PHARMACEUTICAL CONTRACT MANUFACTURING
5M Biotech offers a contract pharmaceutical manufacturing service in India for complaint third party manufacturing, global pharmaceutical supply through certified networks of manufacturing.
5M Biotech India is however not a manufacturing company, we offer contract manufacturing service. We also offer structured pharma contract for companies looking for regulatory guidance, manufacturing partner, and regulatory supply capabilities.
We carefully select a network of certified manufacturing partners and supports the development, manufacturing, and supply of pharmaceutical products that is aligned with regulatory standards.
01 / PARTNER NETWORK
We partner with multiple manufacturing sites than a single plant. For chemical synthesis we partner with cGMP certified plants along with a fully equipped pilot plant, dedicated packaging lines, and formulation. This allows a sterile injectable program and a high quantity oral solid program to be quoted from the same inquiry. It is a practical advantage for buyers who is sourcing more than one presentation of the same product.
02 / PRODUCT CAPABILITY
03 / FACILITY NETWORK
The facility is selected depending on the program. Not every approval applies to every site so 5M Biotech India makes sure the specific facility and the current approval status during the quotation stage. The batch scale runs from small pilot quantities for development to clinical supply and muti tonne commercial production. The minimum order quantity can vary accordingly by product and process stage.
04 / COORDINATION
The contract manufacturing in India for pharmaceutical products follow a sequence. 5M Biotech India manages each stage on the behalf of the buyer.
01
5M Biotech India will review the dosage, molecule, strength, volume, indicative, along with regulatory considerations and the target market. We confirm if the program is helpful within the partner network before we proceed any further.
02
Then the facility whose equipment and batch scale suits the needs best is identified and the regulatory status is confirmed against the authority the buyer intends to register with.
03
Quality agreements, artworks, product specifications, and the regulatory document set are agreed before production is scheduled. So, there is no need for reconstruction after the fact. Documentation is prepared keeping European Medicines Agency (EMA), Central Drugs Standard Control Organisation (CDSCO), and FDA guidelines in mind along with country-specific import requirements.
04
The pharmaceutical production is carried out according to the approved batch record. All the quality checks are done during production and before release. The steps are properly documented and traceable. Any changes or deviations are reviewed and managed through a documented change control process.
05
After the product is manufactured 5M Biotech India prepares the documentation for export and coordinates shipment under WHO GSDP conditions. We also offer temperature controlled and validated packaging where the products require it.
05 / WHY 5M BIOTECH INDIA
Most other contract manufacturing offers you till factory production. However, 5M Biotech India gives you manufacturing coordination and export options together. So, our team will not only place the program, but will also handle documentation, compliance, and delivery.
5M Biotech will manages all regulatory documentation internally. We will also prepare the CTD and eCTD dossiers, conduct stability studies, and provide support for BA and BE studies.
Since we do not have our own manufacturing plant, so we match each program to the most appropriate partner site.
REGULATORY & COMPLIANCE INFORMATION
5M Biotech India will source your manufacturing and supply under the following guidelines.
