Trusted API Manufacturing Partner Delivering Quality & Innovation
Reine Lifescience is a globally recognized pharmaceutical API manufacturer based in Ankleshwar, India. With cGMP-compliant facilities and advanced infrastructure, we manufacture high-quality Active Pharmaceutical Ingredients for regulated global markets.
Our integrated operations, experienced leadership, strong quality systems, and commitment to regulatory excellence position us as a reliable long-term partner for pharmaceutical companies worldwide.
Advanced API Manufacturing for Global Markets
Reine Lifescience operates cGMP compliant facilities in Ankleshwar delivering high quality Active Pharmaceutical Ingredients to regulated markets worldwide.
- Modern infrastructure with integrated QA QC & R&D
- International regulatory compliance
- Scalable manufacturing capacity
Our Product Range
| Sr. No. | Product | Category | Specs |
|---|---|---|---|
| 1 | Amiodarone HCL | Anti-Arrhythmic | IP / BP / EP / USP / DMF | <
| 2 | Apixaban | Anticoagulant | IH / DMF |
| 3 | Atorvastatin Calcium | Cardiovascular | IP / BP / EP / USP |
| 4 | Atorvastatin Strontium | Cardiovascular | IH |
| 5 | Baclofen | Antispasmodic | IP / BP / EP / USP |
| 6 | Benzocaine | Anaesthetics | BP / EP / USP |
| 7 | Bilastine | Anti-Allergic | IP |
| 8 | Deferasirox | Iron Chelator | IP / BP / EP |
| 9 | Deferiprone | Iron Chelator | BP / EP |
| 10 | Doxofylline | Anti-Asthmatic | IP / USP |
| 11 | Ethambutol HCL | Anti-Tubercular | IP / BP / EP / USP |
| 12 | Itopride | Gastro Prokinetic | IH |
| 13 | Labetalol HCL | Anti-Hypertension | IP / BP / EP / USP |
| 14 | Letrozole | Anti-Estrogen | IP / BP / EP / USP |
| 15 | Metoprolol Succinate | Anti-Hypertension | IP / BP / EP / USP |
| 16 | Metoprolol Tartrate | Anti-Hypertension | IP / BP / EP / USP |
| 17 | Minoxidil | Anti-Hypertension | IP / BP / EP / USP |
| 18 | Mirogabalin Besylate | Neuropathic Pain | IH |
| 19 | Phenylbutazone | NSAID | BP / EP / USP |
| 20 | Pregabalin | Anti-Epilepsy | IP / BP / EP / USP |
| 21 | Rosuvastatin Calcium | Cardiovascular | IP / BP / EP / USP |
| 22 | Sitagliptin Phosphate Monohydrate | DPP-4 | IP / BP / EP / USP |
| 23 | Teneligliptin HBr | Anti-Diabetic | IP |
| 24 | Teneligliptin HCL | Anti-Diabetic | IH |
| 25 | Torsemide | Anti-Hypertension | IP / BP / EP / USP |
| 26 | Trazodone HCL | Anti-Depressant | IP / BP / EP / USP |
| 27 | Erdosteine | Anti-Mucolytic | IH |
| Sr. No. | Product |
|---|---|
| 28 | Bempedoic Acid |
| 29 | Fimasartan |
| 30 | Iopamidol |
| 31 | Luliconazole |
| 32 | Minoxidil Sulphate |
Reine’s API Expertise: Capabilities at a Glance
At Reine Lifescience, we deliver integrated API manufacturing capabilities aligned with global regulatory standards, ensuring quality, scalability, and reliability.
Three Decades of Excellence
From chemical intermediates to a globally-recognised pharmaceutical API manufacturer —
our journey defined by quality and commitment.
Established as Reine Chemicals Pvt. Ltd.
Foundation laid with a vision to manufacture high-quality chemical intermediates.
Transition to Reine Lifescience
Strategic expansion into pharmaceutical APIs and regulated markets.
WHO Inspection
Successful WHO inspection strengthening global regulatory credibility.
CEP Customer Audit
Reinforcing regulatory alignment and quality excellence.
WHO-GMP Approval
Demonstrating advanced manufacturing compliance standards.
MFDS Korea Approval
Expanded regulatory footprint in Asian pharmaceutical markets.
Sri Lanka Audit
Reinforcing regulatory alignment and quality excellence.
Anvisa Inspection Completed
Strengthening regulatory presence across Latin America.
Approved Anvisa Brazil
A Proud Milestone in our commitment to QUALITY, COMPLIANCE & EXCELLENCE.
Our Latest Accredited's
International Expo & Events
Meet us at leading pharmaceutical exhibitions across the globe
CPHI MILAN
06-08 Oct 2026 · Fiera Milano, Italy
CPHI MILAN
06-08 Oct 2026 · Fiera Milano, Italy
CPHI Frankfurt
Oct 2025 · Germany
CPHI India
Nov 2025 · India
CPHI China
June 2026 · China
CPHI THAILAND
July 2026 · Bangkok
CPHI KOREA
August 2026 · Seoul
CPHI Frankfurt
Oct 2025 · Germany
CPHI India
Nov 2025 · India
CPHI China
June 2026 · China
CPHI THAILAND
July 2026 · Bangkok
CPHI KOREA
August 2026 · Seoul
Frequently Asked Questions
Everything buyers ask about our APIs, certifications, exports and documentation.
What is an API manufacturer?
A company that makes the active ingredient used in medicines. Reine Lifescience is an API manufacturer in Ankleshwar, India.
What APIs does Reine Lifescience manufacture?
27 APIs incl. Atorvastatin, Rosuvastatin, Pregabalin, Sitagliptin and Apixaban. See the API portfolio.
Where is Reine Lifescience located?
Plot No. 5901, Kanoria Chemicals Road, GIDC Ankleshwar 393002, Gujarat, India.
What certifications does Reine Lifescience have?
WHO-GMP, EDQM CEP, MFDS Korea, ANVISA Brazil, FDCA GMP/S-GLP and ISO 9001, 14001, 45001. Details.
What is WHO-GMP certification for APIs?
WHO certification that an API plant meets international manufacturing and quality standards.
What is CEP certification for APIs?
An EDQM (Europe) certificate confirming API quality per the European Pharmacopoeia; it eases EU registrations.
What is an API DMF?
Drug Master File: a confidential dossier on API manufacturing and controls, referenced in drug filings. Reine provides DMF support.
What is cGMP API manufacturing?
Producing APIs under current Good Manufacturing Practice with validated, documented quality systems.
What are IP, BP, EP and USP standards?
Indian, British, European and US pharmacopoeias that define API quality tests and limits.
How are pharmaceutical APIs manufactured?
By multi-step chemical synthesis, then purification, drying and QC testing before batch release.
How to choose an API manufacturer in India?
Check GMP/CEP approvals, DMF, CoA, impurity and stability data, audit history and supply reliability.
Why source APIs from India?
Strong chemistry expertise, many regulator-approved plants and competitive costs for global supply.
Does Reine Lifescience export APIs?
Yes, to regulated and semi-regulated markets including Europe, South Korea and Brazil.
Does Reine Lifescience offer CDMO and custom API development?
Yes: custom synthesis, process development, scale-up, tech transfer and DMF support. See CDMO.
What does API process development include?
Route design, method validation, impurity profiling, stability studies and tech transfer to plant scale.
How to request an API quote, CoA or regulatory documents?
Use any product page form or contact us with product, grade, quantity and country.
How to contact Reine Lifescience international sales?
Email info@reinelifescience.com or call +91 63560 38460 / +91 63561 38460.