmentDrug Control Administration
TypeNew
StagePre-Establishment
Time limit15 working days
FeeNo fee
Applied—
Documents to submit
| # | Document | Condition | Required |
|---|---|---|---|
| 1 | Statutory Form 24/27 | — | Required |
| 2 | Affidavit-II (enclosed with online form) attested by Notary regarding the name, address and other details of the persons responsible to the day-to-day affairs of the company and for the conduct of business along with his photograph duly attested | — | Required |
| 3 | Attested copies of certificates academic qualifications, experience certificates, Bio-data and declarations of Technical Staff in the prescribed proforma with attested photos | — | Required |
| 4 | Attested copies of documents relating to the ownership/rent/lease | — | Required |
| 5 | Attested copy of Ration Card or Passport or Electoral Card in support of the residential address of the responsible person | — | Required |
| 6 | Brief manufacturing procedure and Flow Chart along with consumption coefficient of effluents generated and their treatment for the drug applied for along with the method and procedure of Test/Analysis | — | Required |
| 7 | Clearance from Drugs Controller General (India), New Delhi in case of new drugs (Either Bulk Drug or Formulation) New drugs are defined under Rule 122 E of the Drugs and Cosmetic Rules 1945 | — | Required |
| 8 | Declaration of the proprietor/Partnership/Director etc, in Affidavit-I (enclosed with online form), attested copies of Partnership Deed/Memorandum and Articles of Association | — | Required |
| 9 | Detailed list of Manufacturing and Analytical Equipment with copies of purchase bills | — | Required |
| 10 | Plan and layout of the premises showing the installation of Machinery and Equipment | — | Required |
| 11 | Copies of monographs of drugs, which are not included in I.P | — | Required |
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