Contract Manufacturing / Third Party Manufacturing
Aclire pharmaceutical is an experienced, well-versed and resourceful pharmaceutical contract manufacturer.
Prominent Attributes :
- Custom Manufacturing Service which offers flexibility to customers
- Development of each product from scratch
- Fully automated and advanced plant
- Contemporary equipments and technology in quality control and assurance
- High standard Labelling and Packaging
- Segregated division for every single dosage form
- Utilize aseptic techniques to retain premium quality
- Enormous annual production competence for each formulation
- Devoted and Diligent professional employees with profound knowledge
We provide fully integrated third party contract manufacturing service. We also provide development solutions to our customers, from early development to high-volume commercial manufacturing and packaging; P to P manufacturing for export formulations with most appropriate quality at most competitive rates backed by a proficient workforce, sophisticated infrastructure and efficient distribution network. Aclire pharmaceutical has robust position to serve as the pharmaceutical industry’s preferred strategic partner.
Private Label Manufacture and Supply
We manufacture our products under private label as per the need of our number of customers from different parts of the world to satisfy their specific requirements.
Neutral Code Service
We can render special code/Neutral code service which are approved by Central Drugs Standard Control Organisation (CDSCO). This service is provided as per the request of clientele to conceal details of the manufacturer in order to maintain their identity. This facility avails only for export purpose.
Aclire pharmaceutical provides loan license service as well. In a loan licensing contract, as per accordance of Drugs & Cosmetics Act 1940 and Drugs & Cosmetics Rules 1945, a loan licensee is a manufacturer of drugs who may be a company or a unit or a body corporate or any other establishment having no drug manufacturing facilities, but who intends to avail himself manufacturing facilities and then markets it under its own name.
- Drug License in Form No.25 (other than items indicated schedule C, C1 & X )
- Drug License in Form No.28 ( items indicated Schedule C & C1)
- Drug License in Form NO.32 ( Cosmetics)
- Ayurveda License in Form 26 E-1 Rule 157-B
- Neutral Code License mere for export
Aclire pharmaceutical furnishes regulatory support through all phases of drug development. Regulatory Strategy plays a pivotal role in the quick, effective and efficient approval of pharmaceutical products. We alleviate the process of getting prompt approval of your products by explaining country specific regulatory strategies.
- Expertise in filing DMFs, ASMFs, COS, and eCTD submission for supplying API’s to the regulated markets.
- Experience in filing of NDA, ANDAs for supplying finished formulations to semi-regulated markets.
- Analytical Studies, Validation, Elemental Analysis, Stability etc. for the active ingredients as well as pharmaceutical products.
- Summary of product characteristics (SmPS)
- Investigational New Drug Application (IND)
- Dossier registration, Dossier writing and review
- Package information leaflets (PIL), Periodic Safety Update Reports (PSUR’s).
- Compilation of Open and Closed parts of DMF’s.
As a long term ethically binding policy, we aim and commit ourselves to only those products that meet international cGMP standards.
Company policy is to maintain the effective Management Systems and Quality Assurance (QA) in accordance with Regulation of the Minister of Health on Good Manufacturing Practice (GMP). The company continuously improves the implemented system by providing high quality services at a competitive level.
Our Quality Control (QC) department is well equipped with very high-tech instruments and systems for carrying out analysis of the raw materials, packing materials, in process samples, finished drug substances, and microbiological analysis. It approves release of materials only after completing all inevitable analysis and found them appropriate. All the procedures in Quality Control are carried out as per SOP.