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Clindamycin | CAS No: 18323-44-9 | GMP-certified suppliers
A medication that treats serious anaerobic and gram‑positive infections, supports acne management, addresses bacterial vaginosis, and provides prophylaxis for select high‑risk bacterial complications.
Therapeutic categories
Agents that produce neuromuscular block (indirect)Anti-Acne PreparationsAnti-Acne Preparations for Topical UseAnti-Bacterial AgentsAnti-Infective AgentsAntibacterials for Systemic Use
Generic name
Clindamycin
Molecule type
small molecule
CAS number
18323-44-9
DrugBank ID
DB01190
Approval status
Approved drug, Vet_approved drug
ATC code
D10AF01
Primary indications
- In oral and parenteral formulations, clindamycin is indicated for the treatment of serious infections caused by susceptible anaerobic bacteria, as well as susceptible staphylococci, streptococci, and pneumococci
- Used topically, it is indicated for the treatment of acne vulgarisand is available in combination with [benzoyl peroxide]or [tretinoin]for this purpose, or as a triple combination therapy with benzoyl peroxide and [adapalene]
- Clindamycin is also indicated as a vaginal cream, suppository, or gelfor the treatment of bacterial vaginosis in non-pregnant females
- Clindamycin is used for antimicrobial prophylaxis against _Viridans_ group streptococcal infections in susceptible patients undergoing oral, dental, or upper respiratory surgery, and may be used for prophylaxis against bacterial endocarditis in penicillin-allergic patients at high risk of these infections
Product Snapshot
- Clindamycin is an oral, injectable, topical, and vaginal small-molecule antibiotic available across multiple human and veterinary formulations
- It is used for anaerobic and gram‑positive bacterial infection management, acne applications, bacterial vaginosis, and select surgical or endocarditis prophylaxis scenarios
- It is approved in the US and Canada for human and veterinary use
Clinical Overview
Clindamycin (CAS 18323-44-9) is a semi-synthetic lincosamide antibiotic used systemically for serious infections caused by susceptible anaerobes and gram‑positive organisms, including staphylococci, streptococci, and pneumococci. Topical formulations are used for acne vulgaris, either alone or in fixed combinations with benzoyl peroxide, tretinoin, or adapalene. Vaginal preparations are indicated for bacterial vaginosis in non‑pregnant adults. Clindamycin is also used in specific prophylactic settings for patients at risk of viridans group streptococcal infection or bacterial endocarditis when penicillin is unsuitable.
Clinically, clindamycin provides bacteriostatic activity with a relatively narrow spectrum that includes gram‑positive aerobes and both gram‑positive and gram‑negative anaerobes. Off‑label uses have included certain protozoal infections such as toxoplasmosis, malaria, and babesiosis.
Clindamycin inhibits bacterial protein synthesis by binding to 23S rRNA of the 50S ribosomal subunit, interfering with ribosomal assembly and elongation. Its structural similarity to tRNA intermediates contributes to impaired peptide chain initiation and potential dissociation of peptidyl‑tRNA. In acne, therapeutic benefit is thought to relate to activity against Cutibacterium acnes.
Oral absorption is generally rapid with a short time to peak concentration, and the elimination half‑life supports dosing every six hours in standard regimens. Clindamycin is metabolized primarily by CYP3A pathways and acts as both a substrate and moderate inhibitor. It is also a P‑glycoprotein substrate.
Safety considerations include the established risk of Clostridioides difficile associated diarrhea, which may occur during therapy or weeks after discontinuation. Resistance arises mainly from 23S rRNA modification and may confer cross‑resistance with macrolides and lincomycin.
Notable brand contexts include systemic and topical formulations available globally. For API procurement, manufacturers should verify compliance with pharmacopeial specifications, microbial limits, impurity controls, and robust traceability of fermentation‑derived starting materials.
Clinically, clindamycin provides bacteriostatic activity with a relatively narrow spectrum that includes gram‑positive aerobes and both gram‑positive and gram‑negative anaerobes. Off‑label uses have included certain protozoal infections such as toxoplasmosis, malaria, and babesiosis.
Clindamycin inhibits bacterial protein synthesis by binding to 23S rRNA of the 50S ribosomal subunit, interfering with ribosomal assembly and elongation. Its structural similarity to tRNA intermediates contributes to impaired peptide chain initiation and potential dissociation of peptidyl‑tRNA. In acne, therapeutic benefit is thought to relate to activity against Cutibacterium acnes.
