Expression of Interest
EXPRESSION OF INTEREST
Technical Bid for Empanelment of Manufacturers for Loan Licence / Loan Licence on Turnkey Basis
Karnataka Antibiotics & Pharmaceuticals Limited, (KAPL) is aBangalore based progressive CPSE (Government of India Enterprise) engaged in the manufacturing & marketing of Pharmaceutical formulations to domestic and overseas markets.KAPL has been a profit making organization from the inception.KAPL is a WHO-GMP certified organization with ISO accreditation and has been recognized for the total commitment to quality and services to cater domestic and international markets and also KAPL facilities has been approved by many International countries for the supply of Pharmaceutical products.
KAPL has developed as impressive production infrastructure for a range of Dry Powder Injectables and become core supplier for Govt. of Karnataka.
KAPL is having 2 (two) manufacturing units, one at Peenya Industrial Area, Bangalore of having Dry Powder Injectables, Liquid Injectabels, Tablets, Capsules, Oral Liquids & Veterinary dosage forms facility and another at Dharwad for Ayurvedic Products.
To meet the marketing demand of products, we are now looking for the reputed manufacturer to manufacture and supply of the Pharmaceuticals Dosage forms like Tablets, Capsules, Liquid Orals and LiquidInjectables (Ampoules & Vials) on Loan Licence / Loan Licence on Turnkey Basis.
- Technically qualified Manufacturing facilities are subjected to Audit by KAPL team and the approved Manufacturers (based on Audit by KAPL) are only eligible for financial bid, Lateron.
- Manufacturer should have validManufacturing licenses and Product permission for each product from licensing authorities.
- Manufacturer should have valid revised Schedule-M; Manufacturer having WHO-GMP certificate are preferred.
- Annual Report or A certificate from their Chartered Accountant (CA) certifyingthat, average Annual turnover of manufacturer for manufacturing the drugs in the last three years i.e. 2016-17, 2017-18 and 2018-19 shall not be less than 5 Crores.
- Manufacturing unit must be registered under Factories Act 1948 and should have compliance to GST, Income Tax and other relevant taxations and need to submit the proof of the same (i.e. copy of GST Registration, Income Tax clearance certificate, etc)
- Manufacturer should not be participated for which the firm / company has been blacklisted/debarred/de-registered/banned by any Central or State Government’s Drug procurement agencies due to quality failure or any other reason.
- A Self declaration stating that firm/company has not been de-barred/blacklisted must be submitted.
- Manufacturer is required to incorporate bar codes as per GS1 standards at various packaging levels (primary, secondary and tertiary) or as per KAPL approved specifications.
- Manufacture must haveonsite quality assurance andIn-house quality controlLab for testing & certification.
- Manufacturer should have facility to manufacture either one or all the dosage forms of Tablets, Capsules, oral Liquids and LiquidInjectables (Ampoule & Vial).
- Manufacturer should submit the Site Master file of factory, installed/available spare capacity and Organization structurealong with Bid.
- Manufacturer should providedeclaration for the drugs providing guarantee that the drugs supplied are not spurious.
- Manufacturer must ensure strict compliance to all statutory regulations with furnishing of a “Certificate of Analysis” confirming to IP/BP/USP for each batch for all executed products.
- Manufacturer should provide last two years production details of the drugs supplied duly certified by a chartered accountant.
- Manufacturer is expected to observe the highest standard of ethics during in the procurement and execution of orders.
- The approved artwork for packing materials shall be provided by KAPL.
- Manufacturer should submit the recent “Non-Conviction Certificate” from competent Authority or Self declaration for the same.
- Delivery Schedule: First order shall be supplied within 45 days of receipt of order and subsequent orders shall be supplied within 30 days of receipt of orders.
- The supplier shall grant KAPL’s authorized persons to access its facilities at all reasonable times to appraise the production, testing and packing of goods and shall provide all necessary assistance during the visit.
- In cases of Out of Specifications (OOS) and product failure; the supplier will be required to investigate the discrepancies and report to KAPL and shall replace the goods, pay for the freight cost and the re-inspection fee at cost.
- Distributors/ Suppliers/ Marketer/ Agents/ Importer are not eligible to participate in the Tender
Terms and Conditions:
- Products specification and Artwork of Packing Materials are as per KAPL requirement.
- Supplied each Batch no. must enclose Certificate of Analysis (COA) along with Invoice copy/Delivery challan.
- The medicines / drugs, at the time of receipt should have the latest manufacturing date and minimum remaining expiry period should be 5/6th of the life of the drug.
- Signed copy of Expression of Interest is required &only accepted.
- Financial bid will be invitedfrom technically qualified and approved manufacturers only.
- In case of non-compliance / market complaints, either in the quality of the product or appropriate packaging or agreed labelling, the manufacturer shall take the sole responsibility to replace the complete batch at manufacturer cost or reimburse KAPL and take appropriate actions to eliminate public health risk.
- KAPL reserve the right to suspend procurement of products in case of identification of inferior quality.
- To ensure the quality standard of the products, KAPL reserves the right to conduct audits or technical visits and request for random independent sampling and testing at any time.
- Technical Bid received beyond the closing date, will not be accepted/considered.
- In case of any statutory requirements, manufacturer needs to comply w.r.t. manufacturing activity.
Last date for submission of Technical Bid:
We request you to submit your sealed technical bid by the closing date i.e. before 18.00 hrs on 21-10-2019.
Address for Communication:
KarnatatakaAnitibiotics& Pharmaceuticals Limited
Plot No.14, II Phase
Peenya Industrial Area,