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What is COPPs? How to apply for COPPs (Certificate of Pharmaceutical Products)? – Are you looking for some information regarding COPPs and how to apply for it? If yes, then keep reading because, in this article by Arlak Biotech, we will give you information regarding what is COPPs and How to apply for COPPs. Our company, Arlak Biotech has done its complete research and come up with some useful information for you folks. So without any further due, let’s get started. So what is COPP? COPP is a Certificate of Pharmaceutical Products. It is a certificate that is recommended by the WHO (World Health Organization) and its format is made according to the WHO guidelines. This certificate is important as it is mandatory to submit this certificate to the country importing when the goods are intended for licensing for registrations.

Moreover, for the grant of GMP, WHO certificate, application as per requirement should be made to zonal or subzonal officers. According to the GMP-WHO guidelines and after clearance from CDSCO, the COPP certificate will be issued by Zonal or subzonal officers on behalf of the DCGI. The COPP certificate is valid for around 3 years from the date of issue and one can easily apply for renewal after the expiry.

Below is some information regarding How to apply for COPPs (Certificate of Pharmaceutical Products)? For more information, you can get in touch with Arlak Biotech. Call us at +91-9803023099, 769626336 or you can email us as well at is COPPs? How to apply for COPPs (Certificate of Pharmaceutical Products)

Procedure to apply for COPPs (Certificate of Pharmaceutical Products)?

  • The COPP application must be made to the respective sub-zonal or zonal office as per the requirements. After the complete inspection and receiving clearance from the authorities. On behalf of the DCGI, authorities will issue the certificate.
  • One needs to submit a cover letter and summary of the goods with the application and the application for COPP needs to be directed to the ADC or DDC of the sub-zonal or zonal officer.
  • Now, this point is very crucial. It is mandatory to mention clearly that why you are submitting the application. Is it for acquiring a new certificate or renewal or reissue as the scrutiny process will be done accordingly? After carefully reviewing the application, it is accepted by CDSCP.
  • One needs to submit a list of goods, a summary sheet of goods, a forwarding letter, a site master filer, and a good manufacturing license.
  • Quality manuals are required to be submitted with the application along with the complete specifications, manufacturing layout, master validation plan, and records
  • It is a must to submit a list of people along with their experience, qualification, and designation. Moreover, it is required to submit the details of infrastructure like equipment list, instruments, and utilities.

We hope that through this blog by Arlak Biotech, you got the information that what is COPP and How to apply to COPP. Arlak Biotech did its complete research and collected some useful information which is mentioned above. This blog provides you a broad idea regarding what is COPP, the application process, and how to apply for COPP. But it is always a good thing to check our official site for some more relevant information as rules, regulation or norms keeps changing. If one applies carefully without committing any error, there is a fair chance that one can get it on the first attempt.

The above-provided information is true, authentic, and reliable. If you are looking for a company that is legally approved and has all the legal documents, certifications, or registrations, then associate with Arlak Biotech. We are the best PCD Pharma Franchise Company in India that has acquired all the legal registrations, documents, and certificates. Moreover, we offer monopoly based franchise services across Pan India. For more information, you can contact us. Give us a call at +91-9803023099, 769626336 to know more about us, our products or documents and franchise services and you can email us as well at

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