Oral absorption is generally rapid with a short time to peak concentration, and the elimination half‑life supports dosing every six hours in standard regimens. Clindamycin is metabolized primarily by CYP3A pathways and acts as both a substrate and moderate inhibitor. It is also a P‑glycoprotein substrate.
Safety considerations include the established risk of Clostridioides difficile associated diarrhea, which may occur during therapy or weeks after discontinuation. Resistance arises mainly from 23S rRNA modification and may confer cross‑resistance with macrolides and lincomycin.
Notable brand contexts include systemic and topical formulations available globally. For API procurement, manufacturers should verify compliance with pharmacopeial specifications, microbial limits, impurity controls, and robust traceability of fermentation‑derived starting materials.
Identification & chemistry
| Generic name | Clindamycin |
|---|---|
| Molecule type | Small molecule |
| CAS | 18323-44-9 |
| UNII | 3U02EL437C |
| DrugBank ID | DB01190 |
Pharmacology
| Summary | Clindamycin is a lincosamide antibiotic that inhibits bacterial protein synthesis by binding to the 23S rRNA of the 50S ribosomal subunit, disrupting ribosome assembly and peptide elongation. It produces primarily bacteriostatic effects against susceptible gram‑positive organisms and anaerobes, with resistance commonly arising from ribosomal RNA modification. In topical use, its benefit in acne is attributed to activity against Cutibacterium acnes. |
|---|---|
| Mechanism of action | Clindamycin inhibits bacterial protein synthesis by binding to 23S RNA of the 50S subunit of the bacterial ribosome.It impedes both the assembly of the ribosome and the translation process.The molecular mechanism through which this occurs is thought to be due to clindamycin's three-dimensional structure, which closely resembles the 3'-ends of L-Pro-Met-tRNA and deacylated-tRNA during the peptide elongation cycle - in acting as a structural analog of these tRNA molecules, clindamycin impairs peptide chain initiation and may stimulate dissociation of peptidyl-tRNA from bacterial ribosomes. The mechanism through which topical clindamycin treats acne vulgaris is unclear, but may be related to its activity against _Propionibacterium acnes_, a bacteria that has been associated with acne. |
| Pharmacodynamics | Clindamycin exerts its bacteriostatic effect via inhibition of microbial protein synthesis.Clindamycin has a relatively short T<sub>max</sub> and half-life necessitating administration every six hours to ensure adequate antibiotic concentrations. _Clostridium difficile_ associated diarrhea (CDAD) has been observed in patients using clindamycin, ranging in severity from mild diarrhea to fatal colitis and occasionally occurring over two months following cessation of antibiotic therapy.Overgrowth of _C. difficile_ resulting from antibiotic use, along with its production of A and B toxins, contributes to morbidity and mortality in these patients. Because of the associated risks, clindamycin should be reserved for serious infections for which the use of less toxic antimicrobial agents are inappropriate. Clindamycin is active against a number of gram-positive aerobic bacteria, as well as both gram-positive and gram-negative anaerobes.Resistance to clindamycin may develop, and is generally the result of base modification within the 23S ribosomal RNA. Cross-resistance between clindamycin and lincomycin is complete, and may also occur between clindamycin and macrolide antibiotics (e.g. [erythromycin]) due to similarities in their binding sites. As antimicrobial susceptibility patterns are geographically distinct, local antibiograms should be consulted to ensure adequate coverage of relevant pathogens prior to use. |
Targets
| Target | Organism | Actions |
|---|---|---|
| 50S ribosomal protein L1 | Staphylococcus aureus (strain NCTC 8325) | inhibitor |
ADME / PK
| Absorption | Oral bioavailability is nearly complete, at approximately 90%, and peak serum concentrations (C<sub>max</sub>) of, on average, 2.50 µg/mL are reached at 0.75 hours (T<sub>max</sub>).The AUC following an orally administered dose of 300mg was found to be approximately 11 µg•hr/mL.Systemic exposure from the administration of vaginal suppository formulations is 40-fold to 50-fold lower than that observed following parenteral administrationand the C<sub>max</sub> observed following administration of vaginal cream formulations was 0.1% of that observed following parenteral administration. |
|---|---|
| Half-life | The elimination half-life of clindamycin is about 3 hours in adults and 2.5 hours in children.Half-life is increased to approximately 4 hours in the elderly. |
| Protein binding | Clindamycin protein binding is concentration-dependent and ranges from 60-94%. It is bound primarily to alpha-1-acid glycoprotein in the serum. |
| Metabolism | Clindamycin undergoes hepatic metabolism mediated primarily by CYP3A4 and, to a lesser extent, CYP3A5.Two inactive metabolites have been identified - an oxidative metabolite, clindamycin sulfoxide, and an N-demethylated metabolite, N-desmethylclindamycin. |
| Route of elimination | Approximately 10% of clindamycin bioactivity is excreted in the urine and 3.6% in the feces, with the remainder excreted as inactive metabolites. |
| Volume of distribution | Clindamycin is widely distributed in the body, including into bone, but does not distribute into cerebrospinal fluid. The volume of distribution has been variably estimated between 43-74 L. |
| Clearance | The plasma clearance of clindamycin is estimated to be 12.3-17.4 L/h, and is reduced in patients with cirrhosis and altered in those with anemia. |
Formulation & handling
- Oral solid and liquid forms show good absorption independent of food, with hydration needed to avoid esophageal irritation from lodged dosage forms.
- Solution concentrates for IV/IM use require appropriate dilution and pH control to maintain stability and minimize injection-site irritation.
- Topical and vaginal formulations leverage the API’s moderate aqueous solubility and stability, with minimal systemic exposure considerations.
Regulatory status
| Lifecycle | The API shows a mature lifecycle in the US and Canada, with several foundational US patents expired and remaining protection concentrated in one patent extending to 2026. Market conditions suggest established generic presence with limited remaining exclusivity tied to the final expiring patent. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Clindamycin is an established antibiotic with several historical originators, but today the market is dominated by numerous packagers and generic manufacturers supplying a wide range of formulations. Branded and combination products are present in the US and Canada, though most primary composition-of-matter protections expired long ago, with only some formulation‑specific patents extending into the mid‑2020s. As a result, broad generic competition is already well established, and any remaining formulation patents suggest only limited residual exclusivity for certain combinations. |
|---|
Safety
| Toxicity | The oral LD<sub>50</sub> in mice and rats is 2540 mg/kg and 2190 mg/kg, respectively. While no cases of overdose have been reported, symptoms are expected to be consistent with the adverse effect profile of clindamycin and may therefore include abdominal pain, nausea, vomiting, and diarrhea. During clinical trials, one 3-year-old child was given a dose of 100 mg/kg daily for 5 days and showed only mild abdominal pain and diarrhea.Activated charcoal may be of value to remove unabsorbed drug, but hemodialysis and peritoneal dialysis are ineffective.General supportive measures are recommended in cases of clindamycin overdose. |
|---|
High Level Warnings:
- Oral LD50 values of 2540 mg/kg (mouse) and 2190 mg/kg (rat) indicate relatively low acute toxicity but necessitate controlled handling to limit high‑dose exposure
- Adverse‑effect profile includes gastrointestinal irritation (abdominal pain, nausea, vomiting, diarrhea), which can manifest with excessive exposure
- The compound is not effectively removed by hemodialysis or peritoneal dialysis, underscoring the importance of preventing significant accidental ingestion during manufacturing or handling
Clindamycin is a type of Antibacterials
Antibacterials, a category of pharmaceutical active pharmaceutical ingredients (APIs), play a crucial role in combating bacterial infections. These APIs are chemical compounds that target and inhibit the growth or kill bacteria, helping to eliminate harmful bacterial pathogens from the body.
Antibacterials are essential for the treatment of various bacterial infections, including respiratory tract infections, urinary tract infections, skin and soft tissue infections, and more. They are commonly prescribed by healthcare professionals to combat both mild and severe bacterial infections.
Within the category of antibacterials, there are different classes and subclasses of APIs, each with distinct mechanisms of action and target bacteria. Some commonly used antibacterials include penicillins, cephalosporins, tetracyclines, macrolides, and fluoroquinolones. These APIs work by interfering with various aspects of bacterial cellular processes, such as cell wall synthesis, protein synthesis, DNA replication, or enzyme activity.
The development and production of antibacterial APIs require stringent quality control measures to ensure their safety, efficacy, and purity. Pharmaceutical manufacturers must adhere to Good Manufacturing Practices (GMP) and follow rigorous testing protocols to guarantee the quality and consistency of these APIs.
As bacterial resistance to antibiotics continues to be a significant concern, ongoing research and development efforts aim to discover and develop new antibacterial APIs. The evolution of antibacterials plays a crucial role in combating emerging bacterial strains and ensuring effective treatment options for infectious diseases.
In summary, antibacterials are a vital category of pharmaceutical APIs used to treat bacterial infections. They are designed to inhibit or kill bacteria, and their development requires strict adherence to quality control standards. By continually advancing research in this field, scientists and pharmaceutical companies can contribute to the ongoing battle against bacterial infections.
Clindamycin API manufacturers & distributors
Compare qualified Clindamycin API suppliers worldwide. We currently have 21 companies offering Clindamycin API, with manufacturing taking place in 6 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| ACS Dobfar | Producer | Italy | Italy | CEP, CoA, FDA, GMP | 36 products |
| Alchymars ICM SM | Producer | India | India | CoA, USDMF, WC | 8 products |
| Apollo Healthcare Resourc... | Distributor | Singapore | Singapore | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC | 200 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF, WC | 250 products |
| Changzhou Comwin Fine Che... | Producer | China | China | BSE/TSE, CoA, GMP, ISO9001, MSDS, WC | 235 products |
| Chongqing Carelife | Producer | China | China | CEP, CoA, FDA, GMP, JDMF, USDMF, WC | 8 products |
| Chongqing Land Tower | Producer | China | China | CoA, WC | 5 products |
| Duchefa Farma B.V. | Distributor | Netherlands | China | CoA, GMP, ISO9001, MSDS | 170 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Lupin | Producer | India | India | CoA, GMP, USDMF, WC | 155 products |
| Mylan | Producer | India | India | CoA, USDMF | 201 products |
| Pharmacia & Upjohn | Producer | United States | United States | CoA, USDMF | 30 products |
| Rochem International, Inc... | Distributor | United States | United States | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, USDMF | 144 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Shandong Fangming | Producer | China | China | CoA, WC | 4 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, USDMF | 757 products |
| Solfyn International LLP | Distributor | India | India | CoA | 24 products |
| Suzhou No.4 | Producer | China | China | CoA, JDMF | 2 products |
| Xinyu Pharma | Producer | China | China | CoA, USDMF | 3 products |
| Zhejiang Hisoar | Producer | China | China | CEP, CoA, FDA, GMP, USDMF, WC | 10 products |
| Zhejiang Tiantai | Producer | China | China | CEP, CoA, FDA, GMP, USDMF | 7 products |
When sending a request, specify which Clindamycin API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Clindamycin API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
Frequently asked questions about Clindamycin API
Sourcing
What matters most when sourcing GMP-grade Clindamycin?
Prioritize suppliers with demonstrated GMP compliance and clear documentation supporting US and Canadian regulatory expectations. Ensure the API’s quality aligns with established monographs and that traceability is maintained across a fragmented generic supply base. Confirm that any formulation‑specific patent considerations do not affect the intended use or procurement timelines.
Which documents are typically required when sourcing Clindamycin API?
Request the core API documentation set: CoA (21 companies), GMP (13 companies), USDMF (13 companies), WC (9 companies), CEP (9 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Clindamycin API?
Known or reported manufacturers for Clindamycin: Duchefa Farma B.V., Changzhou Comwin Fine Chemicals Co., Ltd, Aurora Industry Co., Ltd, SETV Global, Sinoway industrial Co.,Ltd, Apollo Healthcare Resources (Singapore), LGM Pharma, Rochem International, Inc.. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Clindamycin API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Clindamycin manufacturers?
Audit reports may be requested for Clindamycin: 7 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Clindamycin API on Pharmaoffer?
Reported supplier count for Clindamycin: 21 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Clindamycin API?
Production countries reported for Clindamycin: China (11 producers), India (5 producers), United States (2 producers). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Clindamycin usually hold?
Common certifications for Clindamycin suppliers: CoA (21 companies), GMP (13 companies), USDMF (13 companies), WC (9 companies), CEP (9 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Clindamycin (CAS 18323-44-9) used for?
Clindamycin is used to treat serious infections caused by susceptible anaerobic bacteria and gram‑positive organisms, including staphylococci, streptococci, and pneumococci. Topical forms are used for acne vulgaris, and vaginal formulations are indicated for bacterial vaginosis in non‑pregnant adults. It is also used for prophylaxis in patients at risk of viridans group streptococcal infection or endocarditis when penicillin is unsuitable, and has documented off‑label use for certain protozoal infections.
Which therapeutic class does Clindamycin fall into?
Clindamycin belongs to the following therapeutic categories: Agents that produce neuromuscular block (indirect), Anti-Acne Preparations, Anti-Acne Preparations for Topical Use, Anti-Bacterial Agents, Anti-Infective Agents. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Clindamycin mainly prescribed for?
The primary indications for Clindamycin: In oral and parenteral formulations, Clindamycin is indicated for the treatment of serious infections caused by susceptible anaerobic bacteria, as well as susceptible staphylococci, streptococci, and pneumococci, Used topically, it is indicated for the treatment of acne vulgarisand is available in combination with [benzoyl peroxide]or [tretinoin]for this purpose, or as a triple combination therapy with benzoyl peroxide and [adapalene], Clindamycin is also indicated as a vaginal cream, suppository, or gelfor the treatment of bacterial vaginosis in non-pregnant females, Clindamycin is used for antimicrobial prophylaxis against _Viridans_ group streptococcal infections in susceptible patients undergoing oral, dental, or upper respiratory surgery, and may be used for prophylaxis against bacterial endocarditis in penicillin-allergic patients at high risk of these infections. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Clindamycin work?
Clindamycin inhibits bacterial protein synthesis by binding to 23S RNA of the 50S subunit of the bacterial ribosome.It impedes both the assembly of the ribosome and the translation process.The molecular mechanism through which this occurs is thought to be due to Clindamycin's three-dimensional structure, which closely resembles the 3'-ends of L-Pro-Met-tRNA and deacylated-tRNA during the peptide elongation cycle - in acting as a structural analog of these tRNA molecules, Clindamycin impairs peptide chain initiation and may stimulate dissociation of peptidyl-tRNA from bacterial ribosomes.
The mechanism through which topical Clindamycin treats acne vulgaris is unclear, but may be related to its activity against _Propionibacterium acnes_, a bacteria that has been associated with acne.
What should someone know about the safety or toxicity profile of Clindamycin?
Clindamycin has relatively low acute toxicity based on oral LD50 values in rodents, but high‑dose exposure should be avoided and handled under controlled conditions. Gastrointestinal irritation, including abdominal pain, nausea, vomiting, and diarrhea, can occur with excessive exposure. It is not effectively removed by hemodialysis or peritoneal dialysis, making prevention of significant accidental ingestion important. A known clinical risk is Clostridioides difficile–associated diarrhea, which may arise during treatment or after discontinuation.
What are important formulation and handling considerations for Clindamycin as an API?
Important considerations include accounting for Clindamycin’s moderate aqueous solubility and ensuring adequate hydration in oral solid forms to reduce the risk of esophageal irritation if a dosage form lodges. Parenteral solutions require appropriate dilution and pH control to maintain stability and limit injection‑site irritation. Topical and vaginal formulations should be designed to sustain stability while recognizing their minimal systemic exposure.
Is Clindamycin a small molecule?
Clindamycin is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Clindamycin?
Oral Clindamycin solid and liquid formulations are generally stable under standard conditions, with no special stability issues noted. Adequate hydration is recommended to prevent tablets or capsules from lodging in the esophagus, which can cause irritation. Absorption is not affected by food, and no additional formulation‑specific stability concerns are described.
Regulatory
Where is Clindamycin approved or in use globally?
Clindamycin is reported as approved in the following major regions: US, Canada. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Clindamycin right now?
The context indicates that Clindamycin has regulatory presence in the United States and Canada. No specific patent protections or exclusivities are noted in the provided information. Accordingly, the ingredient appears to be governed primarily by standard regulatory oversight in these markets.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Clindamycin procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Clindamycin. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Clindamycin included in the PRO Data Insights coverage?
PRO Data Insights coverage for Clindamycin: 3403 verified transactions across 731 suppliers and 580 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Clindamycin?
Market report availability for Clindamycin: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